Q ~ Trust Trump's Plan ~ 09/08/21 Vol.369, Q Day 1412

qalerts.net ^ | 9/8/2021 | FReeQs, FReepers, and vanity

[bitt]

BREAKING: What appears to be Joe Biden’s motorcade BOOED massively by Patriots at Long Beach City College @RealAmVoice pic.twitter.com/04y06RlcJA— Drew Hernandez (@DrewHLive) September 14, 2021

[bitt]

@NickForVA
· 12h
Before the left gets all excited about the vaccine precedent set in 1905 in Jacobson v. Mass, please remember that was the same case that was later used to justify forced sterilization. So you might want to be careful about the court decisions you use to justify your actions.

[nclaurel]

Seems like il Presidento Trumpo puts Pence in with the creeps.

https://rumble.com/vmew3r-i-love-mi-amigo-lin-wood.html

[MomwithHope]

"Yep. It’s everywhere. Grocery checkout mag covers are loaded with it." Hubby saw this yesterday in the checkout lane and snapped a pic, someone drew a mustache on Biden.

[AFB-XYZ]

LOL — I only knew that because I had to change the HEPA filter on my sister’s vacuum cleaner last year.

She needs to find a nice guy to do all that stuff for her. But at least I was useful for something. :-)

[Pete from Shawnee Mission]

Servlex Good to know!

[AZLiberty]

I saw this on Telegram, then found the YouTube so I could link it: https://youtu.be/wDv0gufOnIk?t=359

Justin Trudeau refusing to respond to powerful question from Canada’s Rebel Media. The question was about Israel’s experience as a fully vaxxed country.

[gymbeau]

Rebel Media is one of the only non-bought and paid for media outlets here.

[AZLiberty]

“Show Me The Writ!” — The Spirit You Must Always Have In Order To Be Free

Excellent. Thank you!

FWIW, this is pure Alinsky:

Rule 4. “Make the enemy live up to its own book of rules.”

[numberonepal]

I were to decide to do so, can anyone tell me which of the available vax’s are the safest options?

There is no safe option. The likelihood of you being dead in 3-5 years is good. Resist.

[Axenolith]

I’d be willing to bet a big sum that “Politics Jack” ain’t gettin’ at the head of any “Stack”...

[ransomnote]

Spike Proteins In Immune Cells - Dr. Bruce Patterson Discusses COVID Long Haul - YouTubeComputer generated transcript may contain phonetic errors and lacks punctuation. Video at link is 1 hour and 24 minutes in length.

 

 

Streamed live on Jun 24, 2021

 

this is dr mobiensa here from

doctorbean.com

welcome to one more show so today we

have a rockstar with us once more we

have had dr

bruce peterson with us before too i

think the importance

of the talk today probably

one of the most important talks that you

would hear we are actually fortunate to

have him with us

the reason is that he has discoveries

for long-haul patients in their

pathology

and the implications and the usage of

those discoveries for the management of

the patient is very important

and i feel that as this pandemic it

seems to me

is winding down the patients who are

long-haul

they are actually increasing and they

are continuing to be in that miserable

state

so the work for dr bruce patterson i

think is going to be and his team is

going to be

groundbreaking to help us get ahead of

that

and i did not tell him this but today i

was talking with some team members with

his friends to see how can we nominate

dr pierre corey and dr bruce patterson

for nobel prize we'll see what happens

but this is how

important i feel these discoveries are

in these

uh these findings are so please

help me welcome dr bruce pettis and

welcome dr bruce matterson

thank you dr bean it's always a pleasure

to be on your show and uh

have our lively discussions and um

i'm sure we'll we'll run over time so

this is uh very exciting for me to be on

your show thank you

thank you very much and then very

quickly i'm gonna

share some of the links here that are

present in the discussion as well

so cool beans this is doctorbean.com

this is dr bruce peterson's uh webpage

called

covet longhaulers.com i want to give a

full disclaimer as well

that i have no commercial interest here

i have no

other interest here other than having dr

patterson

here share his knowledge with you all

and whatever benefit can come to cool

beans will arrive

that is my interest there is no other

commercial financial

or influence related link here

this is also while we're talking about

the

long haul this is flccc site where

long-haul protocol which i had led in

this protocol

dr bruce petterson's team has input as

well

although i feel that their own protocol

that we'll talk with dr patterson

needs a lot of discussion and review for

us as well and usage too

so with this uh let's start so dr

peterson the first question

what can i just start calling you bruce

of course

so bruce the first question what is

long-haul

um is it so two questions here actually

what is long-haul are you seeing it

after covet and

are you seeing it after vaccine boy

that's that's such a great question

um and you know our our big paper just

came out last week in frontiers in

immunology

and it really uh set out um

who is a long hauler and what is a long

hauler

and really the the gist of the paper was

that

we used machine learning to look at a

variety of different biomarkers

uh we started with probably over a

hundred

we narrowed it down to 14 and then we

used those 14

to see what the difference was were

between

uh long haulers severe coveted

mild to moderate covet and normal

individuals

and indeed there it was a very very

distinct

set um you know 99

distinct from active covid um

and it was truly uh its own immunologic

signature

and we developed the long hauler index

so that we could quantify

non-subjectively who is a long-hauler

from a diagnostic standpoint and most

importantly monitor them on therapy

because i know you you know very well

dr bean when you talk to these

individuals their stories are

completely different um and they have

day-to-day variations which

we'll talk about in a moment and to try

and grasp

any uh information in terms of recovery

treatment uh how they're feeling what

they're feeling

and they've been debilitated for months

on end so what's the

what's the contribution of having to be

debilitated

uh in terms of their symptom complex is

so complicated um that i know we

couldn't do it without um

the machine learning and and computer

assistance

got it thank you very much for this and

uh cool beans we're gonna continue to

discuss and go deeper and deeper

i hope that you would come along and and

have that

fascinating discussion one more question

uh

bruce the long haulers the ones that

i've been managing i'm sure that the

ones that you are managing

they go through this hills and valleys

so there was a cool bean here simple

garden who asked this question

that there are flare-ups do you know why

that happens

we do now i mean i think with the paper

setting the stage last week of what is a

long hauler

and and in fact um we were able to get

data

into our paper uh that in frontiers of

in

immunology that suggested that long-haul

long covid is caused by vascular

inflammation

you know and and the fact that vascular

inflammation you know happens all over

the body

um is really a unifying hypothesis

that brings together you know the 215

plus different symptoms

that these long-haulers experience now

the

sequel to that paper which we just

submitted

uh this morning to the pre-print service

uh really showed that it's because

uh non-classical monocytes

carry covid s1 protein

up 15 months after

diagnosis these cells bind to

blood vessel walls and endothelial cells

through a fractal kind and the fractal

kind receptor that's expressed on

non-classical

monocytes and causes inflammation and

these cells can cross the blood brain

barrier of course

and cause vascular inflammation in in

the brain

the most exciting thing that we found um

in the literature uh and i have to um

throw kudos to dr yogendra on this one

uh is that uh these non-classical

monocytes

are mobilized by exercise

and activity and so here you have a cell

carrying

covet protein and no rna by the way we

just

had a first round of um sorting

experiments

and next gen sequencing uh

today as a matter of fact to show that

there really isn't any um protein in

these cells yet they express the s1

protein

but they are mobilized by exercise

and so of course we to a person

who's a long hauler they get worse

after activity worse after exercise

we've had individuals who've

gotten back to pre-covet levels and and

some individuals who were just

absolutely bedridden who felt well

enough to

you know to work in the yard and take

their kids to

sporting events that overdid it and

um you know had a relapse and the fact

is you know if these cells

still contain s1 protein are still

circulating

a little bit of exercise um you know

more than

just a mile or two walk uh they're

they're going to get a

a flare up of their of their symptoms

and that's why you see this

waxing and waning and when we talk about

therapy in

our therapeutic approach um

we'll talk about how that can mitigate

these flares and and and help eliminate

these cells from the circulation

that is an important point and i'm going

to very quickly

if you don't mind this is such an

important topic

and the i think

i just want to very quickly show this

that so cool means if this is a blood

vessel

and there are endothelial cells here

dr patterson is talking about monocytes

that are sitting near the blood vessel

wall

and they are patrolling the blood vessel

boundaries they actually patrol

all boundaries and one important one is

the blood vessel boundary and they are

in an

m2 state or as dr peterson said

non-classical state that means they are

sort of in a eat and repair state

and then so uh dr so bruce

do they have s1 protein in them or are

they just

expressing it yes they have they have s

they are exp they are antigen presenting

cells

basically and so they are um

essentially doing what they're supposed

to be doing which is presenting

foreign antigens and so um yes there's a

s1 proteins on the surface which we

showed by flow cytometry

then we sorted those cells and again

i'll show a couple slides in a moment

and confirmed using high sensitivity

mass spectrometry

that these cells had a single spike

um spike in the mass spec

uh lingo that showed that it was indeed

s1 protein and and what they do

is you know as you mentioned m2

phenotype

it's a pro-inflammatory phenotype so

these cells are still making tnf alpha

and what's very interesting which i'll

show in a slide in a moment

is that when they when these monocytes

bind to

the endothelial cells through fractal

kine

and the fractal kine receptor they

produce

vegf which we see elevated in almost

all long haulers

and they cause vasodilation

why is that important because i'm sure

you've seen this

uh dr bean is that they'll complain of

a fullness in their head and and

dilated blood vessels and

and headaches and migraines which we all

know are caused from

vasodilation not vasoconstriction

so once again there's there's there's

very little we can't explain now that we

understand

this mechanism that's at play in the

long haulers

this is so important even this morning

and yesterday i was speaking with a

patient

young woman 25 years old and she kept

saying it seems like i have pressure in

my head

and i cannot see correctly and i

become confused and if i go out and look

at the bright lights or

or computer screen i start my vision

does

weird things that's how she described it

so are these related to the issue here

wizard dilatation absolutely and um

you know uh i'll pull up uh a couple of

slides now and show

um the cool beans what um uh some of our

data and what we're talking about

um uh i hope you can all see this screen

um this plot

really shows on the far left this these

are classical monocytes

the cd14 high cd16 negative monocytes

they have absolutely no um uh

s1 protein which is interesting because

as we say in the paper

classical monocytes express very high

levels of the ace2 receptor

and almost no ccr5

intermediate monocytes express very high

levels of ccr5

and high levels of ace2 receptors yet

maybe

uh you know occasional uh infection of

of these cells in both the severe uh and

the long hauler

patients but it's really over here on

the far right

when you look at the non-classical

monocytes

which express no h2 receptor

they express ccr5 and they express

high levels of the fractal kind receptor

and that's where you're seeing all the

s1

positive cells in these

individuals now this is the mass spec

analysis

it's it's rather small but it's in the

new paper

but this top panel here this top

rectangle

shows this single spike in this blue box

that's store-bought s1 protein

we bought it from a company it's highly

purified

it's it's it's the full length

s1 protein and if you look at these next

six panels every single one of these

long haulers between 12 and 15 months

has the identical spike which

represents the s1 protein and if you

look over here

in these two graphs which are

representative of

you know of the specific sequence

of amino acid that uh is 40 percent

analogous um to the spike

i mean 40 of the spike one uh

protein so we confirmed by two different

technologies

uh that these non-classical monocytes

uh are carrying uh the s1 protein

also we went back and looked at the s1

protein

in the cells the cd14 positive

uh cd14 low cd16 positive

s1 protein positive cells

and guess what they're expressing

cx3 cr1 um

which is the fractal kind receptor

and of course that is what allows them

to bind to

uh the vascular epithelium

which this isn't as good as your diagram

dr bean but it shows just the propensity

of of these three monocyte subsets

and their functions the classical

monocytes phagocytosis

the intermediate monocytes

antigen presentation regulation of

apoptosis

trans endothelial migration

and then of course the non-classical uh

monocytes which as you suggested

their function is to patrol the blood

vessels

uh they are also phagocytic and they

also present

uh antigen which is exactly what's

causing

all the vascular inflammation in long

covid

as you can see here on the closer up

these cells bind through

fractal kind and the fractal kind

receptor

and in the process produce a th1

response

which as the cool beans know the th1

response is a

classical antiviral response that

consists of interferon gamma and

interleukin-2

well you know what goes into our

long-haul or index

interferon gamma levels and il-2

divided by cxcl4 which is of course a

ligand

for ccr5 but it

we didn't know this when we were coming

up with the algorithm or the computer

was helping us come up with the

long-haul or index but when we started

looking at the mechanism

that causes long haulers we found

amazing correlation with what we had

published last week in terms of

the bioinformatics and the vascular

inflammation

theory and then again over here you see

when

these vascular monocytes bind to

the endothelial cells through

cx3 cr1 which is the fractal kind

receptor

and fractal kine which is another name

for it is cx3

cl1 messenger rna what does it do

promotes angiogenesis through vegf

and it causes vasodilation which of

course

accounts for this head fullness

headaches

migraines etc maybe even the brain fog

and so um why is that important well

these monocytes express ccr5

and they're mobilized by exercise and so

from a therapeutic standpoint

we recommend ccr5 antagonists

we've been using moravarak laurentlimab

is another example that's been talked

about on this show a lot

it's another ccr5 antagonist is still

awaiting

uh approval but they are critical

in keeping these monocytes from

migrating

all over the body in response to ranties

and people always say i talk about

ranties all the time well you know what

in the long haulers ranty's is elevated

and over 80 percent

of long haulers so we still have a

rante's driven disease and in fact in

one long hauler

uh last week their ranty's level was

900 000 when normal is 10 thousand

and the highest we saw in our first

studies of acute covid back

in february 2020 in severely critical

patients was three hundred thousand so

at times the levels of

ranties in long haulers is even higher

than

uh the most severe cases of acute covet

and then effect in fact the angiogenesis

and vasodilatation

play a part but we can also interrupt

uh this fractal kind fractal kind

receptor

uh pathway with statins

so the hallmark of our treatment regimen

now

um that we recommend is a ccr5

antagonist

and statins and of course uh ivermectin

we have found

uh as as you've used extensively and

and dr corey as well we find it to be

very very useful

in our combinations uh we tend not to

use it uh

alone because now that we understand the

mechanism

behind long covid um

we want to interrupt the pathway we want

to treat the cause

and not the symptoms but by no stretch

of the imagination

do we think that ivermectin isn't

important in its immunomodulatory

effects

that complements uh the ccr5 antagonists

uh and fractal kind and excited

i'll go go ahead i have a couple of very

important questions so i don't want to

break your stream of thought so please

complete your thought and i would

ask the questions yes i just i want to

uh show one last slide and i'm excited

to get back to the questions because

this has been such

a key question uh out there in

social media and and from our patients

and that is the post-vaccination uh

long-haulers or the the people who have

never had covid

um and three or four months after

vaccination they have long

hauler symptoms well i think we've

enrolled

um you know a hundred or maybe even

close to 200 now

and we're starting to input the data

into our machine learning

algorithm and we had fascinating results

from the first

20 or 25 that we fed into the machine

learning

where we saw a very heterogeneous group

there was one individual who was normal

by the severity score which we use in

acute covid

and negative by the long hauler square

which we use in long haulers

we found four um

individuals who had a uh

inflammatory profile that looked a lot

like

um covid and severe active covet

although it wasn't and then the rest

look exactly like long haulers from the

long hauler index

so and then we went to a binary

uh bioinformatics models they all

uh qualified as long haulers so

indeed immunologically they resemble

very much like long haulers we've

treated them as such

and we've been very successful in

treating them so as much as it's

a side effect of vaccines i think it's

not something to

be too concerned about it's treatable

um and uh it's not something that will

that will stick for forever so we're

very pleased to um

to take a look at that so that is

excellent i actually have a question on

one of your slides as well but let me

ask a few questions that are

even burning questions for me too so

first

question reema are these monocytes or

macrophages

they are monocytes and you know there's

been some reports that

macrophages in the gut it's and in the

lungs on autopsy contain

um you know covalent sars and i i don't

i don't doubt that um that's just

a part and parcel to the fact that

macrophages

function in the tissues they're gonna

have um

residual um virus i don't think it's

replicating

the the the key point about our

discovery

is it's in a highly mobile

cell that's in the blood they are true

monocytes um non-classical monocytes but

monocytes nevertheless

and they have the capacity to go all

over your body

and cause inflammation and that is what

is

so key about this finding relative

just uh to autopsy findings where you're

going to find

you know bits and pieces of virus and

you know in

terminally differentiated uh macrophages

thank you very much i want to share a

thought with the with the cool beans

cool beans for the today's talk i was

thinking that

the whole world population became stuck

with this

covet seven billion and more people

and then there are people who invented

divermectin or discovered it

and now they're they are not but there

are people who are pushing it like dr

pierre corey they are the people who are

saving

billions of people similarly vaccines

are actually saving billions as well

and i was thinking about dr bruce

patterson and his discovery

it is at the same level of saving

billions of people because this misery

i can tell you today while talking with

one of the patients i was so

angry he he has post-covered

long-haul and he himself is a research

worker and a health care professional

and he goes to doctors he knows them he

himself is a healthcare

professional and he's a research worker

and he goes to doctors and they have no

idea

and when he says we should try this or

we should test that they have no idea

and they have no

other than a few they have no even

interest

and i was becoming so angry to say if

this is what vaccines are going to do

and then we are going to break people

and then we have no help for them

then what is really the help there so

once again thank you very much for your

work

i wish everyone in the world can once

know that there is

a team that has discovered it and they

have a solution

and be able to use that now there is

another

question here which is important simple

garden says

will the system eventually equalize and

return to normal

that's you know these are just the the

the best questions that get to the heart

of the matter

and the fact is these cells have a

definitive lifespan

and you know if you look at classical

monocytes

intermediate monocytes and non-classical

monocytes

in normal human beings you're talking

about you know

life spans in the order of days and

weeks

what happens though in pathologic

conditions

is uh a whole set of mechanisms

that prevent cell death

come into play that make them more

long-lived

than in normal individuals that said

using the combination of ccr5

antagonists and

and statins and ivermectin

we've seen by doing serial monitoring of

these cells

we've seen the levels go down so we

are very very hopeful and optimistic

that eventually these cells get cleared

we are

we've already shown people in

patients in our program that we've

gotten their immune systems back to

normal

absolute normal every one of the 14 plex

cytokines in our panel is normal and

you know that was the goal you know

restore the immune system

to normalcy you know sometimes there's a

lag in the symptoms

but and then also there's there's

symptoms that just

are a function of being debilitated for

12 months

i mean if you broke your hip and and you

were laid up on the sofa

for eight months and all of a sudden

your hip was better

you know you would have aches and pains

and be out of shape and not be able to

do what you used to do and have

have fatigue um so i think it's

reassuring that we can say to these

individuals

hey your your immune profile is back to

normal

um usually their their symptoms are

right along with that

um but some may have some symptoms that

remain and

so we get them to 90 to 95 percent

of their pre-covet levels and we still

have five to ten percent to go but i

think that five

to ten percent is a function of being

debilitated for so long

and maybe just normal effects of being

sedentary or even you know bedridden for

so long

that we have to start stepping up their

exercise now that we've

you know eliminated these these cells

stepping up their activity

um and um getting them back to you know

getting them back to a normal life

there may be setbacks but what i tell

them is

we were able to get your immune system

back to normal we have a target like a

like a bow and arrow um we know

where the bullseye is and we know how to

get you back there so go ahead

you know we'll step up your exercise

go get vaccinated if you want to get

vaccinated

um we'll deal with the consequences

of increased activity and other

perturbations

of the immune system because we know how

to get you back to where you were

and that's our message got it thank you

very much

i want to ask one more question on the

pathology side and then we have tons of

questions

uh so on the pathology i want to share

my screen for one more second and i have

a question

uh so number one correction i wrote

fractal coin it is fractal

fraction yes

i think i spelled it five different ways

while i was writing the paper

thank you very much so the question that

i have is you you mentioned interferon

gamma as well

so we know that interferon gamma cool

beans are aware of a diagram where

we have t helper 2 pathway and p helper

1 pathway

and then t helper 1 this is naive t cell

and then we have cytotoxic t cells and

we know that the t helper one side

produces the

interferon gamma how does interferon

gamma affect them

is that the what you have discovered

that interferon gamma then effects them

and activates them

or the other way around that is the

piece i didn't catch

yeah i believe it's the other way around

and um

and it's being produced by them i mean

these these monocytes still have

pro-inflammatory properties

so they're making the tnf and they're

making you know other

other cytokines in some cases uh il-6

and

you know um and and the fact is

we we have all those in our panel so

we that's allowed us to put together the

mechanisms that you just elegantly

uh drew out and we can monitor so we

know

interferon gamma is part of this process

we know vegf is part of this process

we know that io2 is just going to be

upregulated because they are trying to

fight off

what they the immune system perceives as

a viral infection

so of course il-2 is going to come along

with interferon gamma

and of course those are the numerator of

our long hauler index

so by by therapies you know we should be

lowering the numerator of our long or

index and of course bringing the

long-haul or index

down to normal levels that's the beauty

of having

precision medicine and and having a

non-subjective

measure which turns out is very much a

part

uh of the pathogenesis got it okay so

essentially what you're doing is that

you are telling these guys

to stop and one is that you're breaking

their connection with the endothelial

cells

and the second is then you're trying to

convert them as as well to better cells

or die off

correct yeah i love it we're trying to

reverse the

the program uh that is involved in

them uh uh preventing

them from dying off so we try and you

know obviously i think the ccr5

antagonists are

are um you know are very much involved

in that as well

so so cool means what is happening is

it's just my excitement and excitement

for uh for a therapy that makes so much

sense

that we are saying that hey these cells

continue to live on

and they're bothering the system as well

they're creating cytokines they're

causing

vasculitis and all those symptoms

and we want them number one to stop

doing it in the immediate

and then we want them to either die off

or converted to some other form

so that is that is genius so thank you

very much for

uh doing this uh dr petterson uh bruce

i'm gonna ask more questions now

this is just so so exciting so caitlyn

says what about reactivated viruses due

to covet is there a treatment that can

help

so slightly different do you have a

comment about this question

yes because um a lot of um

uh long haulers as you know

have chronic other chronic viral

infections ebv

cmv uh varicella hgv6

etc they're herpes family viruses

and so there isn't reactivation

uh of covid because you know as we said

you know it's just protein there is no

rna

as as much as we can find and um

you know we're going to great lengths to

we have gone to great lengths to find

that

um but you know uh so they don't have

this true latent

phase like herpes family viruses

that tend to lay dormant reactivate

lay dormant reactivate you know and

that's all part of

you know chronic fatigue syndrome and

you know and

and some of these other more chronic

post viral

infectious syndromes where they live

along they live for years

but they're you know uh sarsko v2 just

doesn't have

you know that capacity so you know

eventually they'll be eliminated

as we discussed in our paper it's very

much like borrelia

which is the pathogen responsible for

post lime

um fascinating that that

that post-lime involves these

intermediate um and possibly these

non-classical

monocytes because it sheds its

uh basically the cell wall the bacteria

remains

and gets phagocytized by these monocytes

but there's no there's no active

bacterial uh

replication going on yet we have a very

similar

um you know symptom set uh in post

lyme so we think that our strategies

that we've deployed for a long covid

will

uh apply for post lime fibromyalgia

chronic fatigue um and you know

we're actively pursuing that now because

we want i think we're able now to say

uh let's see how closely it resembles it

much like we did with the post

vaccination group that are covet

negative

we wanted to use our machine learning

and say well

where did they fall are they long

haulers are they active coveted are they

some

unique category on their own and like i

said we just

you know at least on the planet

preliminary data

see that they're very much like long

haulers and

not not so much like uh active copy but

you know uh if i was a betting person i

would put my money on the fact that

there is no replicating virus

um left in uh long haulers

at least especially after you know say

eight to ten months i mean we found

covet rna out to uh nine you know three

months

maybe four or five months and we we

published that last fall but

um i think we're looking at 12 15 months

it's be hard-pressed to find virus

love it thank you very much for this um

and please

don't mind luffy is here as well and

he is an admirer of your team's work as

well

so he's just chiming in so some more

questions uh

so in your protocol i believe that you

have maravaroc

agromectin statins aspirin

luvox so uh muravarak

so how do you target this state through

miravra for example

well again these uh non-classical um

monocytes are expressing ccr5 and

you know much like bees are attracted to

honey

you know these immune cells are going to

be attracted to ranties

and we already showed in our first paper

that rantes was statistically

significantly

elevated in long haulers compared to

severe mild to moderate and um

and normal uh individuals so again

ranti's is playing a role in long covid

um it's made by activated platelets

which are probably responding on the

you know the inflamed uh you know epi

endothelium

so you know it you can really if i could

draw as well as you do dr bean i could

probably

put it all together but um i just

haven't gotten down to

um you know laying it all out on a piece

of paper or a white board

like you so elegant so why not i come

visit you and you just tell me what to

draw in a drawer on a white it's a

scanning invitation

perfect i'll be over uh so then

if we continue with the next part of the

questions

you have been i believe in the us

and that would mean in the world as well

your team has managed

the most long-haul patients tell me this

how soon

they start becoming they start feeling

better

yeah it's that's a great question by the

way we we just did a pilot study in the

uk

we're um negotiating with a lab there

we're

already on our way to a um validating

the assays

in um in a lab group that's based in

spain but they have labs all over the eu

so um we are rapidly expanding and we're

scaling

we're bringing on three more um

physicians

uh into the uh coveted longhaulers.com

group and then we have a hundred over a

hundred network

physicians that that we work with to

actually write the prescriptions and

manage the patients so

um we are just aggressively

scaling right now in terms of um what we

look for

is um we we start

we we go at two week intervals and we

want to see some improvement in two

weeks

and we really truly believe that we you

know for the most part for the majority

of the patients we do see

some improvement at two weeks um

do they get all the way to ninety

percent in two weeks no

um do they get some get to seventy

percent or eighty percent

yes um and then we'll go another two

weeks

to four weeks um and then

we'll continue to see improvement and

then we repeat the labs to see if we've

restored their immune system to normalcy

so i would say on average uh four to six

weeks

and we're starting to get people really

um

back to you know their normal lives and

you know with some with maybe some

residual

symptoms which we really think are just

part and parcel to being debilitated

and again we have that we have the

precision medicine to say that their

immune system has been restored

and that's really what our goal is

got it sorry i actually i mute myself

that is why

so the next question so hello dr b dr

patterson

have you found any relationship between

covert long haul

and herb w envelope expression in teal

info

sites oh my god i never thought

um someone would bring up a retroviral

past

of mine in a single question with long

covid

um of course the answer to that is no

but i

love this question and thank you for

asking me because

you know one of the questions i get

asked is oh are there they're

um hiv or retroviral sequences in the

covid genome and uh my response is

we have retrovirus like sequences

in our genome they're called herbs human

endogenous retrovirus are viral

sequences

so um you know i i

i love that question i haven't looked at

frankly i don't have time

um i'm not you know i i left my

academic hat a long time ago uh i'm

running a company

and um yeah i'm i'm pushing the basic

science behind it but i just don't have

time to

to look at every really cool question

like you just raised

got it one more question

post vaccines how does

so we established that this is happening

to post vaccine as well

how is the vaccine ending up causing

this

well that we're looking into i mean

there's there's one thing that's

um that we see that's different from

long covet and that is the extr the

elevations of um vascular uh

inflammation markers so the long-haul or

index which

which i said is il-2 plus interferon

gamma over ccl4

um that's elevated which makes them you

know in our book

uh a long hauler um but

we don't see the elevations in in veg f

which is great because that causes uh

peripheral neuropathy

i think it's the responsible for the

brain fog because it reflects as you

just as i showed my slide you

you drew out um you know those cells

cross the blood brain barrier and

cause this fullness and vegf expression

there and and vasodilatation which of

course

is probably the heart of a headache and

and migraines

but um we just don't see that that the

most common pattern we see

in um in uh in

post vaccination uh long-haul or

symptoms

is uh ranty's ccl5

plus soluble cd40 ligand

in addition to elevations in the long

hauler index

got it and one more time

where we are going to look we're we're

going to look in these um

uh in these monocytic subsets to

see in the post vaccination individuals

if

if they're still uh harboring you know

fragments of

of covet protein um you know three and

four months after

uh after vaccination

so one more time hold beans who are here

i'm i'm seeing about

1300 people who are watching right now

uh

this is dr patterson's uh company's

website once again i have no association

no commercial interest my interest is

i'm grateful to bruce i'm grateful to

his team

he's here he's talking he's providing

information

needed information uh it creates hope it

creates it saves life i

know long haulers who have been told me

that i want to die

and so here here is a company that can

help

this is his website

coveredlonghaulers.com

so please if you are if you are in need

of

help here please connect with them i

want to

continue to also share that this is the

long haul protocol where dr petterson's

team

has input as well this is on flccc site

so having said that we're talking about

long-hauling which could be because

of the covet or because of the vaccine

so next question uh dr peterson

how do you know that this was s1 was

that where was the s2 so

this is the biggest thing so you know

that this is s1 fine

where did the s2 go it's a good question

um you know i think part of it was

um you know we found the s1 protein

um we are in the midst of doing

you know even more protein sequencing to

see what else is there

but um we our goal was

you know the fact that we found it by

flow cytometry using high parameter

flow cytometry where we were able to

label uh

cells with 20 different antibodies

including the

an antibody against s1 protein and then

sort those cells and and you know our

our

singular goal was to confirm that indeed

um there was s1 protein in these

non-classical monocytes

that is not the end of our journey

trying to figure out

exactly you know what is there are there

other fragments that could be

stimulating the immune system as well

and it and again like i said we've

already sorted those cells

uh again and purified the rna for

next-gen sequencing

uh to look at the full complement

of um of sars code v2

um rna and and that would be multiple

genes in addition to

uh s1 um and you know so far

we haven't found any but we're we're

doing a another set of experiments here

in the next few days

got it all right so the next question

prima

is there a pattern establishing

potential

post wax long color who is likely to

have hyper reaction this is

one of the most common question for me

as well that folks ask me

do we know who will develop severe covet

do we know who would become a long

hauler post covert post wax

do you have any clue from the

research you've done so far yeah so so

what was very interesting was in the um

the paper we just submitted is we used

some severe codes as

controls and in fact we saw uh this

monocytic reservoir being established

in active covid and um

because but but they were also those

cells were also

um you know more likely to be rna

positive

and um s1 positive

now in terms of the post-vacs

we're we're basically going down the

exact same path and

the part of the path that we're at right

now is we've already

done the um immune profiling in terms of

soluble mediators cytokines chemokines

etc

and the next step for us of course is to

then look for

you know s1 protein which is you know

what's what's

what we're vaccinated against and um

look at that in the different subsets of

monocytes in that group

but we have data that suggests that

long haulers are established

at the time of infection and for me

uh having been involved since you know

january 2020

we got into a situation where i don't

think uh individuals were treated long

enough

and or and or treated with steroids

which yes from the pathology standpoint

prevented tissue damage from the

virologic standpoint

maybe not so good because it allowed you

know reservoirs to be

you know to be established so you know

everything's a

risk benefit um and but i do think

what brought down the specificity of our

long hauler index to you know 93 percent

or something

still great was that several of the

severe

coveted individuals that were in the

study that was published last week

actually had a long hauler index meaning

they were on their way to becoming

at least immunologically a hauler

and they still had active coping the

rest of active cover we

we didn't see any signal in the long

hauler index

but there was a few and we really think

that that's established

at the time of infection um and it's all

about reservoirs

and tropism and um

you know we are just starting on our

journey with the

the postbacks long haulers to see if

it's something similar

or if it's something different or is it

just something that

you know um like we've seen some mild

therapy and

it goes away so um you know as much as

it we don't want to see that

it's we can diagnose it and we can

manage it

and we can follow it now with the

long-haul or index

got it two questions that are in my mind

then i'm going to go to a question

you can look at the question now and

maybe respond to it later

there is some doctor yo over here i have

no idea who he is

so doctor you are saying is it true that

dr

p is born his name

[Laughter]

oh that's funny um you know

uh maybe maybe someday okay

so i have a question about tinnitus

many of the post vaccine patients

are experiencing tinnitus as well post

covet as well

what is the relationship of tinnitus

with this mechanism

i mean we very

often see tinnitus with brain fog

and um what is really

miraculous is that with i would say

within three to five days tinnitus is

gone with a ccr5 antagonist

um which is brilliant because it's

really bothersome to a lot of people

um and i and i wonder i'm just thinking

that

preventing the migration of cells at

least in long haulers

uh into the brain um

and keeping them from the vasodilation

which i think

tonight is probably uh a part and parcel

with

vasodilation and and increase pressure

um in you know in certain parts of the

certain parts of the brain but you know

we see it a lot

we've treated it a lot and i think we're

very good at

eliminating it and that is a very

important point

my worry has been that

with the long haulers when there is a

continuous

inflammation going on and now we know

thanks to your

work that it is at the boundaries of the

blood vessels and vasculitis is

occurring

there could be damage if this continues

on for a longer period of time

because it will be scarring on top of

the damage

and that can become a permanent issue so

that means managing this

as fast as possible is important

even when we say here we are sitting

here and saying it is possible that in

some months the patient would gradually

continue to become better

i feel it is important for them to get

better as fast as possible

so that the damage and the repair

is not that extensive that the blood

vessels and the areas are just

just gone they're scarred am

i don't disagree with that and i think

um you know

you made a really good point i mean and

in fact the immune system

uh and tissues have amazing capacity to

repair

and number one repolarizing macrophages

like we

talked about in acute covid with the

ccr5 antagonists

by crosslinking

ccr5 you uh you can

convert and repolarize macrophages from

the

uh inflammatory pro-inflammatory m2

phenotype to m1 more effector

reparative phenotype um and i think

all of those are very important but i do

think like in any disease

the earlier is treatment the better the

sooner you get on this the better

um and you know it's it's it's sad that

it's taken us this long to really

recognize

long covid and um and start treating

aggressively

and um you know we we saw in the

in last june we started working on it

aggressively

and we're in a really good place right

now

but to think that people suffered

for so long is really

like i've said in many reports gut

wrenching i hear it every day

we we now get like you said probably

have the biggest cohort of long haulers

uh if not in the united states maybe in

the world um

and we've heard so many stories and

seen so many different manifestations

it's uh

you know we're we're trying everything

we can we uh i think we've

uh we've we've gotten reimbursement now

for

some of our testing um we're in other

countries

uh we're talking to congressmen and

people in the in the government to

push for benefits for these individuals

who may be out of work they've certainly

been debilitated

but another there doesn't there's not a

day that goes by

where we not only do we think about

mechanisms and what's behind all that

that we think about

what can we do who can we talk to

to get these patients taken care of um

because the economic hardship um

of long covid is mind-boggling

if as as we all think could be ten to

thirty percent of everybody who's been

infected this is not going away in

two years three years maybe even five

years

so um we really have to think about

um you know benefits and and helping

these individuals

in india monocytes will have a lifespan

of around 24 hours

if i'm not wrong would new monocytes

also have the spikes within

um that's a good point uh we addressed

it in

our paper obviously yes they have a

24-hour life span

normally but there's nothing about this

that is normal

um and like we said and we wrote out in

our paper

there are um reasons why these

monocytes are are long longer lived

we do think that eventually they will um

they will die off

um but yeah they're they're longer lived

because impact that's what happens in

pathologic conditions

so um yeah no if you look in the

literature you're absolutely right

you know classical mass 24 hours here

you know

the non-classicals the you know the

dogma is

they have a weak lifespan but again

you're talking about normal individuals

and i'm going to show a comment it's not

a question

but this is what i'm seeing many

neurologists doing

and check this comment out sylvia says i

have a friend who has been a few

too few neurologists and they do not

know how to help her

she has been getting headaches for six

months she has gotten shorts behind her

eyes in her optic nerve

she's an rn i know that some

neurologists have been

offering patients shorts through their

ears for steroids and so on

this is this is just so sad uh

what is the right thing just the

protocol that you have

that is the one even after six months

that should help

yeah absolutely and and you know what

and and

and and thankfully you know we all

collaborated on the flccc

protocol which i think uh has

significant benefits as well

um you know we need to tackle this thing

before

and and yes there is a lot of shopping

for the quote quick fix

and um some of the things i've heard you

know

stem cells and um you know

you know uh exosomes and you know it's

just

mind-boggling what is out there um

to try and these people to get better

and

um you know it's not

you know it's it's just about looking at

enough of these individuals and looking

at the disease and digging deep

to figure out what what's going on and

you know obviously we have our

you know our our bent on on the whole

situation

but my my advice would be to avoid

any invasive um procedures at this point

unless you have some uh underlying

condition

on top of got it thank you very much

uh two more questions there is one here

from

site two three six zero anyone had

success with the protocol

[Music]

many i mean we wouldn't be doing the

protocol if it wasn't successful

so yes many many many many i mean

yeah i can probably count on my hand the

number of individuals

that um haven't responded

and a lot of times they have

many many other underlying conditions

and so

you're faced with this balancing act of

trying to treat the long-haul or

symptoms but get but they've got x

y z you know whether it be you know

lupus or

some other things and you know um

there's there's some extremely

complicated

patients that we've come across that um

either we've said

we we can't recommend

treatment until you figure out what's

going on with your underlying conditions

um we will advise them that you know

yeah

there's you could have low cd8 counts

we've seen that 25 percent long

haul or so maybe your immune system

you're slightly immunosuppressed

although part of your immense immune

system is hyper immune

i mean we try and give them as much

information as they can but

there's some that just have so many

things going on that um

you know it's difficult to sort through

them all

got it all right next question brandon

andrade says is it common long haulers

post wax or post

covered with chronic dysphagia

and how are you treating those cases how

long does it take to recover

on average you know we haven't seen

a lot of chronic dysphagia we've seen

some

and again you know we don't know if

that's over

stimulation of the vagus nerve or

neuropathy because of vegf

[Music]

typically what we do or sometimes they

feel this strap this tightness of these

strap muscles which i think is is just

uh you know

inflammation or maybe even a little bit

of myositis

um again we just stay the course we're

going to treat the underlying cause

and we're going to see these these

symptoms go away

and if they remain after we restore

their immune system back to normal

then we'll go looking for other other

causes

just a comment here beth bauer says dr

bean i was better in one day one day

so once again thank you very much bruce

for your work and your team's work

emily vegan says how long is maravarak

prescribed for

well again you know we start at two

weeks we go to four weeks

um and um you know

i think that's that's where we that's

where we end up with

you know a very good response and you

know normal

close to normalcy in the immune system

if not if not normal

you know and everyone talks about the

the toxicity of murabarak and

we have two papers um posted on our

website

one on the by the nih uh the

safety of maravarock um over five

years in hiv patients who take it every

day

um and then we have another paper um

showing the safety of maravarak in the

pediatric

population and you know what

nothing says safety like

safety in the pediatric population and

since you're on

you know there there's the pediatric

paper if you're on it for

you know two weeks maybe four weeks at

the uh

outside you know longest is probably six

weeks you know

you're and we monitor you know liver

enzymes just to be

ultra cautious but you know we don't see

uh we we've seen two liver enzyme

elevations

in individuals who took tylenol

and zero in maravarak so it's tylenol ii

moravarak zero so far but um

those are the two papers right there

that um are on our website if anyone

wants to read about the

the safety profile got it thank you

pro tool 44 says would long haulers be

affected by micro rna dysregulation

again you know what there's only so many

hours in the day

um you know we um don't have the luxury

of you know looking at all the the

questions we want to

look at so no we haven't we haven't

looked at that one

got it all right

so that's an interesting question uh

totally up to you if you

want to pass on it but the interest

question is interesting so tara

ab123 says will the muscle cells in the

deltoid be replaced after being targeted

by

immune response due to vaccination that

is if they took up the antigen and

they're presenting the antigen and the

immune system cells comes and kill them

would these cells be replaced or what

happens

well the good news is muscle cells um

you know

uh can recover i mean they're not

um but i have no idea i just

i just haven't looked at that got it

i want to ask you one more question from

my side here

uh two things one i wanna understand

what is the future of your program how

do you continue to scale up

one request in this questions context

that i'll make to cool beans and cool

means you know that i have never tried

to

push you to do something i say a

customary request

to share like subscribe i think this is

one of the

videos that if we all get together and

we share it to as many people as we can

it has saving lives is another thing

here it is saving misery saving from

financial disasters

saving even even from suicides so please

share it as much and my question to dr

uh paterson what is the future of your

program number one

and number two what is immunotrack app

yeah great great questions and um

you know it's the the program

again we're already expanding uh around

the world we're

we're into you know getting into uk the

eu

central america um and uh

south america uh potentially into

asia at some point so yeah we're

expanding there

um you know the great thing is we can

scale up the manufacture of our

um our test kits uh quite easily

we're now scaling the telemedicine but

we are super excited about the

immunotrac

app and the immuno watch that we just

got our first shipment and so

um the app should be live in in you know

about two to three weeks

it's already been accepted i'm pleased

to announce uh

for the app store on apple it'll run off

apple it'll run off

android and it will run off our specific

watch

and you'll be able to

score your own symptoms track

heart rate blood pressure

o2 and heart rate variability

over time you'll be able to upload your

labs

you'll be able to upload your

medications

and then the physicians will have a

dashboard

where they can say well i change

medication on this day

look at what happened with the symptoms

scores look at what happened with the um

the the the heart rate with the heart

rate variability

o2 bp everything and see

see this dynamic going on in these

individuals

then ultimately what we want to do is

apply bioinformatics

to all the data that we're collecting

along with the immuno watch data

to provide even better algorithms for

prediction

and as i said in the beginning we are

aggressively going to expand

into chronic fatigue post lyme

fibromyalgia other immune based

[Music]

conditions uh in addition to long

haulers because

once we've established the model i think

we'll we'll keep moving forward

in in the immunology space and then the

best part

about what we offer at insole dx is the

ability

to provide basic science research that

drives that engine that results in

precision medicine and better health

care

got it thank you very much good luck and

totally deserved for the work that you

have done

i am really excited that after the

covered long haul and vaccine long haul

you're now moving towards the chronic

fatigue and post lime

because those patients have been

suffering for decades

without much help exactly so

anthony karalika says reactivation of

non-viral pathogen

many findings tick-borne brilia

bartonella

babassia and mold toxicity

all previously harbored but at bay

before c19

immune wreckage symptoms all the same as

long haulers you touched upon that a

little bit before as well

yeah agreed and that's you know um

the pathogenesis can even be similar for

instance

you know like i said borrelia there's no

sign of

of the bacterial nucleic acids

but the the the cell wall proteins

are are being phagocytized by

intermediate and non-classical monocytes

and just like we just presented

are being presented to the immune system

in these

individuals and and probably causing the

same vascular

inflammation and and thus the same

symptom complex

don moonslander says does suspect ii

have to enter bloodstream

in order to express s1 on monocytes

no because they they patrol

um you know they patrol the blood they

patrol

uh for you know um you know these

dime cells they patrol um you know

most of the body for that part and um

not to mention in our first paper from

last february we were actually the first

to report

um plasma viral load with sars cov2

it's there we had to use uh droplet

digital pcr

which is extremely sensitive and used

for looking at cell-free

dna and cancer so that's how sensitive

it is and

we found virus and plasma mostly in

severe

cases but indeed you know there there is

virus

uh in plasma we don't know if it's you

know like everything else we don't know

if it's replicating

but um we found it so we got it

this is an important question denise

says how about

mcas folks sure

you know we'll take a look that might

require some additional markers

i mean you know it's conceivable that

you know our our current panel and we

have the capacity

to add to it um and as we go

to each of these new frontiers if you

will

um we may have to add additional markers

like

much like we would with mcas

frisco coupon says dr patterson what are

the three top things

institutions can do to improve their

relationship and trust

with the society which i think quite

quite a damaged trust at this time yeah

you know

i think um number one this

this pandemic's been a huge challenge

and um

you know the management of it is is

difficult because there was a lot of

things that were unexpected

but um you know i think

really in the future we have to have a

plan

for emerging pathogens i've said this

for a long time

we have to stockpile drugs that are

immune modulators and

and and drugs that um

like ccr5 antagonists where you can

enhance the immune system

in a non-pathogen specific way uh

and there's of course other drugs that

you could do that but

i think part of the problem is we were

just

caught flat-footed um with this pandemic

and then when that you know when we saw

you know a year ago you know i i came

out in march i think in 2020 said

you know when i looked at the mutation

rate i said we're gonna have a problem

you know and and this came from my hiv

days i mean we're gonna have a problem

once we come up with pathogens

pathogen-specific therapies

neutralizing antibodies vaccines etc

virus is going to fight back

and that's what it's doing right now

it's fighting back with with variants

and you know what the variants are going

to emerge and then we're going to be in

a race

against the variance but we have to come

up with

a strategy that involves

non-pathogen specific therapies

and that we know from cancer in the pd1

pdl one story that we can

we can fight off foreign invaders

whether it's cancer

or virally infected cells

in a way that's not specific for that

particular cancer

or that particular virus or a particular

pathogen by enhancing our immune system

and i think that's got to be the focus

of an ongoing strategy so that

we don't get caught again uh in a

situation like this

got it and please don't mind when i'm

looking around i

am looking at the comments to look for

the next questions

so it's not that i'm ignoring your

message my apologies

so we have jodi virginia's question does

iver mechtin thwart the establishment of

a long haul from wax or

covet with early treatment

i i don't think that's been studied um

frankly and

we don't we don't know

like i said there's some evidence of why

long-haulers become long-haulers at the

acute phase

but um uh you know no one's really

trying to intervene

we're just now reporting what we think

you know

and and you know we'll get on to how can

we prevent it

um and yeah maybe maybe ever mechtin and

combination of ivermectin um

ccr5 antagonists and statins

will be a protocol that can be used

to number one to prevent people from

becoming

severe but number two also be able to

um thwart the establishment of

reservoirs

uh in these cells got it thank you

and just if if i can add my comment this

is not a study

my patients many many hundreds of

patients were covered

a total of three patients became long

haulers

and i have been regularly using

ivermectin my primary use is ivamectin

similarly we have heard from dr hector

carvalho as well he has a latest paper

too

about long hauling and ivermectin so it

seems like there is a benefit

so i think this is great combination

that we have statins and

ivormectin and possibly steroids as well

to help

[Music]

continuing i i think that

this this talk today could be the mic

drop talk because we have now

on dr bean we have talked about the

prophylaxis we have talked about the

management

outpatient management severe management

and now with the long haul post vaccine

and

post covert i think the whole structure

is complete

this is such in such an important talk

thank you very much

once again uh bruce for being here

uh so we have a question from and are

you okay

if i asked a few more questions i know

it is 1 hour 20 minutes

bilal new jersey is there any

individuals who got

free of meds after they got successfully

treated

to 95 okay meaning are there people who

actually helped them we're doing a lot

of that right now

we're um we're basically taking them off

meds and

perturbing their sis like i said what

we're trying to establish is a

is a target like a bow and arrow you

know

we know how to get you back to your

immune system being normal

now what we do is when they get back to

normal we take them off meds

to start slowly increasing their

exercise

and perturbing their system and

knowing that we can go back on the meds

and bring them back down to baseline and

immune normalcy

if if they were to get um

if they were to get worse but yeah

that's exactly

kind of the stage after all these months

that we are in with

our many many patients is that um

we're more and more thinking about okay

what do we do in terms of exercise

like i said some of them want to get

vaccinated and and we say okay

go ahead perturb your system we know

what to do we know how to get you back

so that's that's our philosophy yeah

awesome web access 11 says

me cfs dr bruce please get in touch with

ron davis

whose son is suffering

yeah i've heard that story he was at

stanford when i was there

um i just um you know i

we're just literally every day

i mean working till late hours i just

i just haven't had a chance you know

he knows where to reach me if he wants

to call me that's great but

you know i um i just

from the minute i wake up till i put my

head on

i'm i'm working so thank you

anthony stefano says do we

have any insights into what happens to

the spike proteins

during mitosis can this cause fusion

with dna causing long-term effects even

in the brain

so during a cell division

can a spike protein

fuse with dna or can the messenger rna

fuse with dna

it's a good question you know and it's

just like i said it's just

something we haven't looked at um we

could look at it because

we have the capabilities by flow

cytometry to look at

sequential um generations daughter cells

you know uh daughter cells daughter

cells and see

you know how it gets distributed um

during cell division

but again we're we're out of time

we got it all right so glb says

this is primarily an immune system

disease

and so must be treated

absolutely it's immune disease and it

must be treated as such

you know i think the the virologic phase

went away a long time ago

so yes we are treating an immune disease

this is an important question sorry my

advice is echoing

uh how to fix long-haul loss of smell

two weeks plus

[Music]

again uh i think the one thing we can do

is relieve the inflammation that may be

pressing on

uh the nerves that are um responsible

for smell

um i don't know about you

dr b but i i just don't i don't see a

lot of loss of smell

in our long haulers i mean yes of course

i see them but

it's not when i look at the things that

come up first on the list

obviously still fatigue brain fog

tinnitus um you know arthralgias

arthritis

i mean i just don't see a lot of anosnia

uh anymore uh in long haulers the other

thing i find

really interesting is a lot of long

haulers are from this

march to june 2020 period

you know uh after we've seen thousands

and um you know i haven't polled our

office but

you know when i'm talking to people it's

this march to june 2020

uh time for um you know for these long

haulers

so i'm i'm eventually i'll go back and

look and see

what were we doing in terms of therapy

uh at that time

that may be uh contributing to this

got it just to comment on the

announcement side

what i have seen is that my acute covet

patients

sometimes linger on for a few weeks or

months

with a nosemia and high dose of vomiting

usually

reverses that within a couple of days

so here is a question from rima

what is a product prediction for post

wax long hauler

if it mimics long haul or post covet

could it be as high as 17 percent of

vaccinated people

is there an estimate

again i i don't see that kind of

percentage just by the number of

enrolled in our program um and like i

said uh in the beginning um it's

actually

treated pretty pretty simply and um

tends to go away very quickly

one more question and then we will stop

samantha says

how do you treat patients with fast

heart rates and heart heat intolerance

same way at the heart of it is

excused upon is

inflammation and it's either

inflammation

you know stimulating a response

certainly the heat intolerance is

probably because of the vasodil

dilatation but um i think the heart rate

um when we've seen our patients who are

you're reporting

recovery in all symptoms um they um

you know that that tends to get better

as well

got it is your spirit animal a bison

uh apparently um that that's what i

heard

um so i'll take it

excellent so uh one more time i want to

introduce

dr patterson's site uh i would keep

saying this so that there is no

confusion about this

i have no commercial financial

or any influence related interest

or engagement here

my interest with dr patterson and his

team's work

is to bring the long covered situation

the solution

to the masses and this is the site

the site is covered long haulers.com

there is another site and that is fsccc

and here there is a protocol as well i

would request that anybody who

is in a long-haul state please reach out

to dr patterson's group

try this protocol whichever way you want

to

but there is there is help out there

there is solution out there there is

research that

dr uh patterson just shared with us and

i hope that you all become better and

you recover very fast

and there is hope uh bruce any uh

comments before we

uh close well again it is about their

health but

um we're also pushing you know the

government to take care of these people

um you know the fact that they're just

recognizing that there's a thing called

you know long haulers or pask

um is mind-boggling

and um you know they need to step up the

plate

you know like the rest of us who are

working day and night like yourself

dr bean and dr corey and and

and the group over there at the flccc

and

uh doing great things over there and you

know we um

we're we're doing our part uh it's time

for

the government to step up the plate and

uh support these people and

provide the benefits that they need got

it

once again thank you very much for being

here thank you for sharing these

insights congratulations for this work

and congratulations to humanity

for your work which is going to give

benefit to people who are suffering

right now

thank you once again and hope to see you

again always a pleasure

look forward to it next time thanks

[EasySt]

“ Please keep us updated on Durham’s telegram posts… pretty please?“

~~~~~~

Michael Sussman will go down as a criminal in the history books.
Indictment is coming.

Join @John_Durham

https://t.me/John_Durham/14

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If a Clinton lawyer is indicted, who will protect the Clintons?

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BKMK

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Click to skip to the bottom of this post.

Number of adverse events published to VAERS which have the word 'leukemia' in the event description field. Includes those already taking medications for leukemia, and those for whom it was a new diagnosis.

The data was exported from VAERS 9/20/2021. 

Ymani, I made an export from VAERS in case you'd like to skim the adverse event description field for details that sound like a match (e.g., your friend).

The table below contains around 400 records sorted in order of manufactuerer (J&J, Moderna then Pfizer). I skimmed the 18 reports for J&J. Patients in row numbers 9, 11, 13,14,15 and 16 did not have a prior history of leukemia. I saw the following quote in row 13, which shows you how doctors have been taught to direct patients away from considering leukemia a possible result of Covid 'shots.'

" The patient was told if it gets better it would be vaccine-related and if it does not it could be leukemia"

There are row numbers on the far left of the table.

Moderna starts in row 19, and the patient has no prior history of leukemia. So, it takes looking  - I thought maybe you might like to read for clues about onset.

I believe Moderna has a disproportionate share of these events as Pfizer usually has far more doses administered.

Because this is VAERS, we can assume the count is incomplete in a number of different ways. If you're interested, I can try a better interface to the data. :) 

Grand Total 415

JANSSEN	18
MODERNA	187
PFIZER\BIONTECH	209
UNKNOWN VACCINES	1

 

Row	Vaccine Manufacturer	Adverse Event Description	Current Illness	VAERS ID	Age	Month Reported
1	JANSSEN	Started getting real bad body aches the night of the vaccine.  Aching, and Pain in lower back and sick feeling has lasted two weeks now? I dont know for sure if this is vaccine adverse conditon for sure, but all started after getting it? Could vaccine have affected my leukemia???	CLL Leukemia	1187744-1	65-79 years	2021/04
2	JANSSEN	TREMORS GOT BETTER; This spontaneous report received from a patient concerned a 79 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, chronic lymphocytic leukemia, essential tremors, asthma, and lung problem.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 24-MAR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ibrutinib for chronic lymphocytic leukemia.  On an unspecified date, the subject experienced tremors got better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tremors got better was not reported. This report was non-serious. This report was associated with product quality complaint.	Asthma; Chronic lymphocytic leukemia (Chemotherapy with Imbruvica (ibrutinib) for Chronic Lymphocytic Leukemia.); Diabetic; Essential tremor; Lung disorder	1189466-1	65-79 years	2021/04
3	JANSSEN	FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included leukemia, and bone marrow transplant, and concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fever. On 18-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.	Asthma	1253163-1	Unknown	2021/03
4	JANSSEN	DIARRHEA; SEVERE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included leukemia.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered in the left arm on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headache and diarrhea was not reported. This report was non-serious.	Leukemia	1253294-1	Unknown	2021/03
5	JANSSEN	NEUROENDOCRIME TUMOR; PAIN IN EXTREMITY; This spontaneous report received from a patient concerned a 64 years old male. The patient's weight, height, and medical history were not reported. The patient received Ibrutinib (tablet, oral, batch number: 1140389) 420 mg, every 1 day, from SEP-2020, for chronic lymphocytic leukemia.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported), start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced neuroendocrime tumor, and pain in extremity. Laboratory data (dates unspecified) included: PET scan (NR: not provided) which showed Neuro endocrine tumor. Treatment medications (dates unspecified) included: lanreotide to suppress the growth in every 28 days of tumor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ibrutinib was not changed. The patient was recovering from pain in extremity, and the outcome of neuroendocrime tumor was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-Covid-19 vaccine ad26.cov2.s-Neuroendocrine tumor. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.	No current illness for this event.	1261314-1	60-64 years	2021/04
6	JANSSEN	BURNING SENSATION ON LEG; SEVERE ABDOMINAL PAIN; HEADACHE; FATIGUE AND TIRED; This spontaneous report received from a parent concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included low platelet count, and concurrent conditions included leukemia, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On 01-JAN-2021, Laboratory data included: PCR (NR: not provided) NEGATIVE. On 20-APR-2021, the subject experienced burning sensation on leg. On 20-APR-2021, the subject experienced severe abdominal pain. On 20-APR-2021, the subject experienced headache. On 20-APR-2021, the subject experienced fatigue and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation on leg, severe abdominal pain, headache, and fatigue and tired. This report was non-serious.	Leukemia (History of leukemia with low platelet count .Has treatment for leukemia.)	1261342-1	50-59 years	2021/04
7	JANSSEN	TOE CRAMP; FINGER CIRCULATION ISSUE; DIZZINESS; TINNITUS; HEAD VIBRATING; TEETH VIBRATING/CHATTERING; LEG PAIN; FATIGUE; MUSCLE ACHE; SORENESS AT INJECTION SITE; FEVER, HOT FLUSHES THROUGHOUT CHEST; NAUSEA; CARDIAC FLUTTER; CHEST PAIN; MIGRAINE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included tonsillectomy, car accident, broken 2nd vertebrae, right femur-metal rod, smoker, radiculopathy 5/6, radiculopathy L5, bulging disc L4/L5, and mild degenerative disc disease L5/S1 and concurrent conditions included allergy to latanoprost eye drops, macrobid, bactrium, prednsisone, penicillin, elmiron, crestor, welchol, bentyl, librax, mercaptopur (6mp), lyrica, topimax, nuvigil, cymbalta, budesonide, humira, depakote IV, neurontin and mirena and very sensitive to medication, high blood pressure when in pain, migraines (neck pain, hormones, weather), fibromyalgia, interstitial cystitis, crohns- ileitis, gastritis, acid reflux, spinal stenosis, haemorrhoids, gastric polyp, high triglyceride's, low red blood cell count anemia (d and iron-sometimes), possible mild obstructive sleep apnea, restless leg, cats and dogs allergy, cockroach allergy and dust allergy, and the patient received vaccines: engerix-b, havrix, hep a & hep b. The patient was previously treated with botulinum toxin type for migraine, ethinylestradiol/norgestimate for birth control. The patients diet for IC included no maltodextrin, no sorbitol/sucralose/Splenda/equal, low sodium.  The patient's family history included sleep apnea in brother from 1982-2016, muscular dystrophy in maternal grandmother who was deceased at 70 and the mathernal grandmother also had cataracts, stroke, and diabetes and she took Diethylstilbestrol (DES), the patients mother had interstitial cystitis since 1955, hepatitis C, high cholesterol, sleep apnea, restless leg, died of lung cancer, the patients aunt had fibromyalgia, cataracts, and migraines, her cousin had severe Crohn's, patients paternal grandmother had leukemia and died at 45 years due to suicide, paternal grandfather had breast cancer and died at age of 50 years due to heart disease (heart attack), and her cousin mothers side had history of Crohn's and diverticulitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A) dose was not reported, administered on 03-APR-2021 at 01:15 in right arm for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride and guaifenesin for allergies; lisinopril for blood pressure due to back pain; hyoscyamine, infliximab, loperamide hydrochloride and ondansetron for crohns; oxybutynin, amitriptyline and milnacipran hydrochloride for interstitial cystitis and fibromyalgia; omeprazole and sucralfate for gastritis; butalbital/caffeine/paracetamol, curcuma longa rhizome, fish oil and riboflavin for migraine, ascorbic acid, calcium, folic acid, magnesium, and zinc for vitamins supplements.  On 03-APR-2021, within 10 mins of vaccination at 01:30 the patient experienced toe cramp. On an unspecified date in APR-2021, the patient experienced finger circulation issue, dizziness, tinnitus, head vibrating, teeth vibrating/chattering, fatigue, muscle ache, soreness at injection site, fever, hot flushes throughout chest, nausea, cardiac flutter, chest pain, migraine, and leg pain and visited emergency room on 10-ARP-2021.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 F, Chest X-ray (NR: not provided) unknown, and Troponin (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the toe cramp, fatigue, finger circulation issue, fever, hot flushes throughout chest, soreness at injection site, muscle ache, tinnitus, teeth vibrating/chattering, migraine, cardiac flutter, leg pain, chest pain, head vibrating, nausea and dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Cardiac flutter. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.	Allergy to animal; Anemia, unspecified; Blood pressure high; Cockroach allergy; Crohn's ileitis; Cystitis interstitial; Drug allergy (The patient has allergy to Latanoprost eye drops-it feels like alcohol poisoning, Macrobid & Bactrium-Rash, prednsisone at high levels, long term √ steroid myopathy cats, dogs, dust, roaches. Adverse: Penicillin & Elmiron-stomach issues, Statins, Crestor, welchol, Bentyl & Librax-dizziness & fatigue, Mercaptopur (6MP)- nausea, kidney/liver issues, Lyrica- tremors/twitching (stop 11/29/2012) Topimax - numb face and tongue & shock sensations throughout nervous system, Nuvigil √ loose stools, tiredness, nausea, rash. Cymbalta: brain shocks when lowered dose. Budesonide (some steroid myopathy issues after a month	1262094-1	Unknown	2021/04
8	JANSSEN	NEGATIVE ANTIBODY TEST; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight was 125 pounds, and height was 170 centimeters. The patient's past medical history included chronic lymphatic leukemia, frequent urination, and drug abuse, and other pre-existing medical conditions included the patient had no known drug allergies, non-smoker and non-alcoholic. the patient used marijuana for drug abuse. The patient was previously treated with lithium, and cannabis sativa for drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced negative antibody test. Laboratory data included: Antibody test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from negative antibody test. This report was non-serious.	No current illness for this event.	1269174-1	Unknown	2021/04
9	JANSSEN	Patient received J&J vaccine dose #1. Over the next two weeks, developed fatigue, anorexia, and malaise (had been fatigued prior to dose). Presented to local hospital and ultimately was diagnosed with acute megakaryocytic leukemia. Now in hospital for initial treatment of leukemia. Unlikely to be related to vaccine, reporting due to hospitalization and severity of illness.	None diagnosed (see report)	1274327-1	50-59 years	2021/04
10	JANSSEN	DULL ACHE TO RIGHT ARM/ PAINFUL TO SLEEP ON THAT SIDE; INJECTION SITE PAIN- RIGHT ARM; This spontaneous report received from a consumer concerned an 81 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic lymphocytic leukemia, and sulfa allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAY-2021, the subject experienced injection site pain- right arm. On 17-MAY-2021, the subject experienced dull ache to right arm/ painful to sleep on that side. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site pain- right arm on 04-MAY-2021, and had not recovered from dull ache to right arm/ painful to sleep on that side. This report was non-serious.	Chronic lymphocytic leukemia; Sulfonamide allergy	1366821-1	80+ years	2021/06
11	JANSSEN	CHRONIC LYMPHOCYTIC LEUKEMIA; This spontaneous report received from a patient via a company representative concerned a 62 year old white and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 and patient was in bed for 18 days and concurrent conditions included fatigue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 15-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in MAR-2021, The patient developed pain in joints or bones. On 17-MAR-2021, two days later, the patient felt very tired and extreme fatigue. On 24-MAY-2021, the patient had additional bloodwork and CT Scan and has been diagnosed with Chronic Lymphocytic Leukemia (CLL) On 24-MAY-2021, laboratory data included: Blood neutrophils (NR: 42.2 - 75.2) 25.3 %, Blood neutrophils (NR: 1.4 - 6.5) 3.5 10*3/uL, Blood test (NR: not provided) Elevated WBC, CT scan (NR: not provided) Enlarged lymph nodes., Haemoglobin (NR: 11.0 - 18.0) 12.5 g/dL, Hematocrit (NR: 35.0 - 60.0) 40.3 %, Lymphocytes (NR: 20.5 - 51.1) 70.7 %, Lymphocytes (NR: 1.2 - 3.4) 9.7 10*3/uL, MCH (NR: 37.0 - 31.0) 28.0 pg, MCHC (NR: 33.0 - 37.0) 30.9 g/dL, MCV (NR: 80.0 - 99.9) 90.4 fL, Mean platelet volume (NR: 708 - 11.0) 7.0 fL, Monocytes (NR: 1.7 - 9.3) 4.0 %, Monocytes (NR: 0.1 - 0.6) 0.5 10*3/uL, Plasminogen activator inhibitor (NR: 150.0 - 450.) 261 10*3/uL, Prophylaxis (NR: 4.00 - 6.00) 4.46 10*6/uL, Red cell distribution width (NR: 16.6 - 13.7) 13.8 %, and WBC (NR: 4.5 - 10.5) 13.7 10*3/uL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme fatigue/ very tired, and the outcome of joint pain, chronic lymphocytic leukemia and bone pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210614079-covid-19 vaccine ad26.cov2.s-Chronic Lymphocytic Leukemia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).	Fatigue	1390698-1	60-64 years	2021/06
12	JANSSEN	ACHY JOINTS; This spontaneous report received from a patient via a company representative concerned a 74 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic leukemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced achy joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy joints on APR-2021. This report was non-serious.	Chronic leukemia	1463885-1	Unknown	2021/07
13	JANSSEN	ABNORMAL LABWORK; LOW LYMPHOCYTES; HIGH NEUROCYTES; LOSS OF CONSCIOUSNESS; VASOVAGAL EVENT; ALMOST CONVULSIVE; PROFUSE VOMITING; DISORIENTED; FELT VERY STRANGE; CHILLS; EXTREME FATIGUE; STRANGE HEADACHE ON RIGHT SIDE OF HEAD; This spontaneous report was received from a 54-year-old female patient. The patient's weight was 140 pounds, and height was 62 inches. The patient's concurrent conditions included type 2 diabetes mellitus, fibromyalgia, social alcohol drinker, seasonal allergy, and coronavirus disease (covid-19). The patient had covid in NOV-2020, from which she got severe neurologic effects, and was still not fully recovered from covid and continued to experience severe vertigo, ringing in ears, and taste and smell have still not fully returned at the time of reporting. The patient does not smoke, had no drug abuse/illicit drug use and no drug allergies. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, 1 total, administered on left arm on 08-MAY-2021 for prophylactic vaccination. It was unknown if the product was stored in appropriate temperature conditions and if it was properly stored from receipt to administration. No concomitant medications were reported.  On 08-MAY-2021, following vaccination, the patient at first felt totally fine, however, after 4 to 4.5 hours, the patient felt everything was going black and she passed out (loss of consciousness) and vomited profusely. She was out cold for about five minutes and woke up shaking with extreme chills and was almost convulsive following which an ambulance was called. The patient woke up in the back of the ambulance and told the emergency medical technicians (EMTs) that she was vaccinated and the EMTs said it was just a vasovagal event. The patient was taken to the emergency room (ER) and the ER doctor told the same thing. The patient's blood was taken and she was given intravenous (IV) fluids. The patient felt very strange, similar to what she felt at the time she got covid but it was milder. The patient felt disoriented, extreme fatigue, and a strange headache on the right side of head. At the hospital that day, a computed tomogram (CAT) scan was done but, it was clear. The patient was then released on the same day. On 09-MAY-2021, the bloodwork results came and was very alarming (abnormal lab work; detailed results not provided). The patient then reached out to her healthcare professional (HCP) for lab review and they were very concerned about the results. Her lymphocytes were low and 'neurocytes' were high (as reported), 'everything was off'. The patient was asked to wait for few days for more lab tests be taken during that time. The patient was told if it gets better it would be vaccine-related and if it does not it could be leukemia. Her disorientation, fatigue, and headache lasted for about 5 days until around 13-MAY-2021. The blood work started to return to normal after a few more days, and the HCP confirmed it was vaccine-related. The patient stated that her research showed that the adverse events could be a result of her covid, and not vaccine-related. All of her adverse events went on within the first week following the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, vasovagal event, almost convulsive, profuse vomiting, and chills on 08-MAY-2021, and disoriented, felt very strange, extreme fatigue, strange headache on right side of head, abnormal labwork, low lymphocytes, and high neurocytes on 13-MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210730727-Covid-19 vaccine ad26.cov2.s-Loss of consciousness, Vasovagal event, Almost convulsive, Profuse vomiting, Disoriented, Felt very strange. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210730727-Covid-19 vaccine ad26.cov2.s-Chills ,Extreme fatigue, Strange headache on right side of head. This event(s) is labeled per RSI and is therefore considered potentially related.	COVID-19 (Patient had Covid in NOV-2020, from which she got neurologic affects severely, and still not fully recovered from Covid and continues to experience severe vertigo, ringing in ears, and taste and smell have still not fully returned.); Fibromyalgia; Non-smoker; Seasonal allergy; Social alcohol drinker (socially); Type II diabetes mellitus	1485946-1	50-59 years	2021/07
14	JANSSEN	approximately one week of receiving the J & J vaccine, I developed symptoms which when diagnosed a couple of weeks later turned out to be acute Myleoid leukemia	none	1523657-1	60-64 years	2021/08
15	JANSSEN	Fatigue and trouble breathing.  Blood tests led to diagnosis of Acute B Lymphoblastic leukemia. Current treatment is aggressive chemotherapy. Blood transfusions	No current illness for this event.	1558249-1	30-39 years	2021/08
16	JANSSEN	ACUTE LEUKEMIA; This spontaneous report received from a patient via a media article concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was diagnosed with acute leukemia after vaccination. Laboratory data included: Diagnostic procedure (NR: not provided) acute leukemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of acute leukemia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210908666-Covid-19 vaccine ad26.cov2.s-Acute leukemia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).	No current illness for this event.	1677101-1	Unknown	2021/09
17	JANSSEN	Hospitalized;  COVID-19 positive (8.29.21);  fully vaccinated. DATE OF ADMISSION:  08/30/2021 DATE OF DISCHARGE:  09/01/2021     PROVISIONAL DIAGNOSES 1. COVID-19 infection. 2. Coagulase-negative staphylococci positive blood culture. 3. Recent status epilepticus with history of childhood epilepsy. 4. Chronic myeloid leukemia, status post allo-HSCT, 10/08/2019. 5. Chronic graft-versus-host disease of skin and eyes. 6. History of lower extremity deep vein thrombosis. 7. Chronic pain. 8. History of pancytopenia. 9. History of attention deficit hyperactivity disorder. 10. History of asthma. DISCHARGE DIAGNOSES 1. COVID-19 infection. 2. Coagulase-negative staphylococci positive blood culture, suspected contaminant. 3. Recent status epilepticus with history of childhood epilepsy. 4. Chronic myeloid leukemia, status post allotransplant in October 2019. 5. Chronic graft-versus-host disease of the skin and eyes. 6. History of left lower extremity deep vein thrombosis. 7. Chronic pain. 8. History of pancytopenia with normocytic anemia. 9. History of attention deficit hyperactivity disorder. 10. History of asthma. CONDITION ON DISCHARGE Stable. PROCEDURES PERFORMED None. CONSULTATIONS 1. Bone Marrow Transplant team. 2. Infectious Disease   HOSPITAL COURSE The patient is a very pleasant 28-year-old male with past medical history as listed above including history of CML, status post allo stem cell transplant in October 2019; graft-versus-host disease; recent status epilepticus requiring ventilator for airway protection; and now newly diagnosed COVID-19, who presents to Emergency Department secondary to worsening symptoms.  The patient was seen in the Emergency Department on August 29 with symptoms of fatigue, nausea, vomiting, and cough.  COVID-19 was positive at that time.  Blood cultures were obtained.  The patient was discharged home.  He returned the following day with worsening symptoms.  It was also noted that a single blood culture was positive for coag-negative staph.  With the COVID positivity, the patient did receive Regeneron antibodies on August 29.  Dex was not started as the patient was not hypoxic.  He was medically stable with stable vital signs and was admitted and started on IV fluid hydration.  Blood cultures were redrawn and he was started on empiric vancomycin.  The coagulase-negative staph positive blood culture was felt likely to represent contamination, but in the setting of immunocompromised state and COVID infection, Infectious Disease was consulted.  They agreed this was likely contaminant.  Oral vancomycin was discontinued.  Repeat blood cultures remained negative at 48 hours.  ID recommended starting remdesivir on 08/31 given he was less than 7 days into symptoms and his cycle threshold is on the lower side.  Chest x-ray was obtained and was negative for acute process.  The patient remained very stable and had clinical improvement and was felt medically stable for discharge on 09/01/2021.  He will receive a second dose of remdesivir prior to discharge.  Given immunocompromised state, the patient may discontinue quarantine respiratory isolation on September 15.  The Bone Marrow Transplant team was consulted and will arrange outpatient followup.	Hospitalized for COVID-19 / fatigue.  (patient is s/p allogeneic bone marrow transplant in 2019)	1678858-1	18-29 years	2021/09
18	Janssen	NEUROENDOCRIME TUMOR; PAIN IN EXTREMITY; This spontaneous report received from a patient concerned a 64 years old male. The patient's weight, height, and medical history were not reported. The patient received Ibrutinib (tablet, oral, batch number: 1140389) 420 mg, every 1 day, from SEP-2020, for chronic lymphocytic leukemia.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported), start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced neuroendocrime tumor, and pain in extremity. Laboratory data (dates unspecified) included: PET scan (NR: not provided) which showed Neuro endocrine tumor. Treatment medications (dates unspecified) included: lanreotide to suppress the growth in every 28 days of tumor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ibrutinib was not changed. The patient was recovering from pain in extremity, and the outcome of neuroendocrime tumor was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-Covid-19 vaccine ad26.cov2.s-Neuroendocrine tumor. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.	No current illness for this event.	1261314-1	60-64 years	2021/04
19	MODERNA	Patient began experiencing fevers, body aches, back pain, fatigue, chills the night she received the vaccine. Symptoms progressed for the following four days when she was ultimately seen in PCP office. Laboratory evaluation demonstrated atypical pneumonia and elevated WBC count. Patient was diagnosed with Acute Myeloid Leukemia via bone marrow biopsy and is receiving treatment at the hospital.	Strep	0936993-1	40-49 years	2021/01
20	MODERNA	Acute pancreatitis; Acute renal failure; Low blood pressure; Weakness; Decreased appetite; Fatigue; Alanine aminotransferase increased; Aspartate aminotransferase increased; Troponin increased; Lipase increased; Blood bilirubin increased; A spontaneous report was received from a physician concerning an 81-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an odd presentation of acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue.  The patient's medical history included advanced dementia, heart disease, pulmonary embolism and possible leukemia. Concomitant product use was not provided by the reporter.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 08 Jan 2021, three days after vaccination, the patient developed symptoms of weakness, decreased appetite, and fatigue.   On 11 Jan 2021, the patient was admitted into the hospital with a diagnosis of low blood pressure,acute renal failure,acute pancreatitis,alanine aminotransferase increased,aspartate aminotransferase increased, troponin increased,lipase increased and blood bilirubin increased. Abnormal lab results included ""significantly elevated"" aspartate transaminase, alanine transaminase, bilirubin, lipase up to 1900, and ""slightly elevated"" troponin of 0.079.  On 13 Jan 2021, the patient's symptoms had improved, and he was discharged. Treatment for the event included two liters of intravenous fluid and supportive care.   Action taken with the second dose of mRNA-1273 in response to the event was not provided.    The events, acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue, were considered resolved on 13 Jan 2021.   The physician assessed the events, acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue, as not related to mRNA-1273. The physician's rationale was that the patient may have had a gallstone obstructing the pancreatic duct and once the stone passed, the patient got better with supportive care and slow administration of fluids.; Reporter's Comments: This case concerns a 81-year-old male patient with medical history of dementia, heart disease, pulmonary embolism, and possible leukemia, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of acute pancreatitis, acute renal failure, low blood pressure, the non-serious listed event of fatigue, and the non-serious unlisted events of weakness, decreased appetite, elevated aspartate transaminase, elevated alanine transaminase, elevated bilirubin, elevated lipase, and elevated troponin.  Very limited information regarding these events has been provided at this time.  Based on the current available information and in agreement with the physician reporter's assessment, the events are assessed as unlikely related to mRNA-1273, noting the rapid improvement after administration of IV fluids.""	Dementia (Advanced); Heart disease, unspecified; Living in nursing home	0980352-1	80+ years	2021/01
21	MODERNA	I work at  medical center where patient is being treated for a new diagnosis of Acute monocytic leukemia.  I was able to that the patient was vaccinated with Moderna vaccine on 1/16/2021, patient does not have the vaccination card with the Lot number so this is unknown at this time.  Here are the details I see in the chart. Patient arrived on   1/30/2021 at 2100, per History and physican patient has not been feeling well for about a week and a half, and had received the moderna vaccine approximately 2 weeks prior to this time.  Doctors note states about a week after first COVID vaccine she noted chest and back pain, dyspnea, high grade fevers and for this went to the ER on 1/28/21 and found to have anemia Hemoglobin 10 with normal LFTs.  She was thought to have a reaction to vaccination and sent home.  When her symptoms did not get better she went to ER again on 1/30 and found to have Hemoglobin down to 8 and marked LFTs elevation.  Pathology evaluated elevated WBC and showed monocytosis and possible blast cells and patient transferred for further workup.      per oncologist patient went to primary care about 6 months ago and had a normal CBC.   Patient was started on chemotherapy for diagnosis of  AML during this admission, as of 2/9/2021 patient remains inpatient, is intubated in ICU with prognosis unknown at this time.	felt healthy and hiking 3-4  miles per day previous to vaccination	1017765-1	65-79 years	2021/02
22	MODERNA	Pt is a 76-year old with SIDEROBLASTIC ANEMIA that had been mild and  without need for treatment, and IgM MGUS. Presented to ED with newly diagnosed AML, in MDS with WBC counts ~250, 000.    He had a normal (EX ANEMIA) CBC on Jan-21. He had COVID vaccine #1 on Jan-25.  About 4-days later he developed diffuse dermititis and severe fatigue. He had an  ED visit on Feb-8 for these issues and was prescribed Prednisone and Cefalexin  (completed Feb-15).  CBC was NOT done at that ED visit. He called HEME clininc  on Feb-16 (see also the Hematology Note) stating that he was just NOT feeling  well in general with increased fatigue and DOE. He noted that the dermatitis was  mostly resolved. We rechecked CBC on Feb-17 (results available about 4-PM) that  indicated ACUTE LEUKEMIA.  Presents to the MC with MDS on FEB18.	sideroblastic anemia, BCC. Hypothyrodism, and prostatecancer, SCC	1039221-1	65-79 years	2021/02
23	MODERNA	Developed pruritic rash that began approximately 48 hrs after vaccination and lasted 1 week then resolved. He had bloodwork done 48 hrs after vaccination prior to giving blood. He was told that he was ""positive for HIV and leukemia"" based on that bloodwork. He was then seen by PCP and had repeat labs which were normal. He denies any further symptoms. The PCP attributed the false positive lab results to having the COVID vaccine 48 hrs prior to initial labwork.""	No current illness for this event.	1048914-1	60-64 years	2021/02
24	MODERNA	Patient was diagnosed with acute leukemia within 6  weeks of receiving first and 2 week of receiving second Covid Vaccine.  I do NOT think vaccine caused the leukemia, but am reporting it in view of timing of her having received the vaccine and being diagnosed.	No current illness for this event.	1064080-1	65-79 years	2021/03
25	MODERNA	2/28/21 Patient presented and was admitted through the emergency department for confusion, weakness, and low grade temperature (100.1 F). On admission, pertinent labs were Hgb of 5.1, WBC 60k which was consistent with autoimmune hemolytic anemia (AIHA).. Patient was diagnosed with chronic lymphocytic leukemia in 2016. The patient has had a prior history of AIHA in 2017.  Per the Agency, hospitalizations are to be reported irrespective of attribution to vaccine.	No current illness for this event.	1065546-1	80+ years	2021/03
26	MODERNA	I have been taking Sprycel for a month without any problems for my leukemia ,  I had my vaccine at 12:30 PM, after my dinner I took the medication which was around 6:30 PM. At around 2:30, 3:00 AM I woke up with running diarrhea which lasted until around 4:00 AM. I had a suppository and used that to stop the diarrhea but the diarrhea kept coming, I finally drank Pedialyte  which I keep because I have had issues in the past . Just a side note my right arm was really hurting and I could not lift it for one day	No current illness for this event.	1098845-1	65-79 years	2021/03
27	MODERNA	Her doctor said she may have possible leukemia; Soreness; Redness the size of a quarter, Redness was 2 inches round, Redness is 4.5 inches in length and 3.5 inches in width; Pain at the injection site, couldn't sleep, every time I turned, it was painful; Rash; Pain at the injection site, couldn't sleep, every time I turned, it was painful; Terrible pain on her arm; A spontaneous report was received from a consumer who was also a 81-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced soreness, pain at the injection site, couldn't sleep, vaccination site pain,  redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width. Patient's doctor suspecting leukemia.    The patient's medical history included COVID 19 infection on 13 Oct 2020. Products known to have been used by the patient, within two weeks prior to the event, included hydroxyurea nonspecific.  On 13 Feb 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031M20A) intramuscularly in the Left Deltoid for prophylaxis of COVID-19 infection.  On 13 Feb 2021 at night 11pm, patient began to feel pain at the injection site. Patient reported that patient couldn't sleep all of Saturday night, every time patient turned, it was painful. By Monday, the pain turned into just soreness, however, patient developed redness the size of a quarter at the injection site. Two days before reporting, the redness was 2 inches round and currently the redness is 4.5 inches in length and 3.5 inches in width, which indicates that it was spreading. Patient reached out to patient's doctor. Patient also reported some itching at the injection site last night. The patient also reported Rash, terrible pain on arm, and COVID-arm reaction. Patient's also reported that her doctor is suspecting a leukemia.  Treatment for the event included ice on the area 3 times a day, 15 minutes at a time.  Action taken with mRNA-1273 in response to the events was not provided.  The events,  soreness, pain at the injection site, couldn't sleep, every time turned, it was painful, COVID arm reaction, terrible pain on her arm, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width, rash, were considered recovered on an unspecified date and The outcome of  the event leukemia is unknown.  Addition information Additional information received on 01 Mar 2021 included outcome of the events , pain at the injection site, couldn't sleep, every time turned, it was painful, COVID arm reaction, terrible pain on her arm, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width, rash and reported patient was suspecting leukemia.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.	No current illness for this event.	1107179-1	80+ years	2021/03
28	MODERNA	Tired; Passed out, was semi-unresponsive; Vein was hit on vaccination; Arm blew up after the shot (swelled); Arm was still back and blue; Extreme weakness; Wanted to sleep/slept for 24 hours/slept the rest of the day; A spontaneous report was received from a consumer, concerning herself, a 71-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and was passed out, was semi-unresponsive; vein was hit on vaccination; arm blew up after the shot (swelled); arm was still back and blue; extreme weakness; wanted to sleep/slept for 24 hours/slept the rest of the day and tired.~  The patient's medical history includes leukemia ongoing since on an unspecified date and was not being treated. Concomitant medications were not reported.  On 23-Feb-2021, prior to onset of events, the patient received their second of two planned doses of mRNA-1273 injection, (Lot/Batch number: 001A21A) intramuscularly in their left arm for prophylaxis of COVID-19 infection.   On 23-Feb-2021, after the second dose of vaccine, the patient's arm blew up (swelled) and passed out, duration unknown, followed by less responsive with extreme weakness and sleepiness. Patient was sent to the ER (Emergency Room) where she was administered with fluids and anti-nausea medication and was released. Patient also informed that her vein was hit during the vaccination. Patient slept for 24 hours. On 24-Feb-2021, she was only awake for five hours. She again slept the rest of the day. At the time of this report, patient's arm was still back and blue, and was still tired but she was also much improved and is staying hydrated.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome for the event, arm was still back, and blue was considered not resolved at the time of this report. The outcome for event tired was resolving at the time of this report. The outcome for events, passed out, was semi-unresponsive; vein was hit on vaccination; arm blew up after the shot (swelled); extreme weakness; wanted to sleep/slept for 24 hours/slept the rest of the day were resolved on 23-Feb-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.	Leukemia (Is not being treated)	1107189-1	Unknown	2021/03
29	MODERNA	Developed leukemia and kidney failure. Died in 6 days.	No current illness for this event.	1107648-1	80+ years	2021/03
30	MODERNA	had a blood test that showed he had pancytopenia and ""his hcp gave him a preliminary diagnosis of Pre-Leukemia; preleukemia; Fatigue; A spontaneous report was received from a consumer concerning a 74 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Fatigue and the patient also reported that he had a blood test that showed he had pancytopenia and ""his HCP gave him a preliminary diagnosis of Pre-Leukemia"". The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030l20a) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032h20a) in the left arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, one day after the 2nd vaccine, patient experienced fatigue. On 04 Mar 2021, the patient had a blood test that showed he had pancytopenia and ""his HCP  gave him a preliminary diagnosis of Pre-Leukemia"".  Patient stated that last year he had normal results and he was going to see a doctor in two weeks.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event Fatigue was reported as resolved on 23 Feb 2021.  The outcome of the events, pancytopenia and preliminary diagnosis of Pre-Leukemia, was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.""	No current illness for this event.	1129674-1	65-79 years	2021/03
31	MODERNA	plates went from normal to 3000; A spontaneous report was received from a consumer concerning a 76-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced having platelets went from normal to 3000 (Thrombocytopenia-unspecified).    The patient's medical history, as provided by the reporter, included leukemia. No relevant concomitant medications were reported.   On 27 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030O20A) intramuscularly for prophylaxis of COVID-19 infection.    On 07 Feb 2021, the patient had an infusion of obinutuzumab for leukemia because her platelets went from normal to 3000. She was at the hospital for three days.  Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, platelets went from normal to 3000 was unknown.; Reporter's Comments: This case concerns a 76-year-old female who was hospitalized for infusion of obinutuzumab for leukemia because of a medically significant and serious unexpected event of thrombocytopenia.  Event onset occurred 22 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.	Leukemia	1129726-1	65-79 years	2021/03
32	MODERNA	Patient received 1st dose Moderna on 2-17-2021 and 10 days later patient relapsed on ALL (type of Leukemia). Per caregiver, patient has been in the hospital for 26 days. May or may not be related to vaccine. Patient will not be getting the 2nd dose.	Cancer survivor	1134379-1	18-29 years	2021/03
33	MODERNA	Patient went to have labs done for her leukemia checkup 3/24. Patient has had leukemia for many years and has had many blood draws. Patient had blood taken at her appointment and was waiting when the nurse came back out and said her blood had clotted so they needed to redraw her blood. She states this has never happened before and wondered if her blood clotting would have been due to her covid vaccine the week prior. She states the first girl who drew her blood was slower than the second time around when a different nurse drew her blood.	Leukemia since 1989  Had dental work done 3/15 (had four fillings) & 3/16 (Had tooth extraction)	1134671-1	80+ years	2021/03
34	MODERNA	Diagnosis of ITP (immune thrombocytopenic purpura); Spontaneous rectal bleeding; Little bit of soreness; A spontaneous report was received from a consumer concerning reporter's mother a 90-year-old, female patient, who was diagnosed ITP (immune thrombocytopenic purpura)/immune thrombocytopenia, body's immune system attacking its own immune system/autoimmune disorder, spontaneous rectal bleeding/rectal haemorrhage, platelets abnormal/platelet disorder and little bit of soreness/pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 05 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route in the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, patient's blood platelets were zero which was considered as life threatening event. On 13 Feb 2021 Saturday, patient had spontaneous rectal bleeding for which patient was taken to emergency room and admitted to ICU. Then patient was transferred to another hospital where patient was diagnosis of ITP (immune thrombocytopenic purpura) where body's immune system attacking its own immune system. The patient was seen by hematologist for 8 days. After vaccination the patient felt little bit of soreness, but patient was completely fine.   The patient had three platelet counts one on 13 Feb 2021, in which showed a result of zero platelet, on 22FEB2021 platelet count increased to 57 and unknown date patient platelet count was 357. The patient also had tested for leukemia, blood cancers, and other blood work came normal.  Treatment for the event included two Blood transfusions, IV steroids, Oral steroids maximum dose, Rituxan, N-platelet injections nonspecific.  Action taken with mRNA-1273 in response to the events was not provided.  The events, ITP (immune thrombocytopenic purpura), body's immune system attacking its own immune system, spontaneous rectal bleeding, platelets abnormal and little bit of soreness, were considered recovering on the time of reporting.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments:  MOD-2021-047223:Crosslinked case	No current illness for this event.	1135307-1	80+ years	2021/03
35	MODERNA	Abnormal CT of the abdomen Anemia due to GI blood loss CLL (chronic lymphocytic leukemia) (CMS/HCC) Abnormal EKG  Macrocytosis Anemia requiring transfusions Symptomatic anemia	No current illness for this event.	1145392-1	80+ years	2021/03
36	MODERNA	mild case of pneumonia; no appetite; body temperature was 4-5F above baseline; lost 10 pounds in 10 days; xray were similar to someone to had covid; Vomiting; Forgetfulness; uncoherent and unresponsive episode; body tremors; weakness; A spontaneous report  was received from a consumer concerning a 71-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced memory impairment, pneumonia, asthenia, decreased appetite, body temperature increased, incoherent, vomiting tremors and weight decreased.   The patient's medical history included leukemia/AML since an unknown date in SEP-2017 and Stem cell transplant since an unknown date in JAN-2018.  No relevant concomitant medications were reported.   On 18-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.   On the same day, the patient experienced the events weakness, no energy, no appetite, body temperature were 4-5F above baseline. On 21-JAN-2021, the patient started experiencing body tremors and incontrollable shaking, both are worse at night. On 24-JAN-2021, he had an episode being uncoherent and unresponsive. On 25-JAN-2021, his resting heart rate was increased at 93BPM and his respiratory rate was also increased at 21 RPM. On 26-JAN-2021, he started vomiting and was forgetful. On an unknown date during a follow-up visit with PCP he was prescribed with antibiotics due to a mild case of pneumonia and suspected COVID-19.   Laboratory details included a negative COVID test performed on 22JAN2021 and some blood tests showing elevated WBC on 26JAN2021. He also had done a neuroscan and chest X-rays with unknown results.    Treatment information included antibiotics for the indication pneumonia.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events , memory impairment, pneumonia, asthenia, decreased appetite, body temperature increased, incoherent, vomiting tremors and weight decreased was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Patient's advanced age along with underlying conditions may have been contributory for the occurrence of the events. Further information has been requested.	Leukemia	1149901-1	65-79 years	2021/03
37	MODERNA	Patient fully recovered from natural SARS-COV-2 infection in early December 2020.  Patient was doing quite well between mid December and mid January.  Patient was hospitalized with congestive heart failure in late January 2021.  Received first dose of Moderna COVID19 vaccine shortly before being discharged around February 1 (not sure of exact date).  Patient was feeling well at that time.    Patient became quite ill within 24 hours of Moderna COVID19 vaccine. Patient steadily worsened during February 2021.  Was hospitalized in mid February (unsure of date) and diagnosed with kidney failure and liver disease.  Congestive heart failure rapidly worsened and previously stable leukemia flared up.  Patient was discharged from hospital February 19 and was placed in quarantine at Care Center.  Patient was considered terminal and was to go into hospice care.  Patient was administered second COVID19 vaccine on February 25, rapidly deteriorated, and died on March 1.	Leukemia, congestive heart failure	1170447-1	80+ years	2021/04
38	MODERNA	Tired; Aches all over the body; Neutropenia; A spontaneous report was received from a consumer (patient) concerning a 70-year-old, female patient was who received Moderna's COVID-19 Vaccine (mRNA-1273) and had neutropenia (neutropenia), tired (fatigue), aches all over the body (myalgia).  The patient's medical history included leukemia. No concomitant medications were reported.   On 01 Feb 2021, five days before the onset of events, the patient received their second of the two planned doses of mRNA-1273 (Batch number: 012M20A), intramuscularly for the prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient had a low count white cells (neutropenia). On 12 Feb 2021, she repeated the blood test and the white cells were perfect. On 02 Mar 2021, the patient was tired and had aches all over the body.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The event, neutropenia was considered recovered/resolved on 12 Mar 2021.  The outcome of the events, tired (fatigue) and aches all over the body (myalgia), was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.	Leukemia	1173592-1	Unknown	2021/04
39	MODERNA	stroke; light headed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included CML (CML Leukemia though she's in remission now) in 1999 and Surgery (Open eye surgery (2 & half year ago)). Concurrent medical conditions included Prediabetes, Blood pressure (Taking medication for blood pressure) and Renal disorder NOS (Taking medication for her kidneys). Concomitant products included METOPROLOL for BP, ATORVASTATIN for Cholesterol, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and life threatening). On 05-Apr-2021, the patient experienced DIZZINESS (light headed). The patient was hospitalized from 20-Mar-2021 to 23-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) had resolved and DIZZINESS (light headed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However,  patient's past medical history of CML, hypertension, Hyperlipidemia may contribute to this event. Further information is requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However,  patient's past medical history of CML, hypertension, Hyperlipidemia may contribute to this event. Further information is requested.	Blood pressure (Taking medication for blood pressure); Prediabetes; Renal disorder NOS (Taking medication for her kidneys)	1188859-1	65-79 years	2021/04
40	MODERNA	Deep vein thrombosis; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for CLL.    The patient's past medical history included Blood immunoglobulin G (low levels from past 20 years). Concurrent medical conditions included Chronic lymphocytic leukemia, Depression, Drug allergy (allergic reaction to Rituxan.) and Glaucoma. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   In February 2020, the patient started IBRUTINIB (IMBRUVICA) (unknown route) 420 milligram once a day. On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 antibody test (610-1600): 347 (Negative) 347.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other history included:no alcohol use, no drug abuse, non smoker Treatment information were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's past medical history of CLL and drug IBRUTINIB can contribute to this event. further information has been requested   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's past medical history of CLL and drug IBRUTINIB can contribute to this event. further information has been requested	Chronic lymphocytic leukemia; Depression; Drug allergy (allergic reaction to Rituxan.); Glaucoma	1189625-1	65-79 years	2021/04
41	MODERNA	Covid Pneumonia; High fevers; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (Covid Pneumonia) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Leukemia.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced COVID-19 PNEUMONIA (Covid Pneumonia) (seriousness criteria hospitalization and medically significant) and PYREXIA (High fevers). At the time of the report, COVID-19 PNEUMONIA (Covid Pneumonia) and PYREXIA (High fevers) outcome was unknown.            Hospitalization- treatment with remdesivir x 2 courses and other unknown monoclonal antibodies. Is on oxygen.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.	No current illness for this event.	1206921-1	65-79 years	2021/04
42	MODERNA	Pt developed fevers > 103F, severe headache, transaminitis, hypoxia (ultimately requiring 7L/min O2 via nasal cannula), and severe pancytopenia resulting in hospitalization and a bone marrow biopsy w/ flow cytometry (ultimately negative for leukemia/lymphoma). Her symptoms improved with IV decadron> oral prednisone, though cytopenias are now recurring 4/14/21. Pt had a positive ANA to 2.72 (but was taking doxycycline for anaplasmosis- now PCR and AB titers are negative for Anaplasma) and a positive ENA AB, Anti-Ro is high at 8.0. She has no family hx of autoimmune disease. Her infectious work-up for HIV, EBV, CMV, Blastomycosis, Histoplasmosis, Coccidioides, tickborne pathogens, & ricketsial disease is negative.	No current illness for this event.	1209570-1	18-29 years	2021/04
43	MODERNA	Death Narrative: Patient received his first COVID-19 vaccination 2/27/2021 and received his second COVID-19 vaccination 03/27/2021. Patient had not been tested for COVID per chart review and had no contraindications to receiving the vaccine. Patient did not experience any adverse events to the COVID-19 vaccine between time of vaccination and the time of death 12 days later. Of note, patient was receiving home hospice at the time of his death (04/08/2021) for his advanced acute myeloid leukemia.	No current illness for this event.	1213285-1	80+ years	2021/04
44	MODERNA	Patient admitted 3/28/2021 with severe COVID 19 pneumonia.  She progressed to acute respiratory failure and was intubated.  During her hospitalization she was diagnosed with acute myeloblastic leukemia.  Her family withdrew care and she died on 4/7/2021	depression, hyperlipidemia	1216264-1	80+ years	2021/04
45	MODERNA	elevated BCR-ABL after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PHILADELPHIA CHROMOSOME POSITIVE (elevated BCR-ABL after vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history was not provided.  Concurrent history include leukemia (CML)  On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 09-Mar-2021, the patient experienced PHILADELPHIA CHROMOSOME POSITIVE (elevated BCR-ABL after vaccine) (seriousness criterion medically significant). The patient gets routine blood drawn and it was elevated .   At the time of the report, PHILADELPHIA CHROMOSOME POSITIVE (elevated BCR-ABL after vaccine) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.      No treatment details were provided.; Sender's Comments: Based on the information provided, a causal association between the event of elevated BCR-ABL  and the administration of the vaccine is assessed as not related.  Event is inherent to the nature of the underlying malignancy.  Patient has a history of leukemia.	No current illness for this event.	1220867-1	60-64 years	2021/04
46	MODERNA	Pneumonia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia (No special treatment for leukemia received.) and White blood cell count (10000 points). Concomitant products included PRAVASTATIN and GEMFIBROZIL for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion hospitalization). The patient was hospitalized on 21-Mar-2021 due to PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown. Not Provided          Patient was treated with Levaquin, IV hydration with magnesium.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded	No current illness for this event.	1235518-1	Unknown	2021/04
47	MODERNA	Pneumonia; Slept almost all day; Left arm swollen; Hot above the site of injection; Entire body really aching; Redness on the site of injection; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leukemia in 2011. Concurrent medical conditions included Hearing impaired. Concomitant products included LATANOPROST for Glaucoma, DORZOLAMIDE and VITAMINS NOS from an unknown date to 03-Apr-2021 for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced SOMNOLENCE (Slept almost all day), PERIPHERAL SWELLING (Left arm swollen), VACCINATION SITE WARMTH (Hot above the site of injection), PAIN (Entire body really aching), VACCINATION SITE ERYTHEMA (Redness on the site of injection) and FATIGUE (Tiredness). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), SOMNOLENCE (Slept almost all day), PERIPHERAL SWELLING (Left arm swollen), VACCINATION SITE WARMTH (Hot above the site of injection), PAIN (Entire body really aching), VACCINATION SITE ERYTHEMA (Redness on the site of injection) and FATIGUE (Tiredness) outcome was unknown.            Treatment for the event included paracetamol. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.	Hearing impaired	1241376-1	80+ years	2021/04
48	MODERNA	1/5 vaccination.  Dizziness / light headiness; getting weaker. PCM wanted to run blood work.  1/14 blood panel / CBC.  *1958 Hospital diagnosed me with  '5th Leukemia'; anemic.  **I do have records if would like me to provide.	n/a	1243466-1	80+ years	2021/04
49	MODERNA	Tested positive for Covid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for Covid) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphatic leukemia.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for Covid) (seriousness criterion hospitalization). The patient was hospitalized for 10 days due to COVID-19. At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.  There is very limited information provided in this case as temporal association cannot be established due to missing therapy and onset date.  However, based on the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely.; Sender's Comments: There is very limited information provided in this case as temporal association cannot be established due to missing therapy and onset date.  However, based on the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely.	No current illness for this event.	1249662-1	Unknown	2021/04
50	MODERNA	Mass on Kidney; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of RENAL MASS (Mass on Kidney) in a 77-year-old female patient who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included Thyrotoxicosis with goiter (Thyrotoxicosis with diffuse goiter without thyrotoxic crisis). Concurrent medical conditions included Sulfonamide allergy (Allergic to sulfa antibiotics) and Chronic lymphocytic leukemia (Chronic Lymphocytic Leukemia of B cell type not having achieved remission). Concomitant products included IBRUTINIB (IMBRUVICA) from 10-Dec-2016 to 23-May-2018 for Chronic lymphocytic leukemia, PARACETAMOL (TYLENOL), METHIMAZOLE, VITAMIN D NOS, ATORVASTATIN CALCIUM, GABAPENTIN, LIDOCAINE, METOPROLOL TARTRATE, OXYCODONE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL MASS (Mass on Kidney) (seriousness criteria hospitalization). At the time of the report, RENAL MASS (Mass on Kidney) outcome was unknown.        For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Based on current available information and the temporal Association between product use and the start date of the events a causal relationship is unlikely. Very little information is available for review. Further information has been requested.; Sender's Comments: Based on current available information and the temporal Association between product use and the start date of the events a causal relationship is unlikely. Very little information is available for review. Further information has been requested.	Chronic lymphocytic leukemia (Chronic Lymphocytic Leukemia of B cell type not having achieved remission); Sulfonamide allergy (Allergic to sulpha antibiotics)	1261547-1	65-79 years	2021/04
51	MODERNA	Since my husband has had the vaccine he constantly has bad headaches and nausea.  NOT even a little bit had he anything close to this.  We are worried about this and I've been thinking and thinking as at our age and his leukemia it is scary.  He was worried enough that in the middle of moving to Fl from Ut he found a oncologist to make sure was not anything to do with cancer.  We can get the medical information concerning that visit if necessary but really getting concerned this is a temporary illness as been to long	No current illness for this event.	1289956-1	60-64 years	2021/05
52	MODERNA	Hyponatremia; Fever; This case was received via  (Reference number: 21k-163-3866645-00) on 23-Apr-2021 and was forwarded to Moderna on 05-May-2021.    This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of HYPONATRAEMIA (Hyponatremia) and PYREXIA (Fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENETOCLAX ABBVIE) tablet for Acute myeloid leukemia.    Patient's medical history was not provided by the reporter.  Concomitant products included ALLOPURINOL, HYDROXYUREA, INSULIN DETEMIR (LEVEMIR), ROSUVASTATIN, GABAPENTIN, LEVOTHYROXINE, VALSARTAN and PARACETAMOL (TYLENOL) for an unknown indication.   On 02-Apr-2021, the patient started VENETOCLAX (VENETOCLAX ABBVIE) (Oral) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced HYPONATRAEMIA (Hyponatremia) (seriousness criterion hospitalization). On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization). The patient was hospitalized on sometime in April 2021 due to HYPONATRAEMIA and PYREXIA. At the time of the report, HYPONATRAEMIA (Hyponatremia) and PYREXIA (Fever) had not resolved.            No treatment information was provided.  Very limited information regarding the events has been provided at this time. Additional information regarding name of the vaccine and date of administration, and date of onset for the events are required for further evaluation.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time. Additional information regarding name of the vaccine and date of administration, and date of onset for the events are required for further evaluation.	No current illness for this event.	1294096-1	Unknown	2021/05
53	MODERNA	Decreased WBC count; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (Decreased WBC count) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 036B21A) for COVID-19 vaccination.     The patient's past medical history included White blood cell count high (high white blood cell count of 65,000 before receiving the vaccine). Concurrent medical conditions included Chronic lymphocytic leukemia.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WHITE BLOOD CELL COUNT DECREASED (Decreased WBC count) (seriousness criterion medically significant). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (Decreased WBC count) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: 44000 (Inconclusive) 1-2 weeks after getting the 1st dose and 36000 (Inconclusive) 1-2 weeks after getting the 2nd dose.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.	Chronic lymphocytic leukemia	1298894-1	65-79 years	2021/05
54	MODERNA	Patient admitted to hospital after 2-3 days of shortness of breath and calf pain, swelling in foot distal to calf with pain.  Admission date 4/23, vaccinated with second moderna dose on 4/12 Two clots identified: right lower extremity DVT ""Positive study for acute DVT in the right lower extremity, extending from  the calf veins up through the right external iliac vein.   Positive study for acute superficial thrombophlebitis involving the  imaged lesser saphenous vein.""  and PE: ""Acute pulmonary embolism involving the main pulmonary arteries (saddle  pulmonary embolism) and extending to the lobar, segmental branches  bilaterally with some extension of the subsegmental branches in the right  lower lobe, overall worse in the right lower lobe with occlusive  segmental branches. ""  Was initially started on lovenox when admitted, switched to Eliquis, no IVC filter was placed discharged in stable condition on 4/26,   Of note: Patient had bone marrow biopsy of right iliac crest of April 15th 2021 - carries diagnosis of chronic lymphocytic leukemia but is currently in remission""	No current illness for this event.	1300022-1	60-64 years	2021/05
55	MODERNA	fluid overload; fatigue; Swollen lymph nodes; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FLUID OVERLOAD (fluid overload) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukaemia.    Concurrent medical conditions included Allergic reaction to drug, Chronic lymphocytic leukemia, Blood pressure high, Swollen lymph nodes, Swelling, Fatigue, Allergy to chemicals and Fruit allergy (Cantaloupes). Concomitant products included ATENOLOL for Blood pressure high, COENZYME Q10 [UBIDECARENONE], TURMERIC [CURCUMA LONGA RHIZOME], SELENIUM, VITAMIN D3, VITAMIN B COMPLEX, CALCIUM and FISH OIL for Supplementation therapy.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On 03-Apr-2021, the patient experienced FLUID OVERLOAD (fluid overload) (seriousness criterion hospitalization). The patient was hospitalized from 03-Apr-2021 to 05-Apr-2021 due to FLUID OVERLOAD. At the time of the report, FLUID OVERLOAD (fluid overload) was resolving and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Weight: 182 pounds 182 Pounds. On an unknown date, Weight: 194 pounds 194 Pounds.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated, the patient had been taking Imbruvica for the treatment of chronic lymphocytic leukemia for almost one month, but he complained that the drug had not helped to reduce the swelling, which might be caused by swollen lymph nodes. The swelling started before he started to take Imbruvica. The patient also said that the Imbruvica had not helped with his fatigue. He emphasized that he had no side effects from Imbruvica. On 03-Apr-2021, the patient was hospitalized for fluid overload, and 4.9 liters of fluid was removed from his body. He was discharged on 05-Apr-2021 to go home with a prescription of furosemide, to be taken orally daily, for the treatment of fluid overload. When he was admitted to the hospital, he weighed 194 pounds. When he was discharged from the hospital, he weighed 182 pounds. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The chronic lymphocytic leukemia is a cofounder; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The chronic lymphocytic leukemia is a cofounder	Allergic reaction to drug; Allergy to chemicals; Blood pressure high; Chronic lymphocytic leukemia; Fatigue; Fruit allergy (Cantaloupes); Swelling; Swollen lymph nodes	1301804-1	80+ years	2021/05
56	MODERNA	4/28 H&P: HPI: Hx obatined form chart review and wife. 58 y/o male patient with history of B-cell lymphoblastic leukemia who was treated with hyper CVAD then dasatinib  s/p allogenic stem cell transplant in 2018 on remission and cGVH 5/19/2020 requiring prednisone 5 mg daily on chronic acyclovir, bactrim and fluconazole who follows up at UM with Dr., also pt with hx of hypothyroidism, hyperlipidemia and hyponatremia presented today complaining of weakness for the last 2 days and headache the day prior to admission. Pt was taking Tylenol for the headache, and per wife he had a temp of 99 F. Denies any GI, urinary or abdominal symptom. Pt was being treated for a toe infection (ingrown toenail) with clindamycin. Pt travel during the weekend for 2 days where he did not have contact with any infected person. Pt is compliant with his medications and follows for his medical care. Today at the ED pt was having headache and during the afternoon started with AMS, became agitated, with upper extremity tremors and nuchal rigidity. Ct head did not showed any acute abnormality. However, pt developed a fever. LP was performed pending results. Started on empiric treatment for meningitis: vancomycin, acyclovir and ceftriaxone. MICU was called to admit patient due to worsening of mental status. PMH: hyperlipidemia, primary hypothyroidism, hx ALL s/p bone marrow transplant and cGVH. Allergies: denies. Medications:  Acyclovir 800 mg BID, amlodipine 5 mg daily, fluconazole 200 mg BID, levothyroxine 175 mcg, pantoprazole, prednisone 5 mg daily, bactrim 1 tab 3 times a week, terbinafine cream and triamcinolone.  Social: form Miami. No hx of alcohol, smoking. Physical Exam: Nursing note and vitals reviewed. Constitutional: Vital signs are normal. Pt lethargic, disoriented, no following commands w/o respiratory distress. HENT: Head: Normocephalic and atraumatic. Eyes: Conjunctivae and EOM are normal. Neck: No JVD present. Cardiovascular: Regular rhythm, normal heart sounds and intact distal pulses. Exam reveals no friction rub. No murmur heard. Pulmonary/Chest: Effort normal and breath sounds normal. No respiratory distress. He has no wheezes. He has no rales. He exhibits no tenderness. Abdominal: Bowel sounds are normal. There is no abdominal tenderness. There is no rebound and no guarding. Lymphadenopathy:  He has no cervical adenopathy. Neurological: Disoriented. Nuchal rigidity. Resting tremors. Hyperreflexia lower extremities. No clonus. Does not follow commands. Moves 4 extremities. Skin: Skin is warm.   4/29 ID note: 58yo M patient who comes with CC of 2 days of weakness and 1 day of headache. Progressive onset and no other associated symptoms, weakness referred as generalized by wife and headache really started on day of admission. He has an important history of B-cell lymphoblastic leukemia diagnosed 03/12/2018 ( +), treated with 2 cycles of hyperCVAD, and desatinib (latter stopped on 02/22/21 due to fluid retention), on remission. s/p allogenic stem cell transplant on 08/21/18 (CMV +/+) from brother (10/10 donor), which engrafted 09/01/2018. And chronic graft vs host disease diagnosed on 05/19/20 due to scleroderma of bl upper extremities, elevated LFTs and swelling of upper and lower extremities with decreased ROM, started on steroid initially 40mg bid and eventually 5mg qd since 03/16/21 He was on prophylaxis with Acyclovir, Bactrim 1 tab 3 times a week, and Fluconazole. In the ED patient found to be initially alert and oriented, but during the day became more agitated, eventually having altered mental status and becoming non verbal. He also presented fever. On evaluation physical exam showed a patient making incoherent sounds, with tremors which stopped, increased muscle tone and some rigidity and increased reflexes, nystagmus, not following command but retracting extremities when touched or moved, with possible kernig and brudzinski signs. Started on Ceftriaxone, Vancomycin and Acyclovir and changed to Cefepime, Vancomycin, Ampicillin and Acyclovir by MICU team. Acyclovir changed to Ganciclovir by ID. CSF without pleocytosis, normal glucose and only mild elevated protein. CT and MRI without acute findings. Assessment: 58yo M patient with history of ALL in 2018 s/p Allo-SCT (CMV+/+) at UM 2018, and complicated by chronic GVHD, currently on prednisone 5mg daily and prophylaxis with Bactrim three times a week, Acyclovir and Fluconazole, who presented with headache, fever and generalized weakness for 2 days. Became encephalopathic and was admitted to MICU. 1. Meningoencephalitis in immunocompromised patient - No changes since yesterday, leukocytosis 15.22 and Tmax 100.2- Negative HIV, RPR, - Culture CSF NGTD, Blood culture negative day 1, respiratory panel negative- Repeat LP- Pending additional studies, 2. Other problems- Hypothyroidism- Hyperlipidemia- Hyponatremia- Toe infection (ingrown nail) - 01/2021- CKD II and congenital solitary kidney -Baseline Cr 1.3 Plan: - Continue Ampicillin, Cefepime, Vancomycin and Ganciclovir- In process CSF HSV 1/2, CMV, culture- Ordered serum VZV,Crypoptococcus, Fungitell, Galactomannan, West Nile IgM, CMV PCR- Ordered Quantiferon-Gold- Needs LP and CSF - Measure opening pressure, Encephalitis panel, cryptococcus, Fungal, AFB, viral  culture, HHV6 PCR, EBV DNA PCR, VZV PCR, West Nile virus, Adenovirus, NMDA- Plan for LP today, family agreed.   5/3 ICU update: Patient has been accepted at where he is well known to the heme/onc service.  Will transfer today.	Pt was being treated for a toe infection (ingrown toenail) with clindamycin	1302850-1	50-59 years	2021/05
57	MODERNA	Vaccination adverse reaction; White blood cell count low; Fever; shaking; chills; vomiting; White blood Cell count low; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (White blood cell count low), WHITE BLOOD CELL COUNT DECREASED (White blood Cell count low), PYREXIA (Fever), TREMOR (shaking), CHILLS (chills), VOMITING (vomiting) and VACCINATION COMPLICATION (Vaccination adverse reaction) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Acute myeloid leukemia. Concomitant products included VENETOCLAX (VENCLEXTA) for Acute myeloid leukemia, APIXABAN (ELIQUIS), FLUOXETINE HYDROCHLORIDE (PROZAC), ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]), METRONIDAZOLE (FLAGYL [METRONIDAZOLE]), ALPRAZOLAM (XANAX), OXYCODONE, TRAZODONE, POSACONAZOLE (NOXAFIL), LEVOFLOXACINE [LEVOFLOXACIN] and SENNA ALEXANDRINA (SENNA PLUS [SENNA ALEXANDRINA]) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced WHITE BLOOD CELL COUNT DECREASED (White blood Cell count low) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization), TREMOR (shaking) (seriousness criterion hospitalization), CHILLS (chills) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). In April 2021, the patient experienced WHITE BLOOD CELL COUNT DECREASED (White blood cell count low) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to CHILLS, PYREXIA, TREMOR, VACCINATION COMPLICATION, VOMITING and WHITE BLOOD CELL COUNT DECREASED. At the time of the report, WHITE BLOOD CELL COUNT DECREASED (White blood cell count low) and WHITE BLOOD CELL COUNT DECREASED (White blood Cell count low) had not resolved, PYREXIA (Fever), TREMOR (shaking), CHILLS (chills) and VOMITING (vomiting) had resolved and VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: wbc decreased (Low) white blood cell count low. In March 2021, Body temperature: 103 (Inconclusive) 103 no unit. In April 2021, Blood test: wbc decreased (Low) white blood cell count low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was treated with Flagyl and Demrol.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.	No current illness for this event.	1309305-1	65-79 years	2021/05
58	MODERNA	hallucinating; Couln't walk; Can barely move; feels awful; chills; fever; This spontaneous case was reported by an other caregiver and describes the occurrence of HALLUCINATION (hallucinating) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic lymphocytic leukemia.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant), GAIT INABILITY (Couln't walk), HYPOKINESIA (Can barely move), VACCINATION COMPLICATION (feels awful), CHILLS (chills) and PYREXIA (fever). At the time of the report, HALLUCINATION (hallucinating), GAIT INABILITY (Couln't walk), HYPOKINESIA (Can barely move), VACCINATION COMPLICATION (feels awful), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Concomitant medication was not reported.  Treatment of these events were not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The past medical history of Chronic lymphocytic leukemia is a likely confounder the events described   This case was linked to MOD-2021-104070 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The past medical history of Chronic lymphocytic leukemia is a likely confounder the events described	Chronic lymphocytic leukemia	1312881-1	65-79 years	2021/05
59	MODERNA	ED Discharged  4/4/2021 (4 hours) Hospital Emergency Department  Last attending ? Treatment team Generalized weakness +4 more Clinical impression Weakness - Generalized ? Chills Chief complaint ED Provider Notes Emergency Medicine Expand AllCollapse All      HPI      Chief Complaint Patient presents with ? Weakness - Generalized ? Chills     HPI 79-year-old female, history of COPD for which she wears oxygen at night and as needed, also with a history of leukemia and obesity who presents to the ED complaining of generalized body aches, fevers up to 103, feeling generally unwell and weak, poor sleep, onset 3 to 4 days ago.  Patient reports that she received her second COVID-19 vaccine approximately 1 week ago.  Tolerated this without any particular symptoms.  She has had 2 days of watery/nonbloody diarrhea.  Does admit to nausea with several episodes of vomiting earlier today.  She is denying any particular abdominal pain.  Does believe she felt her urine burning earlier today but has had no gross hematuria.  Denies any flank pain.  No ill contacts although her husband has been at home with a slight cough.  Patient does have a cough presently but it is nonproductive.  She is denying any particular chest pain or subjective shortness of breath.  No rash or unusual lower extremity pain, swelling, or redness.    ED to Hosp-Admission Discharged  4/6/2021 - 4/17/2021 (11 days) Hospital  Last attending ? Treatment team Severe sepsis (CMS/HCC) Principal problem Discharge Summary Internal Medicine    Inpatient DeathSummary   BRIEF OVERVIEW Admission Date: 4/6/2021     Discharge Date: 4/17/2021  DETAILS OF HOSPITAL STAY   Presenting Problem/History of Present Illness/Reason for Admission Patient is an 79 y.o. female morbidly obese with past medical history of chronic lymphocytic leukemia follow-up that was initially scheduled oncology follow-up for April 7 now postponed to the next 2 weeks, COPD on 2 L oxygen support at home, GERD, depression and anxiety.  She was recently seen in the ED on April 4, 2021 with complaint of shortness of breath, nonproductive cough, fever, chills, nonbloody diarrhea, vomiting and weakness and subsequently diagnosed with COVID-19.  She had however received a second dose of COVID-19 a week before and was  discharged home due to lack of significant findings on imaging chest x-ray and lack of requirement for higher  oxygen support. She presented to the emergency via EMS for evaluation of progressive shortness of breath with associated with fever, chills, headache, persistent shortness of breath, cough productive of thick clear sputum, nausea, vomiting and diarrhea.  She denies abdominal pain, chest pain, or dizziness.  Denies recent antibiotic usage or recent travel.  Apparently, she thought she was getting better upon discharge after being kept for about 12 hours in the last ED visit, however she was not feeling well after going to bed last night and asked the husband to call 911.  Upon EMS arrival patient was saturating in the 80s and in respiratory distress.  She received 1 DuoNeb and was eventually placed on 10 L oxygen support.  She was noted to be in significant respiratory distress during speech.   Hospital Course Patient was admitted to hospital due to shortness of breath, and was found to have severe sepsis on presentation due to COVID-19 pneumonia.  She had evidence of acute on chronic hypoxic respiratory failure as well.  She was started on IV antibiotics, as well as remdesivir and Decadron at high dose.   Unfortunately she continued to have clinical deterioration, and ultimately required high flow oxygen therapy.  She was then transferred to the ICU, and ultimately required intubation due to severe profound ongoing hypoxia despite optimal medical treatment.  She did not respond to remdesivir or steroids or antibiotics.  Post intubation, she also developed acute renal failure during the course of her admission.   Multiple discussions were had throughout the hospitalization regarding goals of care, and initially patient and family wish to be continually aggressive.  She received full medical treatment, including life support, with minimal improvement.  Despite being on ventilator for roughly 5 days, she continued to have severe hypoxia.  She was proned, and was unable to sustain oxygen saturations when supine even for short period.   Her renal function continued to decline as well, and at that point discussion was had with family regarding goals of care again.  They were explained that symptoms continue to be persistent, and her illness continues to progress despite aggressive medical therapy.  Ultimately decision was made to not pursue dialysis, and to allow the patient to be kept comfortable and pass away naturally from this infection.   She was terminally extubated on 4/17 and passed away at 11:16 AM due to COVID-19 and acute on chronic hypoxic respiratory failure.   Operative Procedures Performed X-ray Abdomen 1 View   Result Date: 4/13/2021 Narrative: Single view portable abdomen INDICATION: Nasogastric tube placement, encounter initial Supine portable view of the lower chest and abdomen demonstrates nasogastric tube with tip and side-port in the gas-distended stomach. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient.   X-ray Chest 1 View   Result Date: 4/16/2021 Narrative: XR CHEST 1 VW IMPRESSION: No significant change from the previous examination. END OF IMPRESSION: INDICATION: Worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/13/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. Right-sided chest tube is unchanged. There is a small left pleural effusion. There is diffuse bilateral hazy airspace opacification. No change from prior. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient.   X-ray Chest 1 View   Result Date: 4/15/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Tubes and lines as described. Small left effusion. Unchanged patchy bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/14/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. The right-sided chest tube is unchanged. There is no pneumothorax. There is a small effusion. There is diffuse bilateral patchy airspace consolidation. There is no significant change. Cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient.   X-ray Chest 1 View - Daily   Result Date: 4/14/2021 Narrative: Chest radiograph HISTORY: Covid 19 infection. Mechanical ventilation. Comments: Frontal radiograph of the chest was obtained and compared to the prior study dated 4/13/2021. The heart is at the upper limits of normal. The mediastinum is within normal limits. Interstitial alveolar opacities are demonstrated bilaterally consistent with pneumonia. There is an endotracheal tube with the distal end approximately 4.3 cm from the carina. Nasogastric tube is noted directed towards the stomach. There is a right jugular central catheter. A right-sided pigtail catheter is seen. IMPRESSION: 1. Persistent bilateral interstitial alveolar opacities consistent with pneumonia. 2. Lines and tubes in place as described. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient.   X-ray Chest 1 View, Portable   Result Date: 4/14/2021 Narrative: PROCEDURE INFORMATION: Exam: XR Chest Exam date and time: 4/13/2021 11:46 PM Age: 79 years old Clinical indication: Hypoxia; Covid+ TECHNIQUE: Imaging protocol: XR of the chest. Views: 1 view. COMPARISON: DX XR CHEST 1 VW 4/13/2021 10:50 AM FINDINGS: Tubes, catheters and devices: Endotracheal tube tip located at the level of the carina. Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. Nasogastric tube enters the stomach but tip not included on the image. Tip of right internal jugular central venous catheter in SVC. Cardiac leads superimposed over the chest bilaterally. Lungs: Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. Pleural spaces: Small right apical pneumothorax (12 mm). New small left pleural fluid collection. No right pleural fluid collection. Heart/Mediastinum:  Stable cardiac silhouette Bones/joints: Unremarkable for age. IMPRESSION: 1.  Endotracheal tube tip located at the level of the carina. 2.  Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. 3.  Small right apical pneumothorax (12 mm). 4.  Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. 5.  New small left pleural fluid collection. 6.  No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD   X-ray Chest 1 View, Portable   Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT INDICATION: verify placement of right chest tube.  Encounter: Subsequent. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: Earlier today. FINDINGS: The left thoracostomy tube terminates near the lateral right midlung. No other change. Extensive pulmonary infiltrates. Stable life support lines. The previous right pneumothorax has predominantly resolved, only a thin crescent of air caps the right apex. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient.   X-ray Chest 1 View, Portable   Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Lines as described. There is a small right-sided pneumothorax. Unchanged bilateral airspace consolidation. END OF IMPRESSION: INDICATION: verify placement of CVC and post intubation. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/11/2021. FINDINGS: There is a right IJ central venous catheter. Tip is projected over the SVC. There is a small right apical pneumothorax. Endotracheal tube terminates 2 cm superior to the carina. The nasogastric tube passes beneath the diaphragm. Multifocal areas of patchy airspace consolidation bilaterally. Findings do not appear significantly changed from prior. The cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient.   X-ray Chest 1 View   Result Date: 4/11/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Mildly worsened bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening respiratory failure, covid pneumonia worsening respiratory failure, covid pneumonia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/8/2021. FINDINGS: The left costophrenic angle is partially excluded. The lungs are adequately expanded. There are large areas of patchy airspace consolidation bilaterally. Findings have mildly increased in severity. There is no effusion or pneumothorax. The cardiac silhouette is mildly enlarged. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient.   X-ray Chest 1 View   Result Date: 4/8/2021 Narrative: XR CHEST 1 VW PORT INDICATION: Worsening hypoxemia, Covid pneumonia.  Encounter: Initial. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: 4/4/2021. FINDINGS: Scattered pulmonary infiltrates is developed bilaterally, greatest in the right upper and right lower lobe. No change in the heart, mediastinum, or bony thorax. IMPRESSIONS: Developing pulmonary infiltrates. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient.   X-ray Chest 1 View - Portable   Result Date: 4/4/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: No evidence of acute pulmonary disease. END OF IMPRESSION: INDICATION: SOB, weak, cough SOB, weak, cough. TECHNIQUE: Portable AP projection of the chest is acquired. COMPARISON: 6/5/2020 FINDINGS: Heart size appears unremarkable. There is mild prominence of pulmonary arteries. This is stable. There is no focal consolidation or effusion. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient.   Transthoracic Echo (tte) Complete   Result Date: 4/11/2021 Narrative: Gender: Female Age: 79 Procedure Date: 4/11/2021 10:19 AM Study Quality: Fair Ht / Wt / BSA: 66.00 in /  218.00 lb /  2.07 m2 Heart Rate: 77 bpm BP: 181 / 81 mmHg Indications: Arrhythmia           Transthoracic 2D, Color Flow, and Doppler Echocardiogram      Conclusions: The left ventricle is normal in size.          Ejection Fraction 55% (normal range 50-70%).   All wall segments showed normal motion.        Mild concentric LVH.                           Trivial aortic regurgitation.                  No additional significant valvular abnormality. No prior study for comparison.                 Presentation and History: Indication: The patient presents for evaluation of arrhythmia.  The patient has a history of obesity and chronic obstructive pulmonary disease. Findings: Procedure Information: Contrast agent, definity, is being given per protocol without apparent complications.  Due to technical limitations in the assessment of the left ventricle, imaging was performed after the administration of intravenous Definity echocontrast, as per protocol. Left Ventricle: The left ventricle is normal in size.  There is mildly increased left ventricular wall thickness.  The left ventricular systolic function is normal.  The visually estimated ejection fraction is 55% (normal range 50 70%). Wall Motion: All wall segments showed normal motion. Right Ventricle: RV not well visualized.  RV grossly normal in size and function by subcostal view. Atria: The left atrium is borderline dilated.  The right atrium is normal in size. Aortic Valve: Sclerotic appearing aortic valve with no significant aortic stenosis. Trivial aortic regurgitation. Mitral Valve: There is trace mitral valve regurgitation by color flow and doppler analysis.  There is no mitral valve stenosis by color flow and doppler analysis. Pulmonic Valve: There is no evidence of significant pulmonic valvular stenosis or insufficiency by color flow and doppler analysis. Tricuspid Valve: There is trace tricuspid valve regurgitation by color flow and doppler analysis. Great Vessels: All visible segments of the aorta are normal in size. Venous: The inferior vena cava is normal in size and collapses greater than 50% with inspiration. Pericardium/Pleural: There is no evidence of pericardial effusion. Prior Study Comparison: No prior study for comparison.                                             Measurements: Left Ventricle: IVSd: 0.85 cm (0.6-0.9/0.6-1.0) LVIDd: 5.10 cm (3.9-5.3/4.2-5.9) LVIDd Index: 2.46 cm/m2 (2.4-3.2/2.2-3.1) LVIDs: 3.56 cm (2.0-3.6) LVPWd: 0.95 cm (0.7-1.1) Ao Root: 3.30 cm (2.1-3.5) LV Mass: 203.25 g (67-162/88-224) LV Mass Index: 98.19 g/m2 (43-95/49-115) LVOT Diam: 1.90 cm (3.0+(-)1.3) LVOT Pk Vel: 0.91 LVOT Mn Vel: 0.63 LVOT VTI: 0.20 LVOT Pk Grad: 3.00 LVOT Mn Grad: 2.00 LVOT Diam: 1.90 LVOT Area: 2.84 MV Pk E: 0.66 MV Pk A: 0.66 E/A: 1.00 E'Medial: 5.33 E/E' Med: 12.30 E' Laterial: 10.60 E/E' Lat: 6.20   Mitral Valve: MV Pk E: 0.66 MV PK A: 0.66 MV Decel Time: 209.00 E/A: 1.00 E'Lateral: 10.60 E'Medial: 5.33 E/E' Med: 12.30 E/E' Lat: 6.20 PHT: 61.00 MVA PHT: 3.61 Decel Slope: 3.14   Aortic Valve: AoV Pk Vel: 1.65 AoV Mn Vel: 1.22 AoV VTI: 0.39 AoV Pk Grad: 11.00 Aov Mn Grad: 7.00 AVA Cont.VTI: 1.42  Tricuspid Valve: TR Pk Vel: 2.89 TR Pk Grad: 33.00 RA Press: 10.00 RVSP: 43.00   Great Vessels: Ao Root-2D: 3.30 cm (2.0-3.7) Ao Asc: 3.30 cm (2.1-3.4)      Updated on 4/11/2021 5:10:04 PM with Status of Final           electronically signed on 4/11/2021 5:10:04 PM with status of Final                                         Ct Covid Chest Low Dose Without Contrast   Result Date: 4/6/2021 Narrative: PROCEDURE INFORMATION: Exam: CT Chest Without Contrast; Diagnostic Exam date and time: 4/6/2021 4:21 AM Age: 79 years old Clinical indication: Cough and shortness of breath; Patient HX: +covid; Additional info: Cough. Shortness of breath, covid TECHNIQUE: Imaging protocol: Diagnostic computed tomography of the chest without contrast. 3D rendering (Not supervised by radiologist): MIP and/or 3D reconstructed images were created by the technologist. Radiation optimization: All CT scans at this facility use at least one of these dose optimization techniques: automated exposure control; mA and/or kV adjustment per patient size (includes targeted exams where dose is matched to clinical indication); or iterative reconstruction. COMPARISON: CT CHEST WO CONTRAST 3/8/2021 2:28 PM FINDINGS: Lungs: There are patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. Pleural spaces: Unremarkable. No pneumothorax. No pleural effusion. Heart: No cardiomegaly. No pericardial effusion. Aorta: Atherosclerotic changes of the aorta. Lymph nodes: Unremarkable. No enlarged lymph nodes. Bones/joints: Unremarkable. No acute fracture. Soft tissues: Unremarkable. IMPRESSION: Patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD	No current illness for this event.	1313931-1	65-79 years	2021/05
60	MODERNA	Moderna COVID-19 Vaccine EUA.  The vaccine activated a latent Chronic Myelo Monocyte Leukemia (CMML)   The evening of the vaccine I became very fatigued and was freezing.  (A topcoat was donned and I went to bed early. ) By day three the freezing dissipated; however, the fatigue di not.  After three weeks of fatigue my physician ordered several blood analyses.  High monocytes counts (4.0) and low Platelet counts (105) were revealed.   I was referred to a hematologist who ordered a bone marrow biopsy.  It revealed CMML 1.  A A review of 18 years of monocyte and platelet showed the monocyte counts were hovering at the maximum and platelet counts hovering at the minimum until 03/29/2021 when they escalated to the counts reported above.	facial spasm probable regeneration of trigeminal nerve	1327760-1	65-79 years	2021/05
61	MODERNA	Detached retina; low blood count on and off; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL DETACHMENT (Detached retina) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Weight gain in November 2019. Concurrent medical conditions included Hypothyroidism since 2018, Metastatic breast cancer since November 2019, Chronic lymphocytic leukemia since 2005 and Glaucoma since 2016. Concomitant products included PALBOCICLIB (IBRANCE) for Metastatic breast cancer.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2020, the patient experienced BLOOD COUNT ABNORMAL (low blood count on and off). On 06-Apr-2021, the patient experienced RETINAL DETACHMENT (Detached retina) (seriousness criterion medically significant). The patient was treated with Surgery for Retinal detachment. At the time of the report, RETINAL DETACHMENT (Detached retina) was resolving and BLOOD COUNT ABNORMAL (low blood count on and off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Blood count: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient started palbociclib in Nov-2019; and she had a low blood count on and off. After a year, they moved her from 125 milligrams capsules to the 100 milligrams tablets and then everything was fine. The last time it went low was right around the time she got the Moderna vaccine. The patient's  counts went down after the vaccine but then they went right back up. Her doctor said she was much improved at the next blood draw and maybe her body was just trying to fight off the vaccine. On 06 Apr 2021, the patient had the detached retina. No concomitant medications reported.  The patient underwent surgery for detached retina.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.	Chronic lymphocytic leukemia; Glaucoma; Hypothyroidism; Metastatic breast cancer	1334854-1	65-79 years	2021/05
62	MODERNA	COVID-19, Pneumonia, Mucus discharge, Nauseous, COVID-19 recurrent; pneomonia; Mucus discharge; COVID-19 recurrent; nausea; headache; body ache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19, Pneumonia, Mucus discharge, Nauseous, COVID-19 recurrent) and PNEUMONIA (pneomonia) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukemia.    No Medical History information was reported.   On 10-Apr-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 140 mg twice a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced COVID-19 (COVID-19, Pneumonia, Mucus discharge, Nauseous, COVID-19 recurrent) (seriousness criterion hospitalization) and PNEUMONIA (pneomonia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced SECRETION DISCHARGE (Mucus discharge), COVID-19 (COVID-19 recurrent), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body ache). The patient was hospitalized from 08-Jan-2021 to 12-Jan-2021 due to COVID-19. On 13-Jan-2021, COVID-19 (COVID-19, Pneumonia, Mucus discharge, Nauseous, COVID-19 recurrent) and PNEUMONIA (pneomonia) was resolving. At the time of the report, SECRETION DISCHARGE (Mucus discharge), COVID-19 (COVID-19 recurrent), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Had CT scan 2 weeks ago, which is clean and clear.. On an unknown date, Coronavirus test: positive (Positive) Covid-19 test positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication information provided.  Patient had COVID in January, was hospitalized for 5 days, lost his sense of smell and taste, which hasn't fully recovered, but is feeling better and still had fatigue. Patient had pneumonia with shortness of breath which is dissipating. Patient had taken Moderna covid vaccines, stated reactions with first time felt like he had covid again for a couple of days, and the second one gave him headaches and body aches for a day. Patient stated  his doctor says he did build up immunity from vaccine, noted from test. The medication was held when had covid for a week or two.   No relevant treatment medication information provided.  Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273. Very limited information regarding these event (pneumonia and other events) has been provided at this time. However, it is not clear if COVID-19 and pneumonia occurred prior to 1st dose of mRNA-1273.; Sender's Comments: Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273. Very limited information regarding these event (pneumonia and other events) has been provided at this time. However, it is not clear if COVID-19 and pneumonia occurred prior to 1st dose of mRNA-1273.	No current illness for this event.	1345838-1	65-79 years	2021/05
63	MODERNA	71 y.o. male with history of leukemia who presents accompanied by his son with complaints of 6 week history of generalized weakness worsening over time accompanied by loss of appetite and weight loss. He reports receiving his initial COVID vaccine 6 weeks ago and symptoms began immediately following this. He denies pain or SOB.   Pt with severe protein calorie malnutrition and AML presented with dehydration from MRSA Sepsis. Pt had weakness from dehydration, malnutrition and sepsis. He had a progressive downhill course. His family elected for comfort measures. He died of his illness and was pronounced dead at 4:13AM April 13, 2021	See chronic/long standing conditions	1354838-1	65-79 years	2021/05
64	MODERNA	Patient recevied COVID vaccine and while waiting in lobby became lethargic, clammy, discolored, and was unconcious for about 30 seconds Mother states first vaccine he did not get a reaction just was sleepy. Stated he had Leukemia and has been in remission for the last 10 years.	none, per mother	1355782-1	18-29 years	2021/05
65	MODERNA	diagnosed with leukemia; open wounds on her legs; This spontaneous case was reported by a consumer and describes the occurrence of LEUKAEMIA (diagnosed with leukemia) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus syndrome and Atrial fibrillation. Concomitant products included METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced WOUND (open wounds on her legs). On 14-Mar-2021, the patient experienced LEUKAEMIA (diagnosed with leukemia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 11-Mar-2021 due to LEUKAEMIA. At the time of the report, LEUKAEMIA (diagnosed with leukemia) and WOUND (open wounds on her legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Biopsy bone marrow: bone marrow was tested. On 14-Mar-2021, Biopsy bone marrow: leukemia.         Treatment information not reported.   Concomitant medications also included heart med, but full list not reported.  On an unknown date, after the 1st dose, patient had blood work done. After the 2nd dose, patient was then admitted to the hospital on 11-MAR-2021 due to the weird blood test results.  Company comments: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.	No current illness for this event.	1359985-1	65-79 years	2021/05
66	MODERNA	Admit 5/17. Vaccine 2/10. CHief complaint in ED lower back pain. Hx of Leukemia, degenerative disc disease. Developed high feveral. Admit COVID PNA. Elavated LFT, inflammatory markers. Neg CXR, CT shows lower lobe PNA. Treated w/antibiotics, steroid. Remained asymptomatic respiratory wise, stable on RA. DCd to home	No current illness for this event.	1368493-1	60-64 years	2021/06
67	MODERNA	Tuesday morning on 01/23/2021 I checked on my mother and she was sitting on toilet and couldn't get up. She had caked blood in her mouth, and a lot of bruising. She had been on the toilet since the night before on 01/22/2021 at  9:30PM until 7:30 AM in the morning. EMS came and they took her to the hospital. They did blood work, chest x-ray, MRI. She was admitted for four days 01/23/2021-01/26/2021. During that period she did find out she has acute lymphoblastic leukemia. She saw the oncologist on February 1 and admitted again on February 2. On that hospital stay they did more blood work and more treatment. She started vincristine, steroids, and other cancer drugs and she had a lot of tests done everyday. That hopsital stay was from 02/02/2021-02/26/2021.	None.	1371656-1	80+ years	2021/06
68	MODERNA	CMML cases that have undergone clinical progression; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of CHRONIC MYELOMONOCYTIC LEUKAEMIA (CMML cases that have undergone clinical progression) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic myelomonocytic leukemia.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHRONIC MYELOMONOCYTIC LEUKAEMIA (CMML cases that have undergone clinical progression) (seriousness criterion medically significant). At the time of the report, CHRONIC MYELOMONOCYTIC LEUKAEMIA (CMML cases that have undergone clinical progression) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time.; Sender's Comments: This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time.	Chronic myelomonocytic leukemia	1375714-1	Unknown	2021/06
69	MODERNA	neuropathy; Numbness in left leg; Pain in Left leg; Swollen LN in groin; hard time breathing; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphoma (stage 4 lymphoma) on 18-Aug-2018, Leukemia and Back surgery. Concurrent medical conditions included Leg pain. Concomitant products included AMLODIPINE and ATENOLOL for Hypertension, ONDANSETRON for Nausea, PREGABALIN (LYRICA) for Nerve pain, ZINC for Supplementation therapy, MULTIVITAMIN [VITAMINS NOS] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 21-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (neuropathy) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in left leg), PAIN IN EXTREMITY (Pain in Left leg), LYMPHADENOPATHY (Swollen LN in groin), DYSPNOEA (hard time breathing) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (neuropathy), HYPOAESTHESIA (Numbness in left leg), PAIN IN EXTREMITY (Pain in Left leg), LYMPHADENOPATHY (Swollen LN in groin), DYSPNOEA (hard time breathing) and FATIGUE (fatigue) outcome was unknown.            Patient also undergone to Chemotherapy, radiation.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-MAY-2021 and events are updated with patient historical condition; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.	No current illness for this event.	1380709-1	50-59 years	2021/06
70	MODERNA	Experienced loss of appetite.  Weakness.  Started with pelvic soreness and pain increased where patient couldn't walk.  Admitted to Emergency Room and diagnosed with Acute Lymphoblastic leukemia.	No current illness for this event.	1392407-1	65-79 years	2021/06
71	MODERNA	Saddle Pulmonary Embolism; DVT; This spontaneous case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Saddle Pulmonary Embolism) and DEEP VEIN THROMBOSIS (DVT) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UBLITUXIMAB for an unknown indication, UMBRALISIB for an unknown indication and VENETOCLAX for an unknown indication.    Concurrent medical conditions included Hypertension, Mantle cell lymphoma, Leukemia (relapsed or refractory CLL/SLL) and Richter's syndrome.   On 28-May-2020, the patient started UBLITUXIMAB (Intravenous) 900 milligram and UMBRALISIB (Oral) 800 milligram. On 02-Sep-2020, the patient started VENETOCLAX (Oral) 400 milligram. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criteria hospitalization and medically significant). On 24-Apr-2021, the patient experienced PULMONARY EMBOLISM (Saddle Pulmonary Embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 23-Apr-2021 to 26-Apr-2021 due to DEEP VEIN THROMBOSIS and PULMONARY EMBOLISM. The patient was treated with HEPARIN on 23-Apr-2021 for DVT, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Saddle Pulmonary Embolism) and DEEP VEIN THROMBOSIS (DVT) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Ultrasound scan: dvt (abnormal) Ultrasound of lower right extremity showed acute deep vein thrombosis, DVT.. On 24-Apr-2021, Computerised tomogram: saddle pulmonary embolism (abnormal) CT on chest with IV contrast showed a saddle pulmonary embolism ..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.	Hypertension; Leukemia (relapsed or refractory CLL/SLL); Mantle cell lymphoma	1401708-1	60-64 years	2021/06
72	MODERNA	I experience face and ear swollen. Couldn't chew. Since vaccination I been diagnosis with A-Fib and Lymphocytic Leukemia.	No.	1406711-1	65-79 years	2021/06
73	MODERNA	Leukemia diagnosed April 2021 after ~1 mo of fatigue, bruising	none	1418096-1	50-59 years	2021/06
74	MODERNA	Pt with no active medical problems other than diet controlled diabetes had his Moderna COVID vaccines 02/16 and 03/16/2021. He presented to the hospital with c/o 2 mo (since around 4/14) of progressive fatigue and weakness which progressed to dizziness and now shortness of breath the past month and was found to have profound pancytopenia. He had no history of alcohol use, b 12 or folate deficiancy, no recent illness, no medications, HIV and hepatitis testing were negative. He does not smoke. He had no prior history of problems with his white blood cell count, red blood cell count or platelet count. He admitted that shortly after his second vaccine he began to feel fatgiued with symptoms progressing afterwards. Upon admission his hemoglobin was 6.7 and he was given 2 units of blood. His D-dimer was elevated at 1224 and a CTA of the chest was negative for PE.  His PT/INR PTT were within normal limits EKG showed no acute ischemia and normal sinus rhythm.  Fibrinogen was 246.  His iron was 238 saturation of 77 TIBC of 309 and ferritin of 941.    His hemoglobin A1c was 6.0.  He was seen during his hospital stay by Hematology/oncology . vitamin B12 and folate levels were normal.    He has no prior history of malignancy.  Patient's ultrasound of the abdomen showed no splenomegaly.  Again vitamin B12 and folic acid levels were normal.  A peripheral blood smear was done which was concerning per oncology for an underlying bone marrow condition. Ultimately his bone marrow biopsy showed Acute myeloid leukemia with blasts and monocyte features.	None	1425042-1	65-79 years	2021/06
75	MODERNA	Pancreatitis; Flank Pain; Allergic reaction; Abdominal Pain; Pain; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of PANCREATITIS (Pancreatitis) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukemia and SEMAGLUTIDE (OZEMPIC) for an unknown indication.    Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), EMPAGLIFLOZIN (JARDIANCE) and METOPROLOL for an unknown indication.   On 20-Dec-2017, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 140 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, IBRUTINIB (IMBRUVICA) (Oral) 280 milligram once a day and SEMAGLUTIDE (OZEMPIC) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS (Pancreatitis) (seriousness criterion medically significant), FLANK PAIN (Flank Pain), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash). At the time of the report, PANCREATITIS (Pancreatitis), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash) outcome was unknown and FLANK PAIN (Flank Pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.	Chronic lymphocytic leukemia	1435903-1	60-64 years	2021/06
76	MODERNA	On Feb 18th had sores on her tongue. Three days later had a inflame throat. On March 11th the inside of her left cheek had a large blister. Developed neutropenia April 26th. On May 7th developed leukemia.	none	1437986-1	50-59 years	2021/06
77	MODERNA	My husband passed away June 3, 2021 resulting from complications which began a few hours after receiving his 2nd Moderna shot on April 29, 2021. He never tested positive for Covid19, however his first symptoms were the typical fever, muscle aches, rash. He declined daily from a host of mysterious symptoms including full body rash, blood clots, muscle spasms, atrial fibrillation, ulcers lining his esophagus and colon, and exorbitant WBC (157K) with extremely high eosinophils (90%). He was treated with a host of drugs including antibiotics, steroids, blood thinners, ivermectin and finally chemotherpay (Campath). His ICU team  included hematology, pulmonology, ... oncology and infectious disease. After an incredible amount of diagnostic testing ( daily routine blood work, EKGs, chest x-rays, CT scans, MRI, bone marrow biopsy, endoscopy, colonoscopy, skin biopsy, genetic testing) no definitive diagnosis could be made, however, he was given the possible diagnosis of chronic eosinophilia leukemia in late May. The big question among the medical staff was, ""Did the shot trigger something?"" He was eventually treated with the chemotherapy drug Campath, which reduced the WBC and EOs some, but his organs, especially, lungs had been very compromised by the high WBC and eosinophils. Several days after being placed on a ventilator and given a feeding tube at the end of May, a CT scan and MRI confirmed patient had suffered multiple strokes. He passed away a half hour after being taken off the ventilator the morning of June 3, 2021. His death certificate read:  A. cardiopulmonary arrest  B. acute hypoxic respiratory failure  C.  hypereosinophila""	tendonitis in elbow	1446639-1	60-64 years	2021/07
78	MODERNA	Pt received his moderna vaccines on 5/7/21 and 6/4/21. Prior to vaccination pt was working full time, active with no significant health concerns other than controlled blood pressure on 1 medication. After his first vaccine in the left arm he reported his arm was very sore, swollen, painful and red which lasted 3 days and he reported he could not move his arm due to pain. He reports for days after he then had extreme fatigue but then recovered and went on with his life. He got his 2nd dose of the vaccine on 6/4/21 and then was hospitalized on 6/16/21 with severe pancytopenia with pathology ultimately showing Acute myeloid leukemia, severe cellulitis of the L lower leg,  and  ultimately developed a left lower extremity deep vein thrombosis in that leg as well. Interestingly he injured his right leg just before vaccination and did not develop any cellulitis or poor healing  in that leg just a week before his first dose. He remains hospitalized in guarded condition as of 7/9/2021 currently receiving chemotherapy treatment with decitabine and venetoclax and has receving multiple transfusions of blood, antibiotics, steroids and now anticoagulation.	None	1459400-1	50-59 years	2021/07
79	MODERNA	Acute Lymphoblastic Leukemia, Ph- Began feeling tired and noticed becoming slightly out of breath within 2-3 weeks of 2nd dose.  First hospitalized on May 21 after blood work drawn on 5/20 showed hemoglobin below 5.  Nurse at BMT clinic on Sunday told him that he was the 2nd patient that day who mentioned getting leukemia after 2nd dose of Covid vaccine, which prompted this report.	No current illness for this event.	1465095-1	40-49 years	2021/07
80	MODERNA	After the second Moderna Covid shot patient had fatigue, malaise, his symptoms never improved they became worse. Since then he has been light headed, dizzy, some peripheral eye issues. He falls asleep in less than two minuets. He was told to give it some time that these were side effects from the Covid shot. He made an appointment with his primary doctor on June 10th, had several blood test done, many came back with extremely abnormal results. He was sent to an oncologist, the bone marrow aspiration revealed PH+Chronic Myloid Leukemia. Patient was very healthy prior to this, had had blood work within the previous year that was 100% normal at that time!!	None	1467508-1	65-79 years	2021/07
81	MODERNA	It's like experiencing dementia; Stiffness; Slight constipation; Nausea; Body aches (upper and lower body); Consistent headaches (front and back of head); Scratchy throat; Needle pain after the injection; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (It's like experiencing dementia) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Acute lymphoblastic leukemia (Acute Lymphoblastic Leukemia  with radiation treatment therapy to brain and central nervous system.) since 1972 and Immunocompromised (Patient belongs to ""Immunocompromised population"".). Concomitant products included MULTIVITAMIN [VITAMINS NOS] and DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]) for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Needle pain after the injection). On 24-Jun-2021, the patient experienced THROAT IRRITATION (Scratchy throat). On an unknown date, the patient experienced DEMENTIA (It's like experiencing dementia) (seriousness criteria hospitalization and medically significant), MUSCULOSKELETAL STIFFNESS (Stiffness), CONSTIPATION (Slight constipation), NAUSEA (Nausea), MYALGIA (Body aches (upper and lower body)) and HEADACHE (Consistent headaches (front and back of head)). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, DEMENTIA (It's like experiencing dementia), MUSCULOSKELETAL STIFFNESS (Stiffness), CONSTIPATION (Slight constipation), THROAT IRRITATION (Scratchy throat), NAUSEA (Nausea), MYALGIA (Body aches (upper and lower body)), HEADACHE (Consistent headaches (front and back of head)) and VACCINATION SITE PAIN (Needle pain after the injection) outcome was unknown.            The patient stated that he has no history of any illicit drugs use, marijuana, or tobacco.  Company Comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Very limited information regarding the event Dementia has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-235743 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Very limited information regarding the event Dementia has been provided at this time.  Further information has been requested.""	Acute lymphoblastic leukemia (Acute Lymphoblastic Leukemia  with radiation treatment therapy to brain and central nervous system.); Immunocompromised (Patient belongs to ""Immunocompromised population"".)""	1481719-1	50-59 years	2021/07
82	MODERNA	Low blood pressure; Sweating; Concussion; Diarrhea; Irregular menstrual cycle; Lightheadedness; Dehydrated; Heart pounding; Fever; Covid arm of left arm which was hard in between elbow and shoulder; like hives and was pink; like hives and was pink; Weakness; Eye discomfort; Fainted; Woke up covered in blood gashed forehead open above right eye; Stomach pain; Nausea; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) and HAEMORRHAGE (Woke up covered in blood gashed forehead open above right eye) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Chronic myeloid leukemia. Concomitant products included DASATINIB MONOHYDRATE (SPRYCEL) for Chemotherapy, VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced HAEMORRHAGE (Woke up covered in blood gashed forehead open above right eye) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NAUSEA (Nausea). On 09-Jun-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant). On an unknown date, the patient experienced PALPITATIONS (Heart pounding), ASTHENIA (Weakness), OCULAR DISCOMFORT (Eye discomfort), HYPOTENSION (Low blood pressure), HYPERHIDROSIS (Sweating), CONCUSSION (Concussion), DIARRHOEA (Diarrhea), MENSTRUATION IRREGULAR (Irregular menstrual cycle), DIZZINESS (Lightheadedness), DEHYDRATION (Dehydrated), PYREXIA (Fever), VACCINATION SITE INDURATION (Covid arm of left arm which was hard in between elbow and shoulder), VACCINATION SITE ERYTHEMA (like hives and was pink) and VACCINATION SITE URTICARIA (like hives and was pink). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SYNCOPE (Fainted), HAEMORRHAGE (Woke up covered in blood gashed forehead open above right eye), PALPITATIONS (Heart pounding), ABDOMINAL PAIN UPPER (Stomach pain), ASTHENIA (Weakness), OCULAR DISCOMFORT (Eye discomfort), INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPOTENSION (Low blood pressure), HYPERHIDROSIS (Sweating), CONCUSSION (Concussion), MENSTRUATION IRREGULAR (Irregular menstrual cycle), DIZZINESS (Lightheadedness), DEHYDRATION (Dehydrated), NAUSEA (Nausea), PYREXIA (Fever), VACCINATION SITE INDURATION (Covid arm of left arm which was hard in between elbow and shoulder), VACCINATION SITE ERYTHEMA (like hives and was pink) and VACCINATION SITE URTICARIA (like hives and was pink) outcome was unknown and DIARRHOEA (Diarrhea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 67/30 (Low) 67/30. On an unknown date, Heart rate: low (Low) Low.         Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-253122 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.	Chronic myeloid leukemia	1481773-1	40-49 years	2021/07
83	MODERNA	patient reports that she started with reactivation of cancer symptoms (Chronic lymphocytic leukemia ) after Moderna Covid vaccine	UNKNOWN	1485034-1	65-79 years	2021/07
84	MODERNA	Within 4-6 weeks of the second vaccine, patient started showing signs of shortness of breathe, swollen feet, cough, weak muscles, tired and no energy. patient had been walking with walker up to that point 5 times a week for 15-20 minutes. Since these symptoms began, he was not been able to walk more than a few feet without resting and being out of breath.  He had been put on a diuretic and inhaler which didn't seem to be doing much. He saw his primary and heart Dr since the beginning of June. On June 24th he was admitted into the Hospital with Congestive Heart Failure. After blood tests, he was also diagnosed with Leukemia. A week later, on July 1, 2021, patient passed away.	No current illness for this event.	1485987-1	80+ years	2021/07
85	MODERNA	patient says after her 2 shot covid 19 vaccine series her leukemia numbers went up and have since come back down.	CML	1509485-1	65-79 years	2021/07
86	MODERNA	I have a small tumor on pancreas; dark urine; Blond stools; yellowing skin; hilar cholangio carcinoma; small tumor on my liver; Persistent itching all over body/Itching moves; This spontaneous case was reported by a consumer and describes the occurrence of CHOLANGIOCARCINOMA (hilar cholangio carcinoma) and HEPATIC NEOPLASM (small tumor on my liver) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic leukemia, Bile duct cancer and Liver spots (Spot on liver).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced PRURITUS (Persistent itching all over body/Itching moves). On an unknown date, the patient experienced CHOLANGIOCARCINOMA (hilar cholangio carcinoma) (seriousness criterion medically significant), HEPATIC NEOPLASM (small tumor on my liver) (seriousness criterion medically significant), PANCREATIC NEOPLASM (I have a small tumor on pancreas), CHROMATURIA (dark urine), FAECES DISCOLOURED (Blond stools) and YELLOW SKIN (yellowing skin). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, CHOLANGIOCARCINOMA (hilar cholangio carcinoma), HEPATIC NEOPLASM (small tumor on my liver), PRURITUS (Persistent itching all over body/Itching moves), PANCREATIC NEOPLASM (I have a small tumor on pancreas), CHROMATURIA (dark urine), FAECES DISCOLOURED (Blond stools) and YELLOW SKIN (yellowing skin) outcome was unknown.            No concomitant medication reported.  Treatment included, anti-histamines couple of times a day and  steroids prescribed by the doctor was reported  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Cholangiocarcinoma, Hepatic neoplasm and Pancreatic neoplasm which could not have been caused by the vaccine and had to be pre-existing along with the patient's statement that they had GI symptoms pre-dating the first vaccine.   This case was linked to MOD21-035148 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up document contains new events.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Cholangiocarcinoma, Hepatic neoplasm and Pancreatic neoplasm which could not have been caused by the vaccine and had to be pre-existing along with the patient's statement that they had GI symptoms pre-dating the first vaccine. MOD21-035148:	Bile duct cancer; Chronic leukemia; Liver spots (Spot on liver)	1514445-1	65-79 years	2021/07
87	MODERNA	Following second dose on 4/8, developed low grade fevers and fatigue around 4/23/21. Labs showed elevated LFTs, anemia and thrombocytopenia. Bone marrow biopsy on 6/30/21 showed acute myelomonocytic leukemia.	No current illness for this event.	1528639-1	65-79 years	2021/08
88	MODERNA	Sore; A spontaneous report was received from a consumer concerning, a male patient who received Moderna's COVID-19 vaccine and experienced being sore.  The patient's medical history included Chronic lymphocytic leukemia (CLL). Concomitant medication used by the patient within two weeks prior to the event included intravenous immune globulin (IVIG).     On 28-Dec-2020, the patient received their first of two planned doses of mRNA-1273, intramuscularly in the left arm for prophylaxis of COVID-19 infection. Following his first vaccine dose, patient stated no symptoms, just sore. Treatment information was not provided. There was no change planned to the dosing schedule of mRNA-1273 in response to the event, sore.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, sore was not reported.   The reporter assessed the event sore as related to study drug.; Reporter's Comments: This case concerns a male patient of unknown age, who experienced a non-serious unexpected event of Pain after receiving the first dose of mRNA-1273, lot # unknown. Treatment was not reported. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.	Chemotherapy NOS; CLL	1536851-1	Unknown	2021/08
89	MODERNA	I sit right now the left side of my pelvis hurts; lost my sence of taste and smell; lost my sence of taste and smell; felt feverish; fatigued; headache; lethargic; moving slow or "" 60 year old feeling more like 75 years old""/wasn't as mobile as he normally was; hacking up a lot of phlegm; just wasn't feeling good; back and pelvis pain that has lasted for 2 to 3 weeks; This spontaneous case was reported by an other health care professional and describes the occurrence of LETHARGY (lethargic), MOBILITY DECREASED (moving slow like "" 60 year old feeling more like 75 years old""/wasn't as mobile as he normally was), PRODUCTIVE COUGH (hacking up a lot of phlegm), MALAISE (just wasn't feeling good) and BACK PAIN (back and pelvis pain that has lasted for 2 to 3 weeks) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (Cancer Survivor CML) in 2000, Leukemia, Glaucoma and Heart rate (unspecified). Concomitant products included DORZOLAMIDE and TRAVOPROST (TRAVATAN Z) for Glaucoma, VERAPAMIL for Heart rate, IMATINIB MESILATE (GLEEVEC) and FILGRASTIM (NEUPOGEN) for Leukemia, MAGNESIUM OXIDE (MAG OXIDE) and CALCIUM CITRATE for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced LETHARGY (lethargic), MOBILITY DECREASED (moving slow like "" 60 year old feeling more like 75 years old""/wasn't as mobile as he normally was), PRODUCTIVE COUGH (hacking up a lot of phlegm), MALAISE (just wasn't feeling good), BACK PAIN (back and pelvis pain that has lasted for 2 to 3 weeks), PYREXIA (felt feverish), FATIGUE (fatigued) and HEADACHE (headache). On 04-Jan-2021, the patient experienced AGEUSIA (lost my sence of taste and smell) and ANOSMIA (lost my sence of taste and smell). On an unknown date, the patient experienced PELVIC PAIN (I sit right now the left side of my pelvis hurts). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pyrexia, Fatigue, Back pain, Pelvic pain, Headache, Malaise, Lethargy, Mobility decreased and Productive cough, at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargic), MOBILITY DECREASED (moving slow like "" 60 year old feeling more like 75 years old""/wasn't as mobile as he normally was), PRODUCTIVE COUGH (hacking up a lot of phlegm), MALAISE (just wasn't feeling good), BACK PAIN (back and pelvis pain that has lasted for 2 to 3 weeks), PELVIC PAIN (I sit right now the left side of my pelvis hurts), PYREXIA (felt feverish), FATIGUE (fatigued) and HEADACHE (headache) outcome was unknown and AGEUSIA (lost my sence of taste and smell) and ANOSMIA (lost my sence of taste and smell) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Second dose details were added On 15-Apr-2021: Reporter details updated and new events were added""	No current illness for this event.	1543295-1	60-64 years	2021/08
90	MODERNA	Severe Sweating; Eyes were bloodshot red; headache; injection arm burning; Felt really fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Severe Sweating), OCULAR HYPERAEMIA (Eyes were bloodshot red), HEADACHE (headache), INJECTION SITE PAIN (injection arm burning) and FATIGUE (Felt really fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Severe Sweating), OCULAR HYPERAEMIA (Eyes were bloodshot red), HEADACHE (headache), INJECTION SITE PAIN (injection arm burning) and FATIGUE (Felt really fatigue). At the time of the report, HYPERHIDROSIS (Severe Sweating), OCULAR HYPERAEMIA (Eyes were bloodshot red), HEADACHE (headache), INJECTION SITE PAIN (injection arm burning) and FATIGUE (Felt really fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact	No current illness for this event.	1544580-1	50-59 years	2021/08
91	MODERNA	chills; high fever of 100.3.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (high fever of 100.3.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Leukemia lymphocytic chronic and COVID-19 in December 2020.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (high fever of 100.3.). At the time of the report, CHILLS (chills) and PYREXIA (high fever of 100.3.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-017163 (Patient Link).	No current illness for this event.	1548329-1	65-79 years	2021/08
92	MODERNA	Elevated WBC; Elevated Platelets; Elevated Absolute Lymphocytes; Felt sleepy all day; Felt bad; No hunger; hives the size of a dollar bill; felt lump on the left arm; Redness; Itchiness; Little soreness injection arm; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (Elevated WBC), PLATELET COUNT INCREASED (Elevated Platelets), LYMPHOCYTE COUNT INCREASED (Elevated Absolute Lymphocytes), SOMNOLENCE (Felt sleepy all day) and FEELING ABNORMAL (Felt bad) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Acute myeloid leukemia (brother, sister and niece died due to Acute myeloid leukemia (AML) blast). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced INJECTION SITE PAIN (Little soreness injection arm). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Elevated WBC), PLATELET COUNT INCREASED (Elevated Platelets), LYMPHOCYTE COUNT INCREASED (Elevated Absolute Lymphocytes), SOMNOLENCE (Felt sleepy all day), FEELING ABNORMAL (Felt bad), APPETITE DISORDER (No hunger), URTICARIA (hives the size of a dollar bill), VACCINATION SITE MASS (felt lump on the left arm), ERYTHEMA (Redness) and PRURITUS (Itchiness). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (Elevated WBC), PLATELET COUNT INCREASED (Elevated Platelets), LYMPHOCYTE COUNT INCREASED (Elevated Absolute Lymphocytes), SOMNOLENCE (Felt sleepy all day), FEELING ABNORMAL (Felt bad), APPETITE DISORDER (No hunger), URTICARIA (hives the size of a dollar bill), VACCINATION SITE MASS (felt lump on the left arm) and INJECTION SITE PAIN (Little soreness injection arm) outcome was unknown and ERYTHEMA (Redness) and PRURITUS (Itchiness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Lymphocyte count: high (High) High. In 2021, Platelet count: high (High) High. In 2021, White blood cell count: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment medication included Benadryl (diphenhydramine) and Prednisone.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Followup information was received on 30-Mar-2021 reporter details, medical history, laboratory data concomitant medication and events were captured.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested	No current illness for this event.	1551059-1	65-79 years	2021/08
93	MODERNA	area is a 3 inch x 5 inch patch on muscle around the injection site; njection site became itchy; injection site became warm; fever; pink at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), VACCINATION SITE ERYTHEMA (pink at injection site), VACCINATION SITE PRURITUS (njection site became itchy), VACCINATION SITE WARMTH (injection site became warm) and VACCINATION SITE RASH (area is a 3 inch x 5 inch patch on muscle around the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Leukaemia. Concomitant products included natural hormone replacement, LEVOTHYROXINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), PROBIOTIC 10, sambucol elderberry gummy and super beet chew for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PYREXIA (fever) and VACCINATION SITE ERYTHEMA (pink at injection site). On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (njection site became itchy) and VACCINATION SITE WARMTH (injection site became warm). On 02-Feb-2021, the patient experienced VACCINATION SITE RASH (area is a 3 inch x 5 inch patch on muscle around the injection site). At the time of the report, PYREXIA (fever), VACCINATION SITE ERYTHEMA (pink at injection site) and VACCINATION SITE WARMTH (injection site became warm) had resolved and VACCINATION SITE PRURITUS (njection site became itchy) and VACCINATION SITE RASH (area is a 3 inch x 5 inch patch on muscle around the injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment: Advil	Leukaemia	1551189-1	65-79 years	2021/08
94	MODERNA	Malaise; left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday; Itchy; nausea, could not eat; Fever; Nausea, could not eat; Headache; left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), PAIN IN EXTREMITY (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday), PRURITUS (Itchy), DECREASED APPETITE (nausea, could not eat) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00UM20A and 013C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic lymphocytic leukemia. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MALAISE (Malaise), PAIN IN EXTREMITY (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday), PRURITUS (Itchy), PYREXIA (Fever), NAUSEA (Nausea, could not eat), HEADACHE (Headache) and VACCINATION SITE SWELLING (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday). 16-Feb-2021, the patient experienced DECREASED APPETITE (nausea, could not eat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Feb-2021, PYREXIA (Fever) had resolved. On 21-Feb-2021, MALAISE (Malaise), DECREASED APPETITE (nausea, could not eat) and NAUSEA (Nausea, could not eat) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday) and PRURITUS (Itchy) had resolved and HEADACHE (Headache) and VACCINATION SITE SWELLING (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient is on medication centromine.  patient has received Tylenol and advil after both doses.	No current illness for this event.	1551423-1	65-79 years	2021/08
95	MODERNA	stomach pains; Bad reaction; vomiting; profusely sweating/head dripping with sweat; diarrhea; She reported left arm soreness; left arm swelling after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (She reported left arm soreness), VACCINATION SITE SWELLING (left arm swelling after vaccination), ABDOMINAL PAIN UPPER (stomach pains), ADVERSE REACTION (Bad reaction) and VOMITING (vomiting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic lymphocytic leukemia (Cancer diagnosis). Concurrent medical conditions included Penicillin allergy, Hypertension and High cholesterol. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA) and ACEBUTOLOL for BP raised, IBRUTINIB for Cancer, LOVASTATIN for High cholesterol.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (She reported left arm soreness) and VACCINATION SITE SWELLING (left arm swelling after vaccination). On 06-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pains), ADVERSE REACTION (Bad reaction), VOMITING (vomiting), HYPERHIDROSIS (profusely sweating/head dripping with sweat) and DIARRHOEA (diarrhea). On 07-Feb-2021, VACCINATION SITE PAIN (She reported left arm soreness), VACCINATION SITE SWELLING (left arm swelling after vaccination), ABDOMINAL PAIN UPPER (stomach pains), ADVERSE REACTION (Bad reaction), VOMITING (vomiting), HYPERHIDROSIS (profusely sweating/head dripping with sweat) and DIARRHOEA (diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.	No current illness for this event.	1555419-1	65-79 years	2021/08
96	MODERNA	big hard red spot on injection site; big hard red spot on injection site; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (big hard red spot on injection site), AXILLARY PAIN (sore arm), FATIGUE (fatigue) and VACCINATION SITE INDURATION (big hard red spot on injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia (Patient was treated for Leukemia) in November 2020.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 23-Jan-2021, the patient experienced AXILLARY PAIN (sore arm) and FATIGUE (fatigue). On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (big hard red spot on injection site) and VACCINATION SITE INDURATION (big hard red spot on injection site). The patient was treated with CORTISONE at an unspecified dose and frequency.   On 09-Feb-2021, VACCINATION SITE ERYTHEMA (big hard red spot on injection site) and VACCINATION SITE INDURATION (big hard red spot on injection site) had resolved. At the time of the report, AXILLARY PAIN (sore arm) and FATIGUE (fatigue) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.	No current illness for this event.	1556651-1	65-79 years	2021/08
97	MODERNA	tested positive for Covid on 03Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid on 03Feb2021) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia, Blood pressure high and Diabetes. Concomitant products included chemo therapy medication, OLMESARTAN, METFORMIN, FENOFIBRATE and ROSUVASTATIN for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid on 03Feb2021). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid on 03Feb2021) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.	No current illness for this event.	1557046-1	40-49 years	2021/08
98	MODERNA	Disgusted with the salty metallic taste in her mouth; Lost some weight; Feels depressed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSGEUSIA (Disgusted with the salty metallic taste in her mouth), WEIGHT DECREASED (Lose some weight) and DEPRESSION (Feels depressed) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukaemia.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Disgusted with the salty metallic taste in her mouth), WEIGHT DECREASED (Lose some weight) and DEPRESSION (Feels depressed). At the time of the report, DYSGEUSIA (Disgusted with the salty metallic taste in her mouth), WEIGHT DECREASED (Lose some weight) and DEPRESSION (Feels depressed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. The patient went to her dentist and doctor in regards to her reaction, but they are unsure of what caused it. Her sense of smell is fine and she had some blood work done (results are pending).	Chronic lymphocytic leukaemia	1559460-1	65-79 years	2021/08
99	MODERNA	slight cough; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), COUGH (slight cough) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy and Leukemia since 2010.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced COUGH (slight cough) and HEADACHE (headache). On 03-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, COUGH (slight cough) outcome was unknown and HEADACHE (headache) had not resolved.            No concomitant and treatment drugs were reported.   This case was linked to MOD-2021-030579, MOD-2021-030579 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Added address of the reporter, second dose of the drug, patient demographics (height, weight, race, allergy, current condition). Added the events (cough, headache).	Iodine allergy; Leukemia	1560224-1	65-79 years	2021/08
100	MODERNA	This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), FEELING HOT (very hot), ERYTHEMA (spread all the way down to her elbow), INJECTION SITE ERYTHEMA (red) and INJECTION SITE PAIN (tender to the touch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leukemia. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING HOT (very hot), ERYTHEMA (spread all the way down to her elbow), INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (tender to the touch) and INJECTION SITE SWELLING (swollen). On an unknown date, the patient experienced COUGH (coughing), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (coughing), FEELING HOT (very hot), ERYTHEMA (spread all the way down to her elbow), INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (tender to the touch), INJECTION SITE SWELLING (swollen), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported.	No current illness for this event.	1561039-1	65-79 years	2021/08
101	MODERNA	This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (couldn't move arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (It was mild COVID infection.) on 15-Mar-2020 and Leukemia. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced LIMB DISCOMFORT (couldn't move arm). At the time of the report, LIMB DISCOMFORT (couldn't move arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2020, Antibody test: (Positive) Tested positive for COVID antibody test. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.	No current illness for this event.	1561359-1	65-79 years	2021/08
102	MODERNA	Felt like a truck hit me for about 24 hours; temp went up to 101.1F; soreness in left arm; low grade fever; nauseous; vomiting; aches in legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aches in legs), FEELING ABNORMAL (Felt like a truck hit me for about 24 hours), PYREXIA (temp went up to 101.1F), MYALGIA (soreness in left arm) and PYREXIA (low grade fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acute myeloid leukemia (5 years remission.) since 15-Sep-2015. Concurrent medical conditions included Allergy (Scents and hayweed.). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), VALSARTAN for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID), ZOLPIDEM TARTRATE (AMBIEN), ALPRAZOLAM (XANAX) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 10-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (aches in legs), PYREXIA (temp went up to 101.1F), MYALGIA (soreness in left arm), PYREXIA (low grade fever), NAUSEA (nauseous) and VOMITING (vomiting). On an unknown date, the patient experienced FEELING ABNORMAL (Felt like a truck hit me for about 24 hours). At the time of the report, PAIN IN EXTREMITY (aches in legs), FEELING ABNORMAL (Felt like a truck hit me for about 24 hours), PYREXIA (temp went up to 101.1F), MYALGIA (soreness in left arm), PYREXIA (low grade fever), NAUSEA (nauseous) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up was received on 22 April 2021. Patient demographics , historical condition , concomitant medication, second dose information and new event ( feeling abnormal ) was added.	Acute myeloid leukemia (5 years remission.)	1561897-1	65-79 years	2021/08
103	MODERNA	Tooth extraction; Racing heart, heart rate was in the 130s; This spontaneous case was reported by an other health care professional and describes the occurrence of TOOTH EXTRACTION (Tooth extraction) and PALPITATIONS (Racing heart, heart rate was in the 130s) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chronic lymphocytic leukaemia, Heart rate abnormal in 2019, Dizziness in 2019, White blood cell count decreased in 2019, Laziness in 2019, Heart rate high (for about 3-4 min) in 2020, Glare in 2020 and Difficulty focusing eyes in 2020. Concomitant products included METOPROLOL SUCCINATE, IBRUTINIB (IMBRUVICA) from 29-Aug-2019 to an unknown date and IBRUTINIB for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TOOTH EXTRACTION (Tooth extraction) and PALPITATIONS (Racing heart, heart rate was in the 130s). At the time of the report, TOOTH EXTRACTION (Tooth extraction) and PALPITATIONS (Racing heart, heart rate was in the 130s) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include Baby Aspirin.	No current illness for this event.	1563326-1	65-79 years	2021/08
104	MODERNA	Heart racing; tooth extraction; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing) and TOOTH EXTRACTION (tooth extraction) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia, Heart rate abnormal (reported on 06-Nov-2019 that heart rate was in the 40s on an unknown date), Dizziness (reported on 06-Nov-2019 that he was experiencing some dizziness on an unknown date), Heart rate increased (reported by the patient on 24-Jun-2020; again reported on 30-Jun-2020 that he had been having episodes of the fast heart rate around every 3-4 weeks where it gets up to around 128 to 135 and lasts for about 3-4 minutes; again reported periodic heart rate increased by patient on 14-Jan-2021), Fatigue (reported by the patient on 24-Jun-2020), White blood cell count decreased (reported by the patient on 24-Jun-2020), Glare (reported on 30-Jun-2020) and Difficulty focusing eyes (reported on 30-Jun-2020). Concomitant products included METOPROLOL SUCCINATE, LEVOTHYROXINE SODIUM and ATORVASTATIN CALCIUM for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) 420 mg once a day. On an unknown date, the patient experienced PALPITATIONS (Heart racing) and TOOTH EXTRACTION (tooth extraction). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date for Heart racing and Tooth extraction, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart racing) and TOOTH EXTRACTION (tooth extraction) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that his heart rate was in the 130s and normally he runs in the 50-60s. He thought his heart racing was due to having large meals.   Reporter did not allow further contact	Chronic lymphocytic leukemia	1563428-1	80+ years	2021/08
105	MODERNA	Both of his ankles are swollen; Short of breath; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Both of his ankles are swollen) and DYSPNOEA (Short of breath) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stent insertion NOS (Patient has stent implanted in his left heart and one in his right leg.). Concurrent medical conditions included Leukemia.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced JOINT SWELLING (Both of his ankles are swollen) and DYSPNOEA (Short of breath). At the time of the report, JOINT SWELLING (Both of his ankles are swollen) and DYSPNOEA (Short of breath) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.  Patient stated that he was sleep sitting up in a chair   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15-Jun-2021 and does not contain any new information	Leukemia	1564125-1	65-79 years	2021/08
106	MODERNA	felling dizziness; Weakness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (felling dizziness) and ASTHENIA (Weakness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia stage 0 (under oncologist follow-up) and Blood pressure abnormal. Concomitant products included LISINOPRIL and AMLODIPINE for Blood pressure abnormal, IBRUTINIB (IMBRUVICA) for Chemotherapy.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021 at 11:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (felling dizziness) and ASTHENIA (Weakness). At the time of the report, DIZZINESS (felling dizziness) and ASTHENIA (Weakness) outcome was unknown.            The reporter stated that patient did not seem to be in extreme distress, so she was driving the patient to nearby emergency room (ER) to have checked at the time of this report. The reporter also stated that when patient developed symptoms, patient contacted her oncologist who recommended, not to take chemotherapy medications for 2 days (on the day of vaccination and next day). No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.	Blood pressure abnormal; Chronic lymphocytic leukemia stage 0 (under oncologist follow-up)	1564295-1	65-79 years	2021/08
107	MODERNA	Developed shingles on left side of body and on his back; A regulatory report was received from a Consumer concerning a 72 years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed shingles on the left side of body and on his back (Herpes zoster).  The patient's medical history includes numerous medical issues and leukemia for 16 years. The relevant concomitant medications reported were also not provided.  On 12 Feb 2021, prior to the onset of the event, the patient received his first dose of two planned vaccine doses of mRNA (Lot number: 031620A) through intramuscular route for prophylaxis of COVID-19 infection.  On 04 Mar 2021, patient developed shingles on the left side of body and on his back. The patient was taken to the clinic and was treated with Famvir 500 mg TID and Cortisone Cream.  No laboratory data was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, developed shingles on left side of body and on his back, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's underlying medical history of leukemia seems to be a strong confounding factor to the reported event.	Leukemia	1564646-1	65-79 years	2021/08
108	MODERNA	A lot of itching up to my forehead, sides of my head and down to my neck/It also concentrated in the right of my shoulder/It is going down to my elbows; It feels like hives on the top of my head; I couldn't sleep because of the itching; Rash in both shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A lot of itching up to my forehead, sides of my head and down to my neck/It also concentrated in the right of my shoulder/It is going down to my elbows), URTICARIA (It feels like hives on the top of my head), INSOMNIA (I couldn't sleep because of the itching) and RASH (Rash in both shoulder) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Previously administered products included for Pain: Cortisone shot (Patient got cortisone shot between the two shots. It was on the opposite arm and in his right shoulder) on 03-Mar-2021. Concurrent medical conditions included Pain (Patient had pain from another injury (fell)), Vitamin D low, Leukemia and Hypokalaemia. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PRURITUS (A lot of itching up to my forehead, sides of my head and down to my neck/It also concentrated in the right of my shoulder/It is going down to my elbows), URTICARIA (It feels like hives on the top of my head), INSOMNIA (I couldn't sleep because of the itching) and RASH (Rash in both shoulder). At the time of the report, PRURITUS (A lot of itching up to my forehead, sides of my head and down to my neck/It also concentrated in the right of my shoulder/It is going down to my elbows), URTICARIA (It feels like hives on the top of my head) and INSOMNIA (I couldn't sleep because of the itching) outcome was unknown and RASH (Rash in both shoulder) had not resolved.      Concomitant medications included medications for leukemia, low potassium, low vitamin D and pain. The patient stated 4 medications a day, 6-7 pills per day.   The patient's HCP recommended diphenhydramine and hydrocortisone cream to apply to the arm and shoulder. The patient had not started treatment at the time of this report.	Hypokalaemia; Leukemia; Pain (Patient had pain from another injury (fell)); Vitamin D low	1565768-1	65-79 years	2021/08
109	MODERNA	vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (vaccination adverse reaction) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukemia.    No Medical History information was reported.   On 28-Feb-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 140 milligram three times a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up information  received on 24-May-2021 contains non significant information. Possible NNI. On 28-May-2021: No new information provided.	No current illness for this event.	1565923-1	50-59 years	2021/08
110	MODERNA	lymph nodes on both arms are swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes on both arms are swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic leukemia.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph nodes on both arms are swollen). At the time of the report, LYMPHADENOPATHY (lymph nodes on both arms are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medication included an unspecified infusion for chronic leukemia.  Patient's lymph nodes on both arms were swollen about a week after vaccination. She did not took any treatment for the event.	Chronic leukemia	1567525-1	65-79 years	2021/08
111	MODERNA	This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme pain on the tips of his toes on the left foot/On a scale of 1-10 it was 10) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 018B21A) for COVID-19 vaccination.     The patient's past medical history included Vasculitis (In 1984 and 1988 he had hospitalization for vasculitis in fingertips and toes) in 1984 and Cyanosis (Vasculitis resulted in cyanosis of just tips of toes and fingers(1984 and 1988).) in 1984. Concurrent medical conditions included Atrial fibrillation, Chronic lymphocytic leukemia since 2011, Cholesterol (Borderline cholesterol), Stroke (Previous minor stroke), Hypothyroidism, Blood pressure since 2005, Penicillin allergy, Allergy to antibiotic (Allergy to Cephalosporins) and Allergy to antibiotic (Allergy to Avalox). Concomitant products included METOPROLOL TARTRATE for Blood pressure, LISINOPRIL for Blood pressure and Atrial fibrillation, ATORVASTATIN for Cholesterol, LEVOTHYROXINE for Hypothyroidism, APIXABAN (ELIQUIS) for Stroke.   On 25-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021 at 3:00 AM, the patient experienced PAIN (Extreme pain on the tips of his toes on the left foot/On a scale of 1-10 it was 10). On 26-Feb-2021 at 3:10 AM, PAIN (Extreme pain on the tips of his toes on the left foot/On a scale of 1-10 it was 10) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported. Patient has stated that in 1984 and 1988 he had episodes with toe and finger tip it became infarcted and felled of dead tissues and he had resolved with residual effects of damage of finger and toe tips.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Added secondary reporter details, Added concomitant medication information. On 30-Jul-2021: Added patient details, patient's other relevant history were added, Added Concomitant medications and its indication.	Allergy to antibiotic (Allergy to Cephalosporins); Allergy to antibiotic (Allergy to Avalox); Atrial fibrillation; Blood pressure; Cholesterol (Borderline cholesterol); Chronic lymphocytic leukemia; Hypothyroidism; Penicillin allergy; Stroke (Previous minor stroke)	1567566-1	65-79 years	2021/08
112	MODERNA	dizziness; fatigue; nausea; Pregnancy; sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy), VACCINATION SITE PAIN (sore arm), DIZZINESS (dizziness), FATIGUE (fatigue) and NAUSEA (nausea) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 030A21A) for COVID-19 vaccination.     No medical history was provided.  The patient's past medical history included Acute lymphoblastic leukemia (In remission since 1996) in 1992, Alcohol use (4 drinks per week) from 2009 to 21-Jan-2021 and Marijuana use (1 gram per month) from 2008 to 21-Jan-2021. Concurrent medical conditions included Sulfonamide allergy and Migraine (Improvement since pregnancy) since 2007. Concomitant products included PRENATAL MULTIVITAMIN + DHA from 25-Jan-2021 to an unknown date for Prenatal care.   On 01-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 23-Dec-2020 and the estimated date of delivery was 12-Sep-2021. On 01-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (sore arm). On 02-Mar-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (fatigue) and NAUSEA (nausea). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Mar-2021, DIZZINESS (dizziness), FATIGUE (fatigue) and NAUSEA (nausea) had resolved. On 03-Mar-2021, VACCINATION SITE PAIN (sore arm) had resolved. On 26-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Pregnancy test: positive (Positive) positive. On 30-Jan-2021, Ultrasound scan: positive (Positive) positive pregnancy. On 16-Jun-2021, Blood glucose: negative (Negative) negative for gestational diabetes. On 29-Apr-2022, Ultrasound foetal: normal (normal) anatomy scan- normal, no findings.         On 01mar2021, post vaccination, the patient reported that she experienced symptoms of dizziness, fatigue, nausea, vaccination site pain and exposure during pregnancy.   No treatment information was provided  Internal review on 21jul2021 resulted in updates to pregnancy information   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Internal reviewon 21jul2021 resulted in updates to pregnancy information	Migraine (Improvement since pregnancy); Sulfonamide allergy	1570856-1	30-39 years	2021/08
113	MODERNA	Brown spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Brown spot) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Brown spot). At the time of the report, VACCINATION SITE RASH (Brown spot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment details were not reported by the reporter.	Leukemia	1572381-1	80+ years	2021/08
114	MODERNA	Dizzy; uncoordinated; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and COORDINATION ABNORMAL (uncoordinated) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J2OA) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia. Concomitant products included METFORMIN, HYDROXYUREA, IRON and ALOGLIPTIN for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced DIZZINESS (Dizzy) and COORDINATION ABNORMAL (uncoordinated). At the time of the report, DIZZINESS (Dizzy) and COORDINATION ABNORMAL (uncoordinated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received and contains No new information	Leukemia	1572774-1	65-79 years	2021/08
115	MODERNA	Had soreness for a few hours but it went away the same day; Achiness; Malaise; She also had some chills; Low grade fever that went up and down that night around 17:00; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Had soreness for a few hours but it went away the same day), PAIN (Achiness), MALAISE (Malaise) and CHILLS (She also had some chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphatic leukemia (Oncologist said she got it because she was not taking any cancer medications.). Concomitant products included FAMOTIDINE (PEPCID AC) for Esophagitis and Gastritis, LEVOTHYROXINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN (Had soreness for a few hours but it went away the same day), PAIN (Achiness), MALAISE (Malaise) and CHILLS (She also had some chills). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of UNK dosage form. On 29-Jan-2021, PAIN (Had soreness for a few hours but it went away the same day) had resolved. On 31-Jan-2021, PAIN (Achiness), MALAISE (Malaise) and CHILLS (She also had some chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.	Chronic lymphatic leukemia (Oncologist said she got it because she was not taking any cancer medications.)	1573316-1	65-79 years	2021/08
116	MODERNA	soreness at the injection site; bone pain; my teeth hurt; my skin hurt; I had muscle pain; felt winded; mentally foggy; diarrhea; nausea; vomited once; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to Moderna on 02-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (soreness at the injection site), BONE PAIN (bone pain), TEETHING (my teeth hurt), PAIN OF SKIN (my skin hurt) and MYALGIA (I had muscle pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leukemia (Has been in remission for many years).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced ARTHRALGIA (soreness at the injection site), BONE PAIN (bone pain), TEETHING (my teeth hurt), PAIN OF SKIN (my skin hurt), MYALGIA (I had muscle pain), ASTHENIA (felt winded), FEELING ABNORMAL (mentally foggy), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomited once). At the time of the report, ARTHRALGIA (soreness at the injection site), BONE PAIN (bone pain), TEETHING (my teeth hurt), PAIN OF SKIN (my skin hurt), MYALGIA (I had muscle pain), ASTHENIA (felt winded), FEELING ABNORMAL (mentally foggy), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomited once) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. concomitant information was not provided.   Reporter did not allow further contact	No current illness for this event.	1580781-1	50-59 years	2021/08
117	MODERNA	Swollen arm; it had a big red spot; it was itchy; A spontaneous report was received from an other healthcare concerning a 71 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen arm/peripheral swelling, it had a big red spot/rash macular, it was itchy/pruritus.   The patient's medical history included chronic lymphocytic leukemia. Products known to have been used by the patient, within two weeks prior to the event, included fluoxetine hydrochloride and centromine.    The patient received their first of two planned doses of mRNA-1273 (Batch number: 013C20A) on 19 Jan 2021 in the left arm for prophylaxis of COVID-19 infection.   Ten days after receiving the vaccine patient experienced swollen arm, it had a big red spot, it was itchy. Treatment for the event included Paracetamol and Ibuprofen.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The events swollen arm, it had a big red spot and it was itchy was resolved on unknown date.	No current illness for this event.	1580874-1	65-79 years	2021/08
118	MODERNA	Improvement of rash (that was present for years); itching; The rash completely disappeared; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and RASH (The rash completely disappeared) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia and Rash (Rash from the leukemia for several years. After he received the 1st dose of the Moderna Covid-19 vaccine, the rash started to improved and stop itching. The rash completely disappeared 4 - 5 days after receiving the 2nd dose of the vaccine.).   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (itching) and RASH (The rash completely disappeared). At the time of the report, PRURITUS (itching) and RASH (The rash completely disappeared) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up information received  21-JUN-2021 contain Race information of patient.	No current illness for this event.	1594661-1	65-79 years	2021/08
119	MODERNA	terrible sweating to the point where I almost wet a bed; Suspected COVID-19; fever of 101 F; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (terrible sweating to the point where I almost wet a bed), SUSPECTED COVID-19 (Suspected COVID-19) and PYREXIA (fever of 101 F) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia since an unknown date and Coronavirus test positive in July 2020. Concomitant products included GABAPENTIN, TAMSULOSIN, IBRUTINIB (IMBRUVICA), ATORVASTATIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), GLIPIZIDE, ZINC and ASCORBIC ACID (VITAMIN C ACID).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 24-Feb-2021, the patient experienced HYPERHIDROSIS (terrible sweating to the point where I almost wet a bed), SUSPECTED COVID-19 (Suspected COVID-19) and PYREXIA (fever of 101 F). On 25-Feb-2021, HYPERHIDROSIS (terrible sweating to the point where I almost wet a bed), SUSPECTED COVID-19 (Suspected COVID-19) and PYREXIA (fever of 101 F) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (terrible sweating to the point where I almost wet a bed), PYREXIA (fever of 101 F) and INFLUENZA LIKE ILLNESS (He felt like he had a Covid symptoms) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, TAMSULOSIN, IBRUTINIB (IMBRUVICA), ATORVASTATIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), GLIPIZIDE, ZINC and ASCORBIC ACID (VITAMIN C ACID).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 24-Feb-2021, the patient experienced HYPERHIDROSIS (terrible sweating to the point where I almost wet a bed), PYREXIA (fever of 101 F) and INFLUENZA LIKE ILLNESS (He felt like he had a Covid symptoms). On 25-Feb-2021, HYPERHIDROSIS (terrible sweating to the point where I almost wet a bed), PYREXIA (fever of 101 F) and INFLUENZA LIKE ILLNESS (He felt like he had a Covid symptoms) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.	Leukemia.	1597650-1	65-79 years	2021/08
120	MODERNA	Developed high fever; Very sick; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Developed high fever) and ILLNESS (Very sick) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia (Had leukemia for 30 years).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (Developed high fever) and ILLNESS (Very sick). At the time of the report, PYREXIA (Developed high fever) and ILLNESS (Very sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment details included use of Extra strength Tylenol and Motrin Alternating The reporter was concerned if its ok for fever to rise up to 101.8 degree F	Leukemia (Had leukemia for 30 years)	1599355-1	65-79 years	2021/08
121	MODERNA	"a lot of fatigue""; ""severe joint pain""; ""fever""; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (""a lot of fatigue""), ARTHRALGIA (""severe joint pain"") and PYREXIA (""fever"") in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included Chronic lymphocytic leukemia (exposed to Agent Orange spray during the war).   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 15-Mar-2021, the patient experienced FATIGUE (""a lot of fatigue""), ARTHRALGIA (""severe joint pain"") and PYREXIA (""fever""). On 22-Mar-2021, FATIGUE (""a lot of fatigue""), ARTHRALGIA (""severe joint pain"") and PYREXIA (""fever"") had resolved.            no concomitant medications reported. no treatment details reported.""	No current illness for this event.	1599405-1	Unknown	2021/08
122	MODERNA	Leg pain; Back Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain) and BACK PAIN (Back Pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia, Lymphoma, Pancreatic cancer and Heart valve disorders.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Leg pain) and BACK PAIN (Back Pain). At the time of the report, PAIN IN EXTREMITY (Leg pain) and BACK PAIN (Back Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included pain killers. No Concomitant medication were reported. Patient states that her Doctor warned her she would probably have pain due to her history of multiple Cancer.   This case was linked to MOD-2021-121825, MOD-2021-121825 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Additional information received on 11-MAY-2021 and does not contain any new information.	Heart valve disorders; Leukemia; Lymphoma; Pancreatic cancer	1599681-1	65-79 years	2021/08
123	MODERNA	Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Moderate use). Family history included Birt-Hogg-Dube syndrome (Family genetic disease: maternal side, including mother, grandmother), Breast cancer (From maternal side), Colon cancer (From maternal side), Leukemia (From maternal side) and Heart disease, unspecified (On paternal side). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 07-Dec-2020 and the estimated date of delivery was 13-Sep-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Pregnancy test: positive (Positive) Positive. On 25-Feb-2021, Prenatal screening test: normal (normal) Normal. On 08-Apr-2021, Alpha 1 foetoprotein amniotic fluid: normal (normal) Normal. On 28-Apr-2021, Amniocentesis: normal (normal) Normal, 20 week US.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event (Exposure during pregnancy) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up information received on 10-May-2021, patients date of birth, gestation period (22 weeks), relevant medical history [Family genetic disease: Birt-Hogge Dube, cancers (breast, colon, leukemia), heart disease],  date of positive pregnancy test, diagnostic findings (Cell Free DNA, AFP, 20 week US), Alcohol use (moderate use).	No current illness for this event.	1601260-1	30-39 years	2021/08
124	MODERNA	injection arm lump; injection arm itched like crazy; injection arm large red area with minor eruptions; injection arm swollen; injection arm rash from shoulder to elbow; extreme Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (injection arm lump), VACCINATION SITE PRURITUS (injection arm itched like crazy), INJECTION SITE RASH (injection arm large red area with minor eruptions), VACCINATION SITE SWELLING (injection arm swollen) and VACCINATION SITE ERYTHEMA (injection arm rash from shoulder to elbow) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028B21A and 0115120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leukemia since an unknown date.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE MASS (injection arm lump), INJECTION SITE RASH (injection arm large red area with minor eruptions), VACCINATION SITE SWELLING (injection arm swollen), VACCINATION SITE ERYTHEMA (injection arm rash from shoulder to elbow) and FATIGUE (extreme Fatigue). 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (injection arm itched like crazy). On 28-Mar-2021, VACCINATION SITE MASS (injection arm lump), VACCINATION SITE PRURITUS (injection arm itched like crazy), INJECTION SITE RASH (injection arm large red area with minor eruptions), VACCINATION SITE SWELLING (injection arm swollen), VACCINATION SITE ERYTHEMA (injection arm rash from shoulder to elbow) and FATIGUE (extreme Fatigue) had resolved.            Concomitant medications use was not provided.  Treatment information was not reported.	Leukemia	1601613-1	80+ years	2021/08
125	MODERNA	Soreness at the Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the Injection site) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) for an unknown indication.     The patient's past medical history included Thrombocytopenic purpura (Resolved). Concurrent medical conditions included Chronic lymphocytic leukemia (partial remission).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the Injection site). On 01-Feb-2021, VACCINATION SITE PAIN (Soreness at the Injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.         Treatment information not provided.  In Mar 2021 patient also undergone T-Cell test specific to Covid-19 which came positive.   This case was linked to MOD-2021-065382 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up received on 14 May 2021, investigations reported	Chronic lymphocytic leukemia (partial remission)	1601991-1	65-79 years	2021/08
126	MODERNA	Aches; Fatigue; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches), FATIGUE (Fatigue) and PYREXIA (low grade fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included Idiopathic thrombocytopenic purpura (resolved) and Lymphocytic leukemia (Chronic Lymphocytic Leukemia which is in partial remission). Concomitant products included IMMUNOGLOBULINS NOS (IMMUNE GLOBULIN) for Chronic lymphocytic leukemia, PARACETAMOL (TYLENOL), Veoclexta and IBRUTINIB (IMBRUVICA) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Aches), FATIGUE (Fatigue) and PYREXIA (low grade fever). On 27-Feb-2021, MYALGIA (Aches), FATIGUE (Fatigue) and PYREXIA (low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.         Treatment medication use was not provided by the reporter.  The patient got Covid-19 antibody test to check if he developed any antibodies to Covid-19. The results came back negative   The patient's immunologist recommended to get a T-cell specific test to Covid-19. The test was approved by the FDA on 05 Mar 2021. The results came back positive.   This case was linked to MOD-2021-065381 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received and lab details were updated.	No current illness for this event.	1601992-1	65-79 years	2021/08
127	MODERNA	pain at injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site left arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphoid leukemia.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site left arm). The patient was treated with PREDNISONE at an unspecified dose and frequency and AZITHROMYCIN at an unspecified dose and frequency. On 25-Mar-2021, VACCINATION SITE PAIN (pain at injection site left arm) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, SARS-CoV-2 test: positive (Positive) tested positive for the COVID-19 virus..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were not provided.	Chronic lymphoid leukemia	1603794-1	50-59 years	2021/08
128	MODERNA	Antibodies test came back negative after almost a month from the second dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Antibodies test came back negative after almost a month from the second dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Antibodies test came back negative after almost a month from the second dose). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Antibodies test came back negative after almost a month from the second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: negative (Negative) Negative.         No relevant concomitant medication was reported.  Treatment information was not provided.	Leukemia	1604717-1	80+ years	2021/08
129	MODERNA	lack of smell; lack of taste; tired; chills; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lack of smell), AGEUSIA (lack of taste), ARTHRALGIA (joint pain), FATIGUE (tired) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included Leukemia. Concurrent medical conditions included Chemotherapy NOS.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced ARTHRALGIA (joint pain). On 06-Apr-2021, the patient experienced ANOSMIA (lack of smell), AGEUSIA (lack of taste), FATIGUE (tired) and CHILLS (chills). At the time of the report, ANOSMIA (lack of smell), AGEUSIA (lack of taste), ARTHRALGIA (joint pain), FATIGUE (tired) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.	Chemotherapy NOS	1604795-1	65-79 years	2021/08
130	MODERNA	Enlarge lymph nodes under left armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Enlarge lymph nodes under left armpit) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced LYMPHADENOPATHY (Enlarge lymph nodes under left armpit). At the time of the report, LYMPHADENOPATHY (Enlarge lymph nodes under left armpit) outcome was unknown. Not Provided	Chronic lymphocytic leukemia	1605887-1	Unknown	2021/08
131	MODERNA	High fever; Pains; Aches; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pains), MYALGIA (Aches), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (High fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 028LC0A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 24-Feb-2021, the patient experienced PAIN (Pains), MYALGIA (Aches), HEADACHE (Headache) and CHILLS (Chills). On an unknown date, the patient experienced PYREXIA (High fever). At the time of the report, PAIN (Pains), MYALGIA (Aches), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (High fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Negative.         Action taken with mRNA-1273 in response to the event was not applicable.  Treatment details included paracetamol for fever.	Chronic lymphocytic leukemia	1608316-1	65-79 years	2021/08
132	MODERNA	Leukemia/Ldiagnosed  Leukemia; Covid-19 Symptoms; Cramps; Diarrhea; Mouth sores,canker sore-like on the roof of her mouth and on backside of the gum behind her back tooth; Pain on right side of her head and feels like a chronic headache; Dry eye; Tinnitus was louder than normal; Vertigo; Light headed; Nauseas/ She still felt queasy; Stiffness in her neck, going up back of her head; Joint pain as an increase in the arthritis pain; This spontaneous case was reported by a patient and describes the occurrence of LEUKAEMIA (Leukemia/Ldiagnosed  Leukemia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Venous ulcer NOS. Concurrent medical conditions included Arthritis and Tinnitus.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced ARTHRITIS (Joint pain as an increase in the arthritis pain). On 09-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in her neck, going up back of her head). On 10-Apr-2021, the patient experienced VERTIGO (Vertigo), DIZZINESS (Light headed) and NAUSEA (Nauseas/ She still felt queasy). On 11-Apr-2021, the patient experienced TINNITUS (Tinnitus was louder than normal) and DRY EYE (Dry eye). On 17-Apr-2021, the patient experienced STOMATITIS (Mouth sores,canker sore-like on the roof of her mouth and on backside of the gum behind her back tooth) and HEADACHE (Pain on right side of her head and feels like a chronic headache). On 19-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and MUSCLE SPASMS (Cramps). On an unknown date, the patient experienced LEUKAEMIA (Leukemia/Ldiagnosed  Leukemia) (seriousness criteria death and medically significant) and SUSPECTED COVID-19 (Covid-19 Symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Apr-2021, VERTIGO (Vertigo), DIZZINESS (Light headed) and NAUSEA (Nauseas/ She still felt queasy) had resolved. The patient died on an unknown date. It is unknown if an autopsy was performed. At the time of death, MUSCULOSKELETAL STIFFNESS (Stiffness in her neck, going up back of her head), DIARRHOEA (Diarrhea), SUSPECTED COVID-19 (Covid-19 Symptoms), TINNITUS (Tinnitus was louder than normal), MUSCLE SPASMS (Cramps), DRY EYE (Dry eye), STOMATITIS (Mouth sores,canker sore-like on the roof of her mouth and on backside of the gum behind her back tooth), ARTHRITIS (Joint pain as an increase in the arthritis pain) and HEADACHE (Pain on right side of her head and feels like a chronic headache) outcome was unknown.            Concomitant medications were not provided. Additional treatment information also included the use of unspecified eye drops. Patient was on chemotherapy for 4 weeks.   Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of Leukemia which the Company believes is unlikely related due to the natural course of the disease.   This case was linked to US-MODERNATX, INC.-MOD-2021-080458 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant followup contains new event Leukamia with outcome fatal. On 03-Aug-2021: Follow up received included no new significant information. On 03-Aug-2021: Non Significant follow up appended included no new significant information (AE contact info updated); Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of Leukemia which the Company believes is unlikely related due to the natural course of the disease. US-MODERNATX, INC.-MOD-2021-080458:Husband case	Arthritis; Tinnitus	1608978-1	Unknown	2021/08
133	MODERNA	jitters; Fatigue; severe shortness of breath; Forgetfulness; Loss of balance; Had first panic attack in his life; Felt faint/Felt dizzy; Anxiety; Low BP; confusion; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (severe shortness of breath), MEMORY IMPAIRMENT (Forgetfulness), BALANCE DISORDER (Loss of balance), PANIC ATTACK (Had first panic attack in his life) and DIZZINESS (Felt faint/Felt dizzy) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to Bactrim), Coronary artery disease since 1988 and Chronic lymphocytic leukemia since 2010. Concomitant products included RANOLAZINE for Angina syndrome, CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, AMLODIPINE BESILATE (NORVASC) for Blood pressure, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol low, FINASTERIDE (PROSCAR) for Prostate examination.   On 14-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced DYSPNOEA (severe shortness of breath), MEMORY IMPAIRMENT (Forgetfulness), BALANCE DISORDER (Loss of balance), PANIC ATTACK (Had first panic attack in his life), DIZZINESS (Felt faint/Felt dizzy), ANXIETY (Anxiety), HYPOTENSION (Low BP), CONFUSIONAL STATE (confusion) and FATIGUE (Fatigue). On 26-Feb-2021, the patient experienced FEELING JITTERY (jitters). At the time of the report, DYSPNOEA (severe shortness of breath), MEMORY IMPAIRMENT (Forgetfulness), BALANCE DISORDER (Loss of balance), PANIC ATTACK (Had first panic attack in his life), DIZZINESS (Felt faint/Felt dizzy), ANXIETY (Anxiety) and FATIGUE (Fatigue) was resolving, HYPOTENSION (Low BP) and FEELING JITTERY (jitters) had not resolved and CONFUSIONAL STATE (confusion) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2021, COVID-19: negative (Negative) Negative. On 03-Jan-2021, Chest X-ray: negative (Negative) Negative. On 03-Jan-2021, Computerised tomogram: negative (Negative) Negative. On 03-Jan-2021, Pulmonary function test: negative (Negative) Negative. On 03-Jan-2021, Scan myocardial perfusion: negative (Negative) Negative. On 03-Jan-2021, Stress echocardiogram: negative (Negative) Negative.         On 01Mar2021 patient Saw MD. Had cardiac and lung workup. All tests within normal limits. MD states symptoms are from Moderna Vaccine. 19Apr2021 Symptoms have slowly started to go away. Action taken with mRNA-1273 in response to the events was not Applicable. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up received on 21-May-2021added patient's demographics,  Medical history was updated. Concomitant medication updated.  Lab data updated. Date of Dose 1 vaccination and batch number provided, AE outcome updated.	Chronic lymphocytic leukemia; Coronary artery disease; Drug allergy (Allergic to Bactrim)	1609133-1	65-79 years	2021/08
134	MODERNA	This spontaneous case was reported by a physician and describes the occurrence of CONTRAST MEDIA ALLERGY (Contrast media allergy), DIARRHEA (Diarrhea), DERMATITIS ALLERGIC (Allergic rash all over her body) and PERIPHERAL SWELLING (Arm swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia and Malignant neoplasm of central portion of female breast. Concurrent medical conditions included Chronic lymphocytic leukemia (Symptomatic chronic lymphocytic leukemia of B-cells reported.), Allergy to antibiotic (Allergy to sulfa-antibiotics reported.), Iodine allergy, Malignant neoplasm of central portion of female breast and Estrogen receptor positive breast cancer. Concomitant products included ANASTROZOLE (ARIMIDEX), VITAMIN D3, CYANOCOBALAMIN, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PROBIOTICS NOS and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication. On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient experienced CONTRAST MEDIA ALLERGY (Contrast media allergy), DIARRHOEA (Diarrhea), DERMATITIS ALLERGIC (Allergic rash all over her body) and PERIPHERAL SWELLING (Arm swelling). At the time of the report, CONTRAST MEDIA ALLERGY (Contrast media allergy) and DIARRHOEA (Diarrhea) outcome was unknown and DERMATITIS ALLERGIC (Allergic rash all over her body) and PERIPHERAL SWELLING (Arm swelling) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan: n/a No results reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were provided by the reporter. This case was linked to MOD-2021-086818, MOD-2021-086711, MOD-2021-086996, MOD-2021-087217, MOD-2021-087097 (E2B Linked Report).; Sender's Comments:  MOD-2021-086818:Case received in same source doc email; MOD-2021-086711:Case received in same source doc email MOD-2021-086996:Case received in same source doc email; MOD-2021-087217:Case received in same source doc email; MOD-2021-087097:Case received in same source doc email.	Allergy to antibiotic (Allergy to sulfa-antibiotics reported.); Chronic lymphocytic leukemia (Symptomatic chronic lymphocytic leukemia of B-cells reported.); Estrogen receptor positive breast cancer; Iodine allergy; Malignant neoplasm of central portion of female breast	1610256-1	65-79 years	2021/08
135	MODERNA	headache; sinus pressure; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukaemia.    The patient's past medical history included Lymphocytosis. Concurrent medical conditions included Iodine allergy, Estrogen receptor assay and Drug allergy (SULFA ANTIBIOTICS). Concomitant products included ANASTROZOLE (ARIMIDEX), COLECALCIFEROL (D3), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PROBIOTICS NOS and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient experienced PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache). At the time of the report, PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache) to have an unknown relationship.    This case was linked to MOD-2021-087097 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-086818:Case received in same source doc email MOD-2021-086711:Case received in same source doc email  MOD-2021-086996:Case received in same source doc email  MOD-2021-085006:Case received in same source doc email	No current illness for this event.	1610720-1	50-59 years	2021/08
136	MODERNA	This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (Swelling of Legs) and PRURITUS (Itching) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included DICLOFENAC EPOLAMINE, HYDROXYZINE HYDROCHLORIDE, MELATONIN and CYANOCOBALAMIN (VIT B12) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. and IBRUTINIB (IMBRUVICA) (unknown route) 420 milligram once a day. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of Legs) and PRURITUS (Itching). At the time of the report, PERIPHERAL SWELLING (Swelling of Legs) and PRURITUS (Itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment reported for these events.	Chronic lymphocytic leukemia	1610727-1	Unknown	2021/08
137	MODERNA	vaccination site erythema; vaccination site pruritus; sweating; neck pain; weght gain; appetite lost; fatigue; lymphadenopathy cervical; This spontaneous case was reported by a health care professional and describes the occurrence of   in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for CLL.    The patient's past medical history included Chronic lymphocytic leukemia in 2013, Blood pressure high, Diabetes, High cholesterol, Heartburn, Stroke and Alcohol use. Concurrent medical conditions included Drug allergy (Tetracycline,penicillin). Concomitant products included LOSARTAN and AMLODIPINE for Blood pressure high, ASPIRIN [ACETYLSALICYLIC ACID] for Cardiovascular disorder NOS, METFORMIN for Diabetes, PANTOPRAZOLE SODIUM for Heartburn, ATORVASTATIN for High cholesterol, ALLOPURINOL for Kidney disorder, TETRACYCLINE for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 mg. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.	Drug allergy (Tetracycline,penicillin)	1610742-1	65-79 years	2021/08
138	MODERNA	Abscess; Aches and pain in legs; Low grade fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABSCESS (Abscess), PAIN IN EXTREMITY (Aches and pain in legs) and PYREXIA (Low grade fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Acute myeloid leukaemia (5 YEARS REMISSION) on 15-Sep-2015, Perfume sensitivity and Allergy to plants (Hayweed). Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), VALSARTAN for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 10-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABSCESS (Abscess), PAIN IN EXTREMITY (Aches and pain in legs) and PYREXIA (Low grade fever). At the time of the report, ABSCESS (Abscess), PAIN IN EXTREMITY (Aches and pain in legs) and PYREXIA (Low grade fever) outcome was unknown.            Treatment for the event included antibiotics.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.   This case was linked to MOD-2021-033331 (Patient Link).	Allergy to plants (Hayweed); Perfume sensitivity	1610745-1	65-79 years	2021/08
139	MODERNA	Patient has worsened rising of uric acid in blood; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BLOOD URIC ACID INCREASED (Patient has worsened rising of uric acid in blood) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 006B21A) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for Chronic lymphocytic leukemia.    The patient's past medical history included Splenomegaly in 2015, Kidney failure from 2016 to 2017, Palpitation, Dehydration and Splenectomy in 2015. Concurrent medical conditions included Penicillin allergy (Penicillin allergy manifested by rash), Mitral valve prolapse, Chronic lymphocytic leukemia and Alcoholic (Four glasses of wine a week, regularly, started 1968) since 1968. Concomitant products included ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]) for Chemotherapy, METOPROLOL for Palpitation, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for an unknown indication.   On 12-May-2020, the patient started VENETOCLAX (VENCLEXTA) (Oral) 20 milligram. On 12-May-2020, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 10 milligram once a day. On 19-May-2020, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 50 milligram once a day. On 26-May-2020, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 100 milligram once a day. On 02-Jun-2020, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 200 milligram once a day. On 09-Jun-2020, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 400 milligram once a day. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD URIC ACID INCREASED (Patient has worsened rising of uric acid in blood). At the time of the report, BLOOD URIC ACID INCREASED (Patient has worsened rising of uric acid in blood) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood uric acid: (High) Comprehensive metabolic panel- Uric acid is trending up. On 17-Mar-2021, Blood uric acid: Comprehensive metabolic panel- Uric acid is trending up. On an unknown date, Blood uric acid: (High) Unknown date, uric acid rising up.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered BLOOD URIC ACID INCREASED (Patient has worsened rising of uric acid in blood) to be not related.    Concomitant medications included drug for prevention of pneumonia. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: No new information.	Alcoholic (Four glasses of wine a week, regularly, started 1968); Chronic lymphocytic leukemia; Mitral valve prolapse; Penicillin allergy (Penicillin allergy manifested by rash)	1612481-1	65-79 years	2021/08
140	MODERNA	fracture rib; skin disorder; confusion; cat scratch disease; pain in arm; peripheral swelling; This spontaneous case was reported by a physician and describes the occurrence of RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), CAT SCRATCH DISEASE (cat scratch disease) and PAIN IN EXTREMITY (pain in arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Macular degeneration (No Medical History was provided) and Arrhythmia.   On 14-May-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), CAT SCRATCH DISEASE (cat scratch disease), PAIN IN EXTREMITY (pain in arm) and PERIPHERAL SWELLING (peripheral swelling). At the time of the report, RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), PAIN IN EXTREMITY (pain in arm) and PERIPHERAL SWELLING (peripheral swelling) had not resolved and CAT SCRATCH DISEASE (cat scratch disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (pain in arm) to be possibly related. No further causality assessments were provided for RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), CAT SCRATCH DISEASE (cat scratch disease) and PERIPHERAL SWELLING (peripheral swelling).    On an unknown date, post vaccination, the patient reported that he experienced symptoms of macular degeneration, oxygen saturation low, white blood cells low and fractured rib. The patient also reported that he experienced symptoms of skin disorder, confusion, cat scratch disease and peripheral swelling.   No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: No new information was received.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except Cat Scratch disease which is unlikely.	Arrhythmia; Macular degeneration (No Medical History was provided)	1612844-1	80+ years	2021/08
141	MODERNA	injection site turned pink; hives appeared at the site of the injection; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), VACCINATION SITE URTICARIA (hives appeared at the site of the injection) and VACCINATION SITE ERYTHEMA (injection site turned pink) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included CLL (Chronic lymphocytic leukaemia).   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Itching). On 25-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (hives appeared at the site of the injection). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site turned pink). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (injection site turned pink) was resolving and VACCINATION SITE URTICARIA (hives appeared at the site of the injection) had resolved.            No relevant concomitant medications were provided. Treatment activities for event was also done with Triple antibiotic ointment. The action taken for mRNA-1273 was not applicable.	CLL (Chronic lymphocytic leukaemia)	1612982-1	65-79 years	2021/08
142	MODERNA	This spontaneous case was reported by a physician and describes the occurrence of SKIN IRRITATION (Skin irritation) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chronic lymphocytic leukemia since 16-Nov-2018. Concomitant products included IBRUTINIB (IMBRUVICA) from 16-Nov-2018 to an unknown date for Chronic lymphocytic leukemia.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN IRRITATION (Skin irritation). At the time of the report, SKIN IRRITATION (Skin irritation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.	Chronic lymphocytic leukemia	1613624-1	65-79 years	2021/08
143	MODERNA	Swollen lymph nodes; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for Lymphoma, Nodular lymphoma involving lymph nodes of axilla and upper limb and Chronic lymphocytic leukaemia.    No Medical History information was reported.   On 10-Jul-2018, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 mg once a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact	No current illness for this event.	1613684-1	60-64 years	2021/08
144	MODERNA	severe flu like symptoms, (""bad case of the flu""); swollen large area with fever in it at injection site; swollen large area with fever in it at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (severe flu like symptoms, (""bad case of the flu"")), PYREXIA (swollen large area with fever in it at injection site) and VACCINATION SITE SWELLING (swollen large area with fever in it at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A27A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukaemia.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (severe flu like symptoms, (""bad case of the flu"")), PYREXIA (swollen large area with fever in it at injection site) and VACCINATION SITE SWELLING (swollen large area with fever in it at injection site). At the time of the report, INFLUENZA LIKE ILLNESS (severe flu like symptoms, (""bad case of the flu"")), PYREXIA (swollen large area with fever in it at injection site) and VACCINATION SITE SWELLING (swollen large area with fever in it at injection site) had resolved. Not Provided          No concomitant medications were reported. No treatment medications were reported.  Patient Reports swollen large area with fever in it at injection site and also reports that this also happens when bitten by a bug due to medical diagnosis and blood disorder. Also reports severe flu like symptoms, (""bad case of the flu"").    .   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up information received on 01JUN2021, included outcome of events flu like symptoms, pyrexia and vaccination site swelling as recovered.""	Chronic lymphocytic leukaemia	1613714-1	Unknown	2021/08
145	MODERNA	a lump 1/2 the size of a golf ball in the lymph node; This spontaneous case was reported by an other caregiver and describes the occurrence of LYMPHADENOPATHY (a lump 1/2 the size of a golf ball in the lymph node) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced LYMPHADENOPATHY (a lump 1/2 the size of a golf ball in the lymph node). On 04-May-2021, LYMPHADENOPATHY (a lump 1/2 the size of a golf ball in the lymph node) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-104092 (Patient Link).	Chronic lymphocytic leukemia	1613952-1	65-79 years	2021/08
146	MODERNA	Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 030B21A) for COVID-19 vaccination.     The patient's past medical history included Bone marrow transplant (The bone marrow transplantation was done at SEP 2018.) in September 2018. Concurrent medical conditions included Acute myeloid leukemia. Concomitant products included TACROLIMUS, ALLOPURINOL and ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown. Not Provided          No treatment information was provided.  Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-106467 (Patient Link).	Acute myeloid leukemia	1614101-1	40-49 years	2021/08
147	MODERNA	shortness of breath; over 42 days since first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and PRODUCT DOSE OMISSION ISSUE (over 42 days since first vaccine) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COPD and Leukemia.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath) and PRODUCT DOSE OMISSION ISSUE (over 42 days since first vaccine). At the time of the report, DYSPNOEA (shortness of breath) and PRODUCT DOSE OMISSION ISSUE (over 42 days since first vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       After getting first shot of Moderna COVID-19 Vaccine patient experienced shortness of breathe and the pulomonologist put her on nebulizer.  Concomitant medication includes IgA transfusions, Blood Pressure medicines, Thyroid medicine, Nebulizer.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Event information is updated	No current illness for this event.	1614136-1	80+ years	2021/08
148	MODERNA	Injection site itching; Chills; Pain in knee; Nausea; Injection site redness; Vaccination site pain; Injection site swelling; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching), CHILLS (Chills), ARTHRALGIA (Pain in knee), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pulmonary oedema, Lymphadenopathy, Squamous cell carcinoma of skin, Pruritus, Photodermatosis, Weight increased, Skin irritation, Skin texture abnormal, Contusion, Epistaxis, Diarrhea and Onychoclasis. Family history included Osteoporosis (Family history of osteoporosis) since an unknown date. Concurrent medical conditions included Chronic lymphocytic leukemia and Diverticulitis. Concomitant products included IBRUTINIB (IMBRUVICA) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site itching), CHILLS (Chills), ARTHRALGIA (Pain in knee), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE ERYTHEMA (Injection site redness) was resolving and CHILLS (Chills), ARTHRALGIA (Pain in knee), NAUSEA (Nausea), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: squamous cell carcinoma (Inconclusive) Squamous cell carcinoma.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company Comment - Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.	Chronic lymphocytic leukemia; Diverticulitis; Osteoporosis (Family history of osteoporosis)	1614338-1	65-79 years	2021/08
149	MODERNA	Rheumatoid arthritis flare up; Dizziness; Increase white cell count; Swollen lymph nodes; blood pressure increased; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Chronic lymphocytic leukemia since 2018. Concomitant products included LISINOPRIL for Hypertension.   In January 2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 mg. In February 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 mg. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), DIZZINESS (Dizziness), WHITE BLOOD CELL COUNT INCREASED (Increase white cell count), BLOOD PRESSURE INCREASED and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and WHITE BLOOD CELL COUNT INCREASED (Increase white cell count) had resolved, DIZZINESS (Dizziness) and BLOOD PRESSURE INCREASED outcome was unknown and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, White blood cell count: 3000 (Inconclusive) had gone down 3000. On an unknown date, White blood cell count: 3000 (High) was up 3000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment medication were not provided   This case was linked to MOD-2021-111543, MOD-2021-111543 (Patient Link).; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.	Chronic lymphocytic leukemia	1614640-1	60-64 years	2021/08
150	MODERNA	Very sick; Extremely weak; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick), ASTHENIA (Extremely weak) and CHILLS (Chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced ILLNESS (Very sick), ASTHENIA (Extremely weak) and CHILLS (Chills). At the time of the report, ILLNESS (Very sick), ASTHENIA (Extremely weak) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Alanine aminotransferase normal (0-40): 28 (normal) 28 U/L -Normal. On 02-Apr-2021, Anion gap (5-15): 11 (normal) 11 mmol/L - Normal. On 02-Apr-2021, Anisocytosis: few (Inconclusive) Few. On 02-Apr-2021, Aspartate aminotransferase normal (0-45): 38 (normal) 38 U/L- Normal. On 02-Apr-2021, Blood albumin (3.5-5.0): 4.6 (normal) 4.6 g/dl - Normal. On 02-Apr-2021, Blood alkaline phosphatase (0-125): 151 (High) 131 U /L - High. On 02-Apr-2021, Blood bilirubin (0.0-1.3): 1.3 (normal) 1.3 mg/dl - normal.. On 02-Apr-2021, Blood calcium (8.4-10.5): 10.2 (normal) 10.2 - mg/dl - Normal. On 02-Apr-2021, Blood chloride (98-108): 103 (normal) 103 mmol/ L- Normal. On 02-Apr-2021, Blood creatinine (.5-1.2): 1.2 (normal) 1.2 mg/dl - normal. On 02-Apr-2021, Blood glucose (65-99): 107 (High) 107 mg/dl - high. On 02-Apr-2021, Blood potassium (3.5-5.0): 4.2 (normal) 4.2 mmol/L - normal. On 02-Apr-2021, Blood sodium (135-145): 141 (normal) 141 mmol/L - normal. On 02-Apr-2021, Blood urea increased (9-20): 18 (normal) 18 mg/dl - normal. On 02-Apr-2021, Carbon dioxide (23-32): 27 (normal) 27 mmol/L - normal. On 02-Apr-2021, Eosinophil count (.0-.3): 1.4 (High) high and 4 (High) 4 % - High. On 02-Apr-2021, Glomerular filtration rate: 58 (Inconclusive) 58 ml/min. On 02-Apr-2021, Haematocrit (41-52): 46.9 (normal) 46.9 % - Normal. On 02-Apr-2021, Haemoglobin (13.9-18): 14.6 (normal) 14.6 g/dl - normal. On 02-Apr-2021, Lymphocyte count: many (Inconclusive) Many, 24.49 (High) 24.49 %- high Lymphocytes skyrocket. and 70 (High) 70 % - High Lymphocytes sky rocket.. On 02-Apr-2021, Mean cell haemoglobin (27-33.3): 29 (normal) 29 pg/ml - Normal. On 02-Apr-2021, Mean cell haemoglobin concentration (31.8-37.1): 31.1 (Low) 31.1 - g/dl - low. On 02-Apr-2021, Mean cell volume (80-98): 93.1 (normal) Normal. On 02-Apr-2021, Mean platelet volume (7.4-10.5): 12.2 (High) High. On 02-Apr-2021, Monocyte count (.14-.76): 2.8 (High) High and 8 (High) 8% high. On 02-Apr-2021, Neutrophil count (1.8-7.8): 6.3 (normal) Normal, 6.3 (normal) Normal and 18 (Low) 18 % - Low. On 02-Apr-2021, Nucleated red cells (0-6): 0.0 (normal) Normal and 0.00 (normal) Normal. On 02-Apr-2021, Platelet count: decreased (Low) Decreased and 113 (Low) Low. On 02-Apr-2021, Platelet function test: few (Inconclusive) Few. On 02-Apr-2021, Poikilocytosis: few (Inconclusive) Few. On 02-Apr-2021, Polychromasia: few (Inconclusive) Few. On 02-Apr-2021, Protein total (6.0-8.2): 6.9 (normal) 6.9 g/dl- Normal. On 02-Apr-2021, Red blood cell count (4.44-6.1): 5.04 (normal) Normal. On 02-Apr-2021, Red blood cell morphology: reviewed (Inconclusive) Reviewed. On 02-Apr-2021, Red cell distribution width increased (39.0-52.2): 55.7 (High) 55.7fl - High and 16.5 (High) 16.6 % - high. On 02-Apr-2021, White blood cell count (4.6-10.8): 34.99 (High) High.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant or treatment medications provided by reporter.  Patient's WBC and lymphocytes stabilized on Wednesday 05-May-2021. other sign/symptoms are still on going .	Leukemia	1616197-1	80+ years	2021/08
151	MODERNA	drowsiness; flu like symptoms; confusion; This spontaneous case was reported by an other and describes the occurrence of SOMNOLENCE (drowsiness), INFLUENZA LIKE ILLNESS (flu like symptoms) and CONFUSIONAL STATE (confusion) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for Chronic lymphocytic leukemia.    No Medical History information was reported.   On 28-Apr-2021, the patient started VENETOCLAX (VENCLEXTA) (Oral) 50 mg. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced SOMNOLENCE (drowsiness), INFLUENZA LIKE ILLNESS (flu like symptoms) and CONFUSIONAL STATE (confusion). At the time of the report, SOMNOLENCE (drowsiness), INFLUENZA LIKE ILLNESS (flu like symptoms) and CONFUSIONAL STATE (confusion) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact	No current illness for this event.	1616234-1	60-64 years	2021/08
152	MODERNA	This spontaneous case was reported by a consumer and describes the occurrence of VITAMIN B COMPLEX DEFICIENCY (Vitamin B was deficient), DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat (same side as injection)), PELVIC PAIN (Pain in her pelvis where tumor had been) and FEELING ABNORMAL (Feels cruddy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Acute myeloid leukaemia (11 years ago) and Tumor (Tumor in  pelvis). On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat (same side as injection)), LYMPHADENOPATHY (Glands are bigger (same side as vaccination)) and NAUSEA (Queasy/Nausea). On 14-May-2021, the patient experienced PELVIC PAIN (Pain in her pelvis where tumor had been). On 18-May-2021, the patient experienced FEELING ABNORMAL (Feels cruddy). On an unknown date, the patient experienced VITAMIN B COMPLEX DEFICIENCY (Vitamin B was deficient). At the time of the report, VITAMIN B COMPLEX DEFICIENCY (Vitamin B was deficient), DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat (same side as injection)), PELVIC PAIN (Pain in her pelvis where tumor had been), LYMPHADENOPATHY (Glands are bigger (same side as vaccination)) and NAUSEA (Queasy/Nausea) outcome was unknown and FEELING ABNORMAL (Feels cruddy) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: inconclusive (Inconclusive) Vitamin B deficiency. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medications were not reported. The treatment information was not provided. This case was linked to MOD-2021-228230. Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: The follow up document was received on 20-JUN-2021.	No current illness for this event.	1616858-1	50-59 years	2021/08
153	MODERNA	Patient required hospitalization due to breakthrough infection. She received the Moderna vaccine (2nd dose in series) on 07/10/21. Hospitalized from 08/01/21 - 08/12/21 (discharged and then admitted 2 hours later, result was death in ED). Below is copied from discharge summary:   Patient is a 50 y/o morbidly obese female admitted on 8/2/2021 due to acute respiratory failure due to COVID 19 pneumonia.    Severe Sepsis with acute organ dysfunction/ Acute respiratory failure with hypoxia 2/2 COVID 19: - Now on 4L , oxygen delivered at bedside - Chest Xray showed bilateral atypical findings - CRP 63, sed rate 22.  - DVT ppx given while inpatient - dexamethasone completed x10 days on 8/10/2021 - atorvastatin given during admission - Completed Remdesevir 8/5/2021 - Isolation   Chronic lymphocytic leukemia  - Leukocytosis due to CLL  Flow cytometry with CD+5 mature B cell lymphoma  CT abdomen showing lymphadenopathy Out patient hematology follow up, no need for acute intervention    AKI: resolved  -Cr back to baseline    Hyperkalemia: -Resolved    Arterial hypertension -Controlled - continue amlodipine + HCTz   Morbid Obesity, BMI of> 40s: -would benefit from lifestyles modifications regarding low fat diet, weight loss and daily excercise -F/U with PCP     Patient is discharged in stable condition with stable vital signs. All questions rearding hospital course and plan of care after discharge have been answered to satisfaction. Prescriptions for medications needed to be taken after discharge have been given to patient. Patient has been instructed to follow up with PCP  within the next 7 days after discharge. Patient verbalizes understanding all given instructions and has no further doubts regarding discharge.   ED admission 2 hours later:  50 y.o. female presents c/o SOB. Pt was discharged from hospital today and was known covid positive. She was discharged with home O2. At home, patient's mother noticed that she was having more difficulty breathing than usual, prompting her to call 911. Pt arrived via EMS, which states she became unresponsive on arrival with a faint pulse. She quickly lost her pulse after her arrival here. Hx limited by events/condition of patient.    The history is provided by the EMS personnel, a parent and medical records. The history is limited by the condition of the patient.	No current illness for this event.	1617479-1	50-59 years	2021/08
154	MODERNA	Dry eye syndrome; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (Dry eye syndrome) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.    Co-suspect product included non-company product MINERALS NOS, VITAMINS NOS (MULTIVITAMIN AND MINERAL SUPPLEMENT) for Osteoporosis.    Family history included Sjogren's syndrome since an unknown date. Concurrent medical conditions included Leukemia. Concomitant products included MACROGOL 3350 (MIRALAX) for Digestion impaired, MAGNESIUM GLYCINATE for Leukemia, ACYCLOVIR [ACICLOVIR] for Shingles, ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient started MINERALS NOS, VITAMINS NOS (MULTIVITAMIN AND MINERAL SUPPLEMENT) (unknown route) at an unspecified dose. In February 2021, the patient experienced DRY EYE (Dry eye syndrome). The patient was treated with DEXAMETHASONE, TOBRAMYCIN (TOBRAMYCIN + DEXAMETHASONE CELSUS) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DRY EYE (Dry eye syndrome) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Mother had a history of Lupus and Raynaud's syndrome. Patient is enrolled in Covid-19 clinical trial for SARS COVE 2 Anti-Body, blood drawn twice so far. Their recent Antibody test made only 1 spike protein antibody. They want to find out if their body will still make more antibodies.   This case was linked to MOD-2021-155690 (Patient Link).	Sjogren's syndrome	1617868-1	65-79 years	2021/08
155	MODERNA	WBC count spiked to 14,000-23,000; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (WBC count spiked to 14,000-23,000) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included IBRUTINIB (IMBRUVICA) and VENETOCLAX (VENCLEXTA) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced WHITE BLOOD CELL COUNT INCREASED (WBC count spiked to 14,000-23,000). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (WBC count spiked to 14,000-23,000) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, White blood cell count: 14,000-23,000 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Since 2017, patient was taking Imbruzica 420mg 1/day. It's worked well. His new medicine is Venclexta 200mg at 8p tonight. It's being titrated up to a 400mg daily dose. he will receive IV treatment of Retuxin on his next appointment. he gets that every 28 days,its a 6 dose treatment.    treatment medication information was not provided.	Chronic lymphocytic leukemia	1619314-1	30-39 years	2021/08
156	MODERNA	Bruised; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruised) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced CONTUSION (Bruised) and VACCINATION SITE SWELLING (Vaccination site swelling). On 02-May-2021, CONTUSION (Bruised) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment include hydrocortisone cream.   This case was linked to MOD-2021-194420 (Patient Link).	Chronic lymphocytic leukemia	1621108-1	60-64 years	2021/08
157	MODERNA	A huge swollen lymph node in left armpit (2.5 inches)/Extreme Swelling under left armpit; COVID ARM; Rash that goes down and around the arm; itchy like fire; injection site red/Redness of left upper arm; shot really hurt; Small bruise at injection site; Swelling of left upper arm right below small bruise at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID ARM), RASH (Rash that goes down and around the arm), VACCINATION SITE BRUISING (Small bruise at injection site), VACCINATION SITE PRURITUS (itchy like fire) and VACCINATION SITE ERYTHEMA (injection site red/Redness of left upper arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic lymphocytic leukemia.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced VACCINATION SITE BRUISING (Small bruise at injection site). On 29-May-2021, the patient experienced VACCINATION SITE REACTION (COVID ARM). 29-May-2021, the patient experienced RASH (Rash that goes down and around the arm), VACCINATION SITE PRURITUS (itchy like fire), VACCINATION SITE ERYTHEMA (injection site red/Redness of left upper arm) and VACCINATION SITE PAIN (shot really hurt). On 06-Jun-2021, the patient experienced LYMPHADENOPATHY (A huge swollen lymph node in left armpit (2.5 inches)/Extreme Swelling under left armpit). In 2021, the patient experienced VACCINATION SITE SWELLING (Swelling of left upper arm right below small bruise at injection site). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (COVID ARM), VACCINATION SITE BRUISING (Small bruise at injection site), VACCINATION SITE PRURITUS (itchy like fire), VACCINATION SITE ERYTHEMA (injection site red/Redness of left upper arm), VACCINATION SITE PAIN (shot really hurt) and VACCINATION SITE SWELLING (Swelling of left upper arm right below small bruise at injection site) outcome was unknown and RASH (Rash that goes down and around the arm) and LYMPHADENOPATHY (A huge swollen lymph node in left armpit (2.5 inches)/Extreme Swelling under left armpit) was resolving.            No relevant concomitant medications were provided.  Approximately, on 06-Jun-2021, the patient noticed a huge swollen lymph node in left armpit. The lump was around 2.5 inches long and considerably swelled. As on 04-Jul-2021, according to the patient, the rash was mostly cleared and the lump had gone down significantly.   This case was linked to MOD-2021-194372 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Additional information received  on 5 jul 2021 contain information included additional event and outcomes of the events. On 09-Jul-2021: Additional information received on 9 jul 2021 contain information included additional event and outcomes of the events.	Chronic lymphocytic leukemia	1621114-1	60-64 years	2021/08
158	MODERNA	Injection site pain; dose administered after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (dose administered after beyond use date) and VACCINATION SITE PAIN (Injection site pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (sulfa), Allergy to homeopathic drugs (fish oil), Hyperlipidemia since 14-Nov-2017, Chronic lymphocytic leukemia since 30-Apr-2018, Type 2 diabetes mellitus since 08-Feb-2017, Chronic candidiasis since 25-Jan-2017, GERD, Arrhythmia, Heart failure and Candidiasis. Concomitant products included AMIODARONE from 28-May-2021 to an unknown date for Arrhythmia, FLUCONAZOLE from 25-May-2021 to an unknown date for Candidiasis, PANTOPRAZOLE from 31-Mar-2021 to an unknown date and SUCRALFATE from 22-Mar-2021 to an unknown date for GERD, METOPROLOL SUCCINATE from 28-May-2021 to an unknown date for Heart failure.   On 26-May-2021 at 11:52 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced OFF LABEL USE (dose administered after beyond use date). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site pain). On 26-May-2021, OFF LABEL USE (dose administered after beyond use date) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: No new information received. On 06-Jul-2021: Updated information included dose 1 time and dose 2 details, patient's race, ethnic group, medical history and concomitant medications.	Allergy to antibiotic (sulfa); Allergy to homeopathic drugs (fish oil); Arrhythmia; Candidiasis; Chronic candidiasis; Chronic lymphocytic leukemia; GERD; Heart failure; Hyperlipidemia; Type 2 diabetes mellitus.	1621135-1	65-79 years	2021/08
159	MODERNA	Told her no more treatment for Leukemia; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Told her no more treatment for Leukemia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Told her no more treatment for Leukemia). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Told her no more treatment for Leukemia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details were provided.	No current illness for this event.	1621440-1	Unknown	2021/08
160	MODERNA	Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 042B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Acute myeloid leukemia (started clinical trial drug in February 2021) since 2013. Concomitant products included AMLODIPINE from 2013 to an unknown date for Blood pressure management, VALACYCLOVIR [VALACICLOVIR] from 2013 to an unknown date and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) from 2013 to an unknown date for Cancer, FLUCONAZOLE from 2013 to an unknown date for Pneumonia fungal.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 03-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products used included Belumosudil 200mg bid as clinical trial drug since ??-Feb-2021,No treatment medication was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The patient received both doses in deltoid. Capped vaccine was kept refrigerated according to storage guidelines of between 36-46 degrees F and was only uncapped and removed from refrigeration prior to vaccination.   This case was linked to MOD-2021-215651 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Added patient demographics, added medical history and concomitant medications, Added first dose details, updated event description, added event stop date and outcome.	Acute myeloid leukemia (started clinical trial drug in February 2021)	1622113-1	60-64 years	2021/08
161	MODERNA	little red bumps, itches; rash is warm to the touch; big hump would go away but the redness stayed; rash more sensitive to heat; rash like little bubbles; rash all over body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (little red bumps, itches), SKIN WARM (rash is warm to the touch), ERYTHEMA (big hump would go away but the redness stayed), URTICARIA THERMAL (rash more sensitive to heat) and RASH VESICULAR (rash like little bubbles) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leukemia (In remission). Concurrent medical conditions included Diabetes and Single functional kidney.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced URTICARIA (little red bumps, itches), SKIN WARM (rash is warm to the touch), ERYTHEMA (big hump would go away but the redness stayed), URTICARIA THERMAL (rash more sensitive to heat), RASH VESICULAR (rash like little bubbles) and RASH (rash all over body). The patient was treated with PREDNISONE ongoing since an unknown date for Itch, at an unspecified dose and frequency and HYDROXYZINE ongoing since an unknown date for Itch, at an unspecified dose and frequency. At the time of the report, URTICARIA (little red bumps, itches), SKIN WARM (rash is warm to the touch), ERYTHEMA (big hump would go away but the redness stayed), URTICARIA THERMAL (rash more sensitive to heat), RASH VESICULAR (rash like little bubbles) and RASH (rash all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  This patient first thought the rash was bug bites. They had them on their arm, down back and down legs. They were intense and the whelps got really big. This patient received her second vaccination on 11-May-2021 (lot #036C21A).  Treatment included 2 doses of steroids, prednisone and hydroxyzine. Initial doctor told her to use bug spray. The patient thought rash was chiggers and put nail polish on rash.  It was reported that it appeared to be clearing up, but was not completely gone.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up report received.  Event details and treatment updated.	Diabetes; Single functional kidney	1622687-1	50-59 years	2021/08
162	MODERNA	Vaccine given 11 days after 30 day refrigeration expriation date of capped refrigerated vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 11 days after 30 day refrigeration expriation date of capped refrigerated vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Acute myeloid leukaemia (started clinical trial drug in February 2021) since 2013, Pneumonia fungal and Blood pressure abnormal. Concomitant products included AMLODIPINE for Blood pressure, VALACYCLOVIR [VALACICLOVIR] and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Cancer, FLUCONAZOLE for Pneumonia fungal.    On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 11 days after 30 day refrigeration expriation date of capped refrigerated vaccine). On 03-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 11 days after 30 day refrigeration expriation date of capped refrigerated vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications taken were clinical trial drug Belumosudial 200 mg BID PO.  No Treatment medications were reported.     This case was linked to MOD-2021-209266, MOD-2021-209266 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up received on 10-Jun-2021,It contains no new information.	Acute myeloid leukaemia (started clinical trial drug in February 2021); Blood pressure abnormal; Pneumonia fungal	1626968-1	60-64 years	2021/08
163	MODERNA	Sores on bottom of feet after wearing shoes with hard soles; Forearm muscles felt extremely tired; This spontaneous case was reported by an other and describes the occurrence of SKIN ULCER (Sores on bottom of feet after wearing shoes with hard soles) and MUSCLE FATIGUE (Forearm muscles felt extremely tired) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukaemia and Lymphocytic lymphoma.    The patient's past medical history included Plantar fasciitis. Concurrent medical conditions included Chronic lymphocytic leukaemia, Lymphocytic lymphoma, Joint pain since June 2020, Myalgia since July 2020, Bone pain since July 2020, Diarrhea since July 2020, Welts since 2020, Sleep disorder and Muscle pain. Concomitant products included TRAMADOL for Muscle pain, TRAZODONE for Sleep disorder.   In May 2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) 280 mg once a day. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN ULCER (Sores on bottom of feet after wearing shoes with hard soles) and MUSCLE FATIGUE (Forearm muscles felt extremely tired). At the time of the report, SKIN ULCER (Sores on bottom of feet after wearing shoes with hard soles) had not resolved and MUSCLE FATIGUE (Forearm muscles felt extremely tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, SARS-CoV-2 antibody test: negative (Negative) Negative for antibodies.         Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions could be potentially confounders for the events. Concomitant medication could be potentially co-suspects for the events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions could be potentially confounders for the events. Concomitant medication could be potentially co-suspects for the events.	Bone pain; Diarrhea; Joint pain; Lymphocytic lymphoma; Muscle pain; Myalgia; Sleep disorder; Welts	1627198-1	65-79 years	2021/08
164	MODERNA	PATIENT DESCRIBES:  1 MONTH FOLLOWING 2ND DOSE MODERNA- PLATELET COUNT 625 AFTER A BASELINE OF 236 IN 11/2020.  FOLLOWUP PLATELET COUNTS- 6/30/2021- 1684:   7/9/2021- 1566:  SEPT/ 2021- 1900.  DENIES ALL SYMPTOMS EXCEPT UNUSUAL TIREDNESS. EVALUATED BY HEMATOLOGIST-  DR.  AND DX GIVEN:  CHRONIC MYELOCYTIC LEUKEMIA.	NO ACUTE ILLNESSES	1632483-1	80+ years	2021/08
165	MODERNA	Rheumatoid arthritis flare up; Swollen lymph nodes, the lymph nodes in his right armpit swelled up; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No reported medical history.  Concurrent medical conditions included Chronic lymphocytic leukemia in 2018. Concomitant products included LISINOPRIL for Blood pressure abnormal.   In January 2021, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes, the lymph nodes in his right armpit swelled up). On 17-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). On 18-Mar-2021, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes, the lymph nodes in his right armpit swelled up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood count: 3000 (High) White count was up 3000 and 3000 (Inconclusive) White count had gone down 3000 after few weeks..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.    This case was linked to MOD-2021-113371 (Patient Link).; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.	Chronic lymphocytic leukemia	1635391-1	60-64 years	2021/08
166	MODERNA	Headache; Tiredness; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache) and FATIGUE (Tiredness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia, Diabetes and Thyroid disorder. Concomitant products included INSULIN GLARGINE (LANTUS) for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tiredness). On 24-Feb-2021, HEADACHE (Headache) and FATIGUE (Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: negative (Negative) patient did not have any antibodies to the vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient got her 1st dose of the Moderna vaccine on 22Feb2021 and her 2nd dose on 27Mar2021, both in her left, non-dominant arm in the deltoid region. For both vaccinations, experienced tiredness and headache, both started the day of their vaccines and lasted for 2 days. No medications were taken for these symptoms. Patient called as she got an antibody test done and it showed that did not have any antibodies to the vaccine and wanted to inquire about this.  Treatment information was not provided   This case was linked to MOD-2021-222249 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received on 28-JUL-2021 and does not contain any new information.	Chronic lymphocytic leukemia; Diabetes; Thyroid disorder	1635818-1	65-79 years	2021/08
167	MODERNA	Tiredness; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Tiredness) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included INSULIN GLARGINE (LANTUS) for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced FATIGUE (Tiredness) and HEADACHE (Headache). On 29-Mar-2021, FATIGUE (Tiredness) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.	Chronic lymphocytic leukemia	1635823-1	65-79 years	2021/08
168	MODERNA	Patient stated she had red liquid come out with her bowel movement; Caller does not want to receive the second dose; tired blood"" or ""not enough iron in your blood; This spontaneous case was reported by a consumer and describes the occurrence of ANAL HAEMORRHAGE (Patient stated she had red liquid come out with her bowel movement), PRODUCT DOSE OMISSION ISSUE (Caller does not want to receive the second dose) and BLOOD IRON DECREASED (tired blood"" or ""not enough iron in your blood) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included Immune system disorder (Weak immune system and frail) and Rash (Rash allergy). Concurrent medical conditions included Leukemia.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAL HAEMORRHAGE (Patient stated she had red liquid come out with her bowel movement), PRODUCT DOSE OMISSION ISSUE (Caller does not want to receive the second dose) and BLOOD IRON DECREASED (tired blood"" or ""not enough iron in your blood). At the time of the report, ANAL HAEMORRHAGE (Patient stated she had red liquid come out with her bowel movement), PRODUCT DOSE OMISSION ISSUE (Caller does not want to receive the second dose) and BLOOD IRON DECREASED (tired blood"" or ""not enough iron in your blood) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up received on 17-JUN-2021 contains no new information On 20-Jun-2021: Patient contact information updated and event added""	Leukemia	1639528-1	40-49 years	2021/08
169	MODERNA	It looked like bug bite, look like warts, allergic to vaccine; Welts comes and goes / welts turn into sores; Soreness in arm after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm after second dose), ALLERGY TO VACCINE (It looked like bug bite, look like warts, allergic to vaccine) and URTICARIA (Welts comes and goes / welts turn into sores) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Leukemia and Kidney absent (1 kidney). Concomitant products included BENAZEPRIL for Blood pressure high, GLICLAZIDE and INSULIN for Diabetes, GABAPENTIN for Pains in legs, ALLOPURINOL for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm after second dose). On an unknown date, the patient experienced ALLERGY TO VACCINE (It looked like bug bite, look like warts, allergic to vaccine) and URTICARIA (Welts comes and goes / welts turn into sores). On 15-May-2021, PAIN IN EXTREMITY (Soreness in arm after second dose) had resolved. At the time of the report, ALLERGY TO VACCINE (It looked like bug bite, look like warts, allergic to vaccine) and URTICARIA (Welts comes and goes / welts turn into sores) outcome was unknown.            Treatment information included steroid tablets.   This case was linked to MOD-2021-226027 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up received and added Reporter details (mail address), medical history and added additional events (It looked like bug bite, look like warts, allergic to vaccine and Welts comes and goes/ welts turn into sores) were provided.	Diabetes; Kidney absent (1 kidney); Leukemia	1639647-1	50-59 years	2021/08
170	MODERNA	Improvement of a previous condition of CLL leukemia; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Improvement of a previous condition of CLL leukemia) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia (since 2016).   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 mg. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Improvement of a previous condition of CLL leukemia). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Improvement of a previous condition of CLL leukemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: normal (normal) white cell count decreased to normal levels.         No concomitant drugs were reported. No treatment drugs are not provided by reporter.	Leukemia (since 2016)	1639802-1	60-64 years	2021/08
171	MODERNA	Blood test reveals meaningful inflammation; Difficulty in sleeping; Pain in lower back; Muscle weakness/ Weakness in my right legs; Pain in shoulder/ especially limbs; Experiencing shoulders pain especially when i rotate my arms to right/ periodic pain and discomfort in my wrist and thumbs/Pain in hips; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Blood test reveals meaningful inflammation), SLEEP DISORDER (Difficulty in sleeping), BACK PAIN (Pain in lower back), MUSCULAR WEAKNESS (Muscle weakness/ Weakness in my right legs) and MYALGIA (Pain in shoulder/ especially limbs) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032120A and 011220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriasis (psoriasis) since 1990. Concurrent medical conditions included Polycythemia vera (polycythemia vera) since 2015, Chronic lymphocytic leukemia (chronic lymphocytic leukemia) since 2015, Herpes on lip (lip herpes) since 1985, Drug allergy (Sulfa drugs), Drug allergy (diamox) and Drug allergy (amplodomine besylate). Concomitant products included LISINOPRIL from 01-Dec-2020 to an unknown date for Blood pressure high, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL-D) for Calcium, ATORVASTATIN for Cholesterol, HYDROXYUREA for Chronic lymphocytic leukemia.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INFLAMMATION (Blood test reveals meaningful inflammation), SLEEP DISORDER (Difficulty in sleeping), BACK PAIN (Pain in lower back), MUSCULAR WEAKNESS (Muscle weakness/ Weakness in my right legs), MYALGIA (Pain in shoulder/ especially limbs) and ARTHRALGIA (Experiencing shoulders pain especially when i rotate my arms to right/ periodic pain and discomfort in my wrist and thumbs/Pain in hips). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date at a dose of 3 milligram. At the time of the report, INFLAMMATION (Blood test reveals meaningful inflammation), MYALGIA (Pain in shoulder/ especially limbs) and ARTHRALGIA (Experiencing shoulders pain especially when i rotate my arms to right/ periodic pain and discomfort in my wrist and thumbs/Pain in hips) had not resolved, SLEEP DISORDER (Difficulty in sleeping) and MUSCULAR WEAKNESS (Muscle weakness/ Weakness in my right legs) outcome was unknown and BACK PAIN (Pain in lower back) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Blood test: abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took prednisone initially 10 mg per day then reduced to 5 mg per day then reduced to 4 mg per day and was currently at 3 mg per day.  Patient was no longer experiencing pain in lower back and hips. Blood tests did not show arthritis.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: significant follow up received on 15-jul-2021. Added patient demographics, relevant history lip herpes, concomitant medication, vaccine batch number and route added and  events start date added	Chronic lymphocytic leukemia (chronic lymphocytic leukemia); Drug allergy (Sulfa drugs); Drug allergy (diamox); Drug allergy (amplodomine besylate); Herpes on lip (lip herpes); Polycythemia vera (polycythemia vera); Psoriasis (psoriasis)	1640250-1	80+ years	2021/08
172	MODERNA	Admit 8/9/2021 with splenic infarct on their CT imaging. Pt has also recently had cough and was diagnosed with bronchitis by her PCP. Symptoms improved with use of CPAP at home. Her coughing spells at times have left her feeling dyspneic starting 3 days ago. Myeloproliferative leukemia on oral chemo twice daily.  SARS COV2 COVID 19 PCR positive 8/10/21.  SARS COV2 Antibody Nonreactive 8/13/2021.  8/22/2021: discharged Note: patient previously vaccinated with Moderna COVID-19 vaccine, last dose on 6/19/2021.	Myeloproliferative leukemia	1641330-1	65-79 years	2021/08
173	MODERNA	Fiscally noticed that a rash that was caused by the medicine went away; White blood cell count increased; Platelet count increased; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Fiscally noticed that a rash that was caused by the medicine went away), WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased) and PLATELET COUNT INCREASED (Platelet count increased) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic myeloid leukemia since 20-Jun-2000 and Rash. Concomitant products included IMATINIB for Leukaemia, ACETYLSALICYLIC ACID (BABY ASPIRIN), LOSARTAN, TORSEMIDE, ATORVASTATIN and ALLOPURINOL for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Fiscally noticed that a rash that was caused by the medicine went away), WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased) and PLATELET COUNT INCREASED (Platelet count increased). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Fiscally noticed that a rash that was caused by the medicine went away) had resolved and WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased) and PLATELET COUNT INCREASED (Platelet count increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Philadelphia chromosome positive: inconclusive (Inconclusive) measures bad white cells. On an unknown date, Platelet count: high (High) High. On an unknown date, White blood cell count: increased (High) Increased white cells by 20% after two weeks from second dose.         Patient had event after increasing dose of imatinib  from 300 mg to 400 mg. Increase was on 01 June. Patient had another blood test and complete BCR-ABL to check defective blood cells and result by 20 July.  Action taken with mRNA-1273 in response to the event was not applicable  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-233328 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-JUL-2021 and does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.	Chronic myeloid leukemia; Rash	1643181-1	65-79 years	2021/08
174	MODERNA	she can not move her right leg at all where she had the cancer, it is in so much pain; she can not move her right leg at all where she had the cancer; right arm injection site pain; reports that she had could not breathe and had shortness of breath; about 3-4 hours post vaccination, all of her muscles were really sore/she had a lot of muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (reports that she had could not breathe and had shortness of breath), PAIN IN EXTREMITY (she can not move her right leg at all where she had the cancer, it is in so much pain), HYPOKINESIA (she can not move her right leg at all where she had the cancer), MYALGIA (about 3-4 hours post vaccination, all of her muscles were really sore/she had a lot of muscle pain) and VACCINATION SITE PAIN (right arm injection site pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Leukemia (had blood cancer in the left arm) and Sarcoma (had sarcoma in the right leg and had chemotherapy and radiation (this cancer attacked her entire right femur and she had to get an incision from the groin all the way down to the knee)). Concomitant products included VITAMINS NOS, PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), ZOLPIDEM TARTRATE (AMBIEN) and ALPRAZOLAM (XANAX) for an unknown indication.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced DYSPNOEA (reports that she had could not breathe and had shortness of breath) and MYALGIA (about 3-4 hours post vaccination, all of her muscles were really sore/she had a lot of muscle pain). On 01-Jun-2021, the patient experienced PAIN IN EXTREMITY (she can not move her right leg at all where she had the cancer, it is in so much pain), HYPOKINESIA (she can not move her right leg at all where she had the cancer) and VACCINATION SITE PAIN (right arm injection site pain). At the time of the report, DYSPNOEA (reports that she had could not breathe and had shortness of breath), PAIN IN EXTREMITY (she can not move her right leg at all where she had the cancer, it is in so much pain), HYPOKINESIA (she can not move her right leg at all where she had the cancer), MYALGIA (about 3-4 hours post vaccination, all of her muscles were really sore/she had a lot of muscle pain) and VACCINATION SITE PAIN (right arm injection site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2021, Heart rate: 120 heart beats per minute (High) 120 bpm (as per patient high for her age).         No treatment information was provided.   This case was linked to MOD-2021-193250 (Patient Link).	Leukemia (had blood cancer in the left arm); Sarcoma (had sarcoma in the right leg and had chemotherapy and radiation (this cancer attacked her entire right femur and she had to get an incision from the groin all the way down to the knee))	1643977-1	50-59 years	2021/08
175	MODERNA	joint pains in her neck, hips, back, thighs, and waist; joint pains in her neck, hips, back, thighs, and waist; joint pains in her neck, hips, back, thighs, and waist; dry eyes; redness at the injection site; soreness at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (joint pains in her neck, hips, back, thighs, and waist), NECK PAIN (joint pains in her neck, hips, back, thighs, and waist), DRY EYE (dry eyes), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (soreness at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Sjogren's syndrome (Family history includes Sjogren's syndrome (her mother.) Concurrent medical conditions included Chronic lymphocytic leukemia (in remission) (She was being treated for her CLL in JUL2018 to NOV2018 with CD20 targeting medications .), Osteoporosis and COPD. Concomitant products included ACYCLOVIR [ACICLOVIR], RITUXIMAB and OBINUTUZUMAB (GAZYVA) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). On 21-Feb-2021, the patient experienced DRY EYE (dry eyes). On an unknown date, the patient experienced BACK PAIN (joint pains in her neck, hips, back, thighs, and waist), NECK PAIN (joint pains in her neck, hips, back, thighs, and waist) and ARTHRALGIA (joint pains in her neck, hips, back, thighs, and waist). On 10-Feb-2021, VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) had resolved. At the time of the report, BACK PAIN (joint pains in her neck, hips, back, thighs, and waist), NECK PAIN (joint pains in her neck, hips, back, thighs, and waist) and ARTHRALGIA (joint pains in her neck, hips, back, thighs, and waist) outcome was unknown and DRY EYE (dry eyes) had not resolved.            Patient  current testing reveals a 1.0 response for antibodies using a SARS-COV-2 AB test and a semiquantitative test showed 1/10 . Treatment information was provided i.e., eye drops.   This case was linked to MOD-2021-251807 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: significant follow up received on 10-AUG-2021 contains new information. Current medications added. Lab data added in I narrative .Patient historical vaccines added.Concomitant medications added.	Chronic lymphocytic leukemia (in remission) (She was being treated for her CLL in JUL2018 to NOV2018 with CD20 targeting medications .); COPD; Osteoporosis.	1644229-1	65-79 years	2021/08
176	MODERNA	she was diagnosed with AML Leukemia; Diagnosis: Poison Ivy; Two weeks ago, she broke out in red spots all over her body; did not feel well; fourth, side effect from the Moderna vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE MYELOID LEUKAEMIA (she was diagnosed with AML Leukemia), EXPOSURE TO TOXIC AGENT (Diagnosis: Poison Ivy), RASH ERYTHEMATOUS (Two weeks ago, she broke out in red spots all over her body), MALAISE (did not feel well) and ADVERSE EVENT (fourth, side effect from the Moderna vaccine.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Acute myeloid leukemia (About 10 days ago, she was diagnosed with AML Leukemia).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACUTE MYELOID LEUKAEMIA (she was diagnosed with AML Leukemia) (seriousness criteria medically significant and life threatening), EXPOSURE TO TOXIC AGENT (Diagnosis: Poison Ivy) (seriousness criterion life threatening), RASH ERYTHEMATOUS (Two weeks ago, she broke out in red spots all over her body) (seriousness criterion life threatening), MALAISE (did not feel well) (seriousness criterion life threatening) and ADVERSE EVENT (fourth, side effect from the Moderna vaccine.) (seriousness criterion life threatening). At the time of the report, ACUTE MYELOID LEUKAEMIA (she was diagnosed with AML Leukemia), EXPOSURE TO TOXIC AGENT (Diagnosis: Poison Ivy), RASH ERYTHEMATOUS (Two weeks ago, she broke out in red spots all over her body), MALAISE (did not feel well) and ADVERSE EVENT (fourth, side effect from the Moderna vaccine.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: 11000 (Low) 11000, 16000 (Low) 16000 and 8 (Low) 8. In 2021, Red blood cell count: wasn't much better (abnormal) red blood count wasn't much better. In 2021, White blood cell count: 0 (Low) Her White blood count is almost zero.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Three weeks later, after Moderna Covid vaccine administration .Patient  had a full body itchy rash. That lasted about two months. Saw four doctors,they Diagnosed as Poison Ivy, Poison Oak, Poison Sumac and fourth, side effect from the Moderna vaccine. Two weeks ago,patient broke out in red spots all over her body and did not feel well. Doctor sent her to ER for blood work. Her platelets were 11,000; next morning were 16,000 and a day or two later, platelets were 8, Her White blood count was almost zero and red blood count wasn't much better.About 10 days ago, she was diagnosed with AML Leukemia.She has lost her job because of this.Her treatments will last 6-7 months, at least.  No concomitant medications are reported . No treatment medications are reported  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Further information has been requested.	Acute myeloid leukemia (About 10 days ago, she was diagnosed with AML Leukemia)	1644513-1	40-49 years	2021/08
177	MODERNA	pain spread to her wrist; could barely move her hands; pain now moving up both arms; pain is now spreading to her neck; patient is not able to drive as a result of these conditions; Infection or inflammation; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain spread to her wrist), MOBILITY DECREASED (could barely move her hands), PAIN IN EXTREMITY (pain now moving up both arms), NECK PAIN (pain is now spreading to her neck), IMPAIRED DRIVING ABILITY (patient is not able to drive as a result of these conditions) and INFECTION (Infection or inflammation) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included PREDNISONE for Pain.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain spread to her wrist) (seriousness criterion medically significant), MOBILITY DECREASED (could barely move her hands) (seriousness criterion medically significant), PAIN IN EXTREMITY (pain now moving up both arms) (seriousness criterion medically significant), NECK PAIN (pain is now spreading to her neck) (seriousness criterion medically significant), IMPAIRED DRIVING ABILITY (patient is not able to drive as a result of these conditions) (seriousness criterion medically significant) and INFECTION (Infection or inflammation) (seriousness criterion medically significant). The patient was treated with IBUPROFEN ongoing since an unknown date for Pain, at an unspecified dose and frequency and ACETAMINOPHEN ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (pain spread to her wrist), MOBILITY DECREASED (could barely move her hands), PAIN IN EXTREMITY (pain now moving up both arms), NECK PAIN (pain is now spreading to her neck) and IMPAIRED DRIVING ABILITY (patient is not able to drive as a result of these conditions) outcome was unknown and INFECTION (Infection or inflammation) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: increased (High) increased.         The patient had appointments with accupuncture , rheumatology and a chiropractor The patient was tested for Lupus, Leukemia, Carpal Tunnel and all were ruled out.  Treatment medications include steroid injection and steroid cream for pain.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286198 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded	No current illness for this event.	1644984-1	65-79 years	2021/08
178	MODERNA	diagnosed with a blood clot in my right renal artery blocking blood flow to my right kidney; Stage 3 kidney disease; terrible pain in my lower right abdomen; flu like symptoms; diarrhea; night sweats; Fever; vomiting; chills; Red rash; my right arm from shoulder to wrist was swelling; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of RENAL ARTERY THROMBOSIS (diagnosed with a blood clot in my right renal artery blocking blood flow to my right kidney) and CHRONIC KIDNEY DISEASE (Stage 3 kidney disease) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M2DA and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation since 2005, Hypertension (Medically controlled) since 2005, Chronic lymphocytic leukaemia since 2005 and Cholesterol. Concomitant products included WARFARIN from 2005 to an unknown date and ATENOLOL from 2005 to an unknown date for Atrial fibrillation, SIMVASTATIN from 2005 to an unknown date for Cholesterol, DIGOXIN from 2005 to 11-Jun-2021 for Heart failure, LEVOTHYROXINE from 2018 to an unknown date for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), PERIPHERAL SWELLING (my right arm from shoulder to wrist was swelling) and PRURITUS (itchiness). On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (diarrhea), NIGHT SWEATS (night sweats), PYREXIA (Fever), VOMITING (vomiting) and CHILLS (chills). On 16-Feb-2021, the patient experienced RENAL ARTERY THROMBOSIS (diagnosed with a blood clot in my right renal artery blocking blood flow to my right kidney) (seriousness criteria hospitalization and medically significant), CHRONIC KIDNEY DISEASE (Stage 3 kidney disease) (seriousness criterion medically significant) and ABDOMINAL PAIN (terrible pain in my lower right abdomen). The patient was hospitalized from 16-Feb-2021 to 23-Feb-2021 due to RENAL ARTERY THROMBOSIS. The patient was treated with Surgery (Catheter-based thrombectomy) for Renal artery thrombosis. On 23-Feb-2021, RENAL ARTERY THROMBOSIS (diagnosed with a blood clot in my right renal artery blocking blood flow to my right kidney) had resolved. On 15-May-2021, CHRONIC KIDNEY DISEASE (Stage 3 kidney disease), INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (diarrhea), NIGHT SWEATS (night sweats), ABDOMINAL PAIN (terrible pain in my lower right abdomen), RASH ERYTHEMATOUS (Red rash), PERIPHERAL SWELLING (my right arm from shoulder to wrist was swelling), PRURITUS (itchiness), PYREXIA (Fever), VOMITING (vomiting) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, International normalised ratio decreased: low (Low) blood INR was 1.4 upon arrival in the emergency room. It had dropped  from 3.0.         Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is expected.   This case was linked to MOD-2021-012826 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is expected.	Atrial fibrillation; Cholesterol; Chronic lymphocytic leukaemia; Hypertension (Medically controlled).	1645146-1	65-79 years	2021/08
179	MODERNA	Multiple myeloma; Blood cancer in the bone marrow; Shortness of breath; Anemic; Being tired; Fall in her garage and landed on her butt resulting in the fracturing of 5 vertebrae/ The patient already had a previous injury so this resulted in 6 vertebrae being broken; Pericarditis.; Fall in her garage and landed on her butt resulting in the fracturing; Muscle spasms; Felt like an alien was inside her as her body healed; Hemoglobin abnormal; NT-ProBMP Protein increased; This spontaneous case was reported by an other health care professional and describes the occurrence of SPINAL FRACTURE (Fall in her garage and landed on her butt resulting in the fracturing of 5 vertebrae/ The patient already had a previous injury so this resulted in 6 vertebrae being broken), PLASMA CELL MYELOMA (Multiple myeloma), LEUKAEMIA (Blood cancer in the bone marrow) and PERICARDITIS (Pericarditis.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), MAGNESIUM, OMEPRAZOLE, ESTRADIOL, AMLODIPINE BESILATE (AMLODIPINE [AMLODIPINE BESILATE]), ASPIRIN [ACETYLSALICYLIC ACID], IBUPROFEN, TRAMADOL, TIZANIDINE HYDROCHLORIDE (TIZANIDINE [TIZANIDINE HYDROCHLORIDE]) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced HAEMOGLOBIN ABNORMAL (Hemoglobin abnormal) and N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED (NT-ProBMP Protein increased). On 29-Apr-2021, the patient experienced SPINAL FRACTURE (Fall in her garage and landed on her butt resulting in the fracturing of 5 vertebrae/ The patient already had a previous injury so this resulted in 6 vertebrae being broken) (seriousness criterion medically significant), PERICARDITIS (Pericarditis.) (seriousness criterion medically significant), FALL (Fall in her garage and landed on her butt resulting in the fracturing), MUSCLE SPASMS (Muscle spasms) and FEELING ABNORMAL (Felt like an alien was inside her as her body healed). On an unknown date, the patient experienced PLASMA CELL MYELOMA (Multiple myeloma) (seriousness criterion medically significant), LEUKAEMIA (Blood cancer in the bone marrow) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath), ANAEMIA (Anemic) and FATIGUE (Being tired). At the time of the report, SPINAL FRACTURE (Fall in her garage and landed on her butt resulting in the fracturing of 5 vertebrae/ The patient already had a previous injury so this resulted in 6 vertebrae being broken), PLASMA CELL MYELOMA (Multiple myeloma), LEUKAEMIA (Blood cancer in the bone marrow), PERICARDITIS (Pericarditis.), FALL (Fall in her garage and landed on her butt resulting in the fracturing), MUSCLE SPASMS (Muscle spasms), FEELING ABNORMAL (Felt like an alien was inside her as her body healed), DYSPNOEA (Shortness of breath), ANAEMIA (Anemic), HAEMOGLOBIN ABNORMAL (Hemoglobin abnormal), N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED (NT-ProBMP Protein increased) and FATIGUE (Being tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Haemoglobin: low (Low) low,  bottomed out. On 15-Jul-2021, Protein total: elevated (High) elevated. On 15-Jul-2021, White blood cell count: low (Low) low,  bottomed out. On 04-Aug-2021, Haematocrit: 26 (abnormal) 26. On 04-Aug-2021, Haemoglobin: 10 (Low) 10. On 04-Aug-2021, Mean cell volume: 108 (abnormal) 108. On 04-Aug-2021, White blood cell count: 2.5 (abnormal) 2.5. On an unknown date, Haemoglobin: 10.2 (abnormal) 10.2%. On an unknown date, Protein total: 10 (abnormal) 10.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported.  Other lab investigation include Hemocratic was at 26 on 04-Aug-2021 , hemoglobulin elevated on 15-July-2021 , NT PROBMP protein was extremely high.  On 12-Jan-2021, Patient received first dose of Moderna COVID-19 vaccine and on 12-Feb-2021 received second dose.  In April2021, the patient underwent a bloodwork exam and it was found that Hemoglobin was at 10.2%, total protein was at 10 and the NT PROBMP protein was extremely high.   On 29-Apr-2021, patient had a fall in garage and landed on butt resulting in the fracturing of 5 vertebrae. Patient already had a previous injury so this resulted in 6 vertebrae being broken that resulted muscle spasms and felt like an alien was inside, as patient's body healed. While the patient was in the Emergency Room being treated for the fall it was found that patient had a heart murmur and was diagnosed with pericarditis.   On 15-Jul-2021, patient underwent more blood work and it was shown that white blood cell count had bottomed out, hemoglobin bottomed out, total protein elevated and hemoglobulin elevated.   On 04-Aug-2021, the doctor performed another blood panel test and white blood cell count was 2.5, hemoglobin fell to 10, Hemocratic was at 26 and MCV was 108. The patient recently had another panel done and the blood work has remained consistent and was referred to a hematologist and oncologist. The doctor believe that patient had multiple myeloma and blood cancer in the bone marrow and was seeking out medical attention to gain a diagnosed.  Currently her side effects are being tired, shortness of breath and anemic.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded	No current illness for this event.	1645355-1	65-79 years	2021/08
180	MODERNA	Chronic Myeloid Leukemia; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC MYELOID LEUKAEMIA (Chronic Myeloid Leukemia) and PAIN IN EXTREMITY (Sore arm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included FLUOXETINE, LISINOPRIL, GLIPIZIDE, METFORMIN, AMITRIPTYLINE, PANTOPRAZOLE, ASPIRIN [ACETYLSALICYLIC ACID], PIOGLITAZONE, FAMOTIDINE, SEMAGLUTIDE (OZEMPIC) and ALLOPURINOL for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHRONIC MYELOID LEUKAEMIA (Chronic Myeloid Leukemia) (seriousness criteria hospitalization and medically significant) and PAIN IN EXTREMITY (Sore arm) (seriousness criterion hospitalization). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, CHRONIC MYELOID LEUKAEMIA (Chronic Myeloid Leukemia) outcome was unknown and PAIN IN EXTREMITY (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high (High) High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       The patients latest blood work was better.  Company comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.	No current illness for this event.	1645368-1	40-49 years	2021/08
181	MODERNA	chronic phase chronic myeloid leukemia	No current illness for this event.	1651510-1	40-49 years	2021/08
182	MODERNA	Diarrhea; Tingling in arms/Tingling in legs; Sore throat; reported history of back injury in 1998 and stated that all of this is now active; his white cell count went up by 20,000 to a total of 75,000; having an overstimulated, enhanced, magnified, and amplified response to the vaccine 14 days later after receiving the vaccine; Headache; Fatigue; Neuropathy; Has crazy exaggerated dreams; feels terrible/ brain fog; feels like he has a full blown flu infection; unable to sleep/Cannot sleep/Trouble sleeping; Restless; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy), INSOMNIA (unable to sleep/Cannot sleep/Trouble sleeping), RESTLESSNESS (Restless), ABNORMAL DREAMS (Has crazy exaggerated dreams) and FEELING ABNORMAL (feels terrible/ brain fog) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included CLL. Concomitant products included IBUPROFEN for an unknown indication.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced INSOMNIA (unable to sleep/Cannot sleep/Trouble sleeping) and RESTLESSNESS (Restless). On 11-Aug-2021, the patient experienced FEELING ABNORMAL (feels terrible/ brain fog) and INFLUENZA LIKE ILLNESS (feels like he has a full blown flu infection). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy), ABNORMAL DREAMS (Has crazy exaggerated dreams), DIARRHOEA (Diarrhea), PARAESTHESIA (Tingling in arms/Tingling in legs), OROPHARYNGEAL PAIN (Sore throat), MUSCULOSKELETAL DISCOMFORT (reported history of back injury in 1998 and stated that all of this is now active), WHITE BLOOD CELL COUNT INCREASED (his white cell count went up by 20,000 to a total of 75,000), THERAPEUTIC RESPONSE UNEXPECTED (having an overstimulated, enhanced, magnified, and amplified response to the vaccine 14 days later after receiving the vaccine), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), INSOMNIA (unable to sleep/Cannot sleep/Trouble sleeping), RESTLESSNESS (Restless), ABNORMAL DREAMS (Has crazy exaggerated dreams), FEELING ABNORMAL (feels terrible/ brain fog), INFLUENZA LIKE ILLNESS (feels like he has a full blown flu infection), DIARRHOEA (Diarrhea), PARAESTHESIA (Tingling in arms/Tingling in legs), OROPHARYNGEAL PAIN (Sore throat), MUSCULOSKELETAL DISCOMFORT (reported history of back injury in 1998 and stated that all of this is now active), WHITE BLOOD CELL COUNT INCREASED (his white cell count went up by 20,000 to a total of 75,000), THERAPEUTIC RESPONSE UNEXPECTED (having an overstimulated, enhanced, magnified, and amplified response to the vaccine 14 days later after receiving the vaccine), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the reporter reported that the patient felt similar to when he had a lymphoblastic surge when his lymphocytes went up to 105,000.  No concomitant medication was reported.  No treatment medication was reported by the reporter.  The patient has trouble sleeping as he cannot sleep, is restless, has crazy exaggerated dreams, neuropathy and diarrhea. The patient also mentioned having tingling in arms and legs and believes its neuropathy. The patient stated that he has history of cancer (""chronic ""leukotosis"" leukemia"") that is unmutated. The patient believes that his antibodies are having trouble due to his cancer. The patient stated that his symptoms of headache, sore throat and fatigue went away (lot of other stuff has subsided). The patient reported history of back injury in 1998 and stated that all of this is now active. Patient stated that upon his blood test with hematologist, his white cell count went up by 20,000 to a total of 75,000.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's medical history of chronic lymphocytic leukemia could be a confounder for the events. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Followup received contains information about  past medical history, concomitant medication , events information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's medical history of chronic lymphocytic leukemia could be a confounder for the events. Further information has been requested.""	CLL	1658093-1	65-79 years	2021/08
183	MODERNA	1 month post vaccine patient developed Chronic Lymphoid Leukemia. Pt had a normal routine exam with her previous PCP in Dec of 2020 with no issues on her routine labs. 1 month post vaccine she did develop CLL. She is following with oncology for now and they are monitoring her labs.	none	1660130-1	65-79 years	2021/08
184	MODERNA	patient received 3rd dose on 19-Aug-2021; She has been ""so sick""; a horrible metallic taste in her mouth; she ""felt like she had the flu""; red rash; very hot rash; itchiness/itching; it ""has been a nightmare.""; fever up to 103; headache; muscle pains/arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received 3rd dose on 19-Aug-2021), ILLNESS (She has been ""so sick""), DYSGEUSIA (a horrible metallic taste in her mouth), INFLUENZA LIKE ILLNESS (she ""felt like she had the flu"") and RASH ERYTHEMATOUS (red rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939893, 011L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immunocompromised (compromised immune system with leukemia). Concurrent medical conditions included Leukemia.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ILLNESS (She has been ""so sick""), DYSGEUSIA (a horrible metallic taste in her mouth), INFLUENZA LIKE ILLNESS (she ""felt like she had the flu""), RASH ERYTHEMATOUS (red rash), SKIN WARM (very hot rash), PRURITUS (itchiness/itching), NIGHTMARE (it ""has been a nightmare.""), PYREXIA (fever up to 103), HEADACHE (headache) and MYALGIA (muscle pains/arm soreness). On 19-Aug-2021, the patient experienced INCORRECT DOSE ADMINISTERED (patient received 3rd dose on 19-Aug-2021). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. In August 2021, PRURITUS (itchiness/itching) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (patient received 3rd dose on 19-Aug-2021), ILLNESS (She has been ""so sick""), DYSGEUSIA (a horrible metallic taste in her mouth), INFLUENZA LIKE ILLNESS (she ""felt like she had the flu""), RASH ERYTHEMATOUS (red rash), SKIN WARM (very hot rash), NIGHTMARE (it ""has been a nightmare.""), HEADACHE (headache) and MYALGIA (muscle pains/arm soreness) outcome was unknown and PYREXIA (fever up to 103) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: bring it down for 4 hours (Low) which would bring it down for 4 hours before raising again. In August 2021, Body temperature: up to 103 (High) up to 103.         No concomitant products was provided by the reporter. The patient had been using ice on her arm as a self-treatment method and her itching symptom went away.   This case was linked to MOD-2021-294276 (Patient Link).""	Leukemia	1673013-1	65-79 years	2021/09
185	MODERNA	Congested heart failure; Bruising; Low palettes; Felt like he was going to pass out; Fatigue; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (Congested heart failure), FATIGUE (Fatigue), ASTHENIA (Weakness), CONTUSION (Bruising), PRESYNCOPE (Felt like he was going to pass out) and PLATELET COUNT DECREASED (Low palettes) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Colon cancer.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion hospitalization), ASTHENIA (Weakness) (seriousness criterion hospitalization) and PRESYNCOPE (Felt like he was going to pass out) (seriousness criterion hospitalization). On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (Congested heart failure) (seriousness criteria hospitalization and medically significant), CONTUSION (Bruising) (seriousness criterion hospitalization) and PLATELET COUNT DECREASED (Low palettes) (seriousness criterion hospitalization). The patient was hospitalized on sometime in August 2021 due to ASTHENIA, CARDIAC FAILURE CONGESTIVE, CONTUSION, FATIGUE, PLATELET COUNT DECREASED and PRESYNCOPE. At the time of the report, CARDIAC FAILURE CONGESTIVE (Congested heart failure), FATIGUE (Fatigue), ASTHENIA (Weakness), CONTUSION (Bruising), PRESYNCOPE (Felt like he was going to pass out) and PLATELET COUNT DECREASED (Low palettes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Ejection fraction: 30% (abnormal) 30%. On an unknown date, Platelet count: low (Low) low.         Concomitant medications was not reported. Treatment history was not reported. The patient was in remission from colon cancer and he was well for over a year now. The patient was on his recovery from cancer. Since last few weeks, he was experiencing fatigue weakness and felt like he was going to pass out. He was admitted to hospital last week and discharged after 4 days. Till date he was not fully diagnosed yet. His symptoms were low platelets with bruising, ejection was at 30% (blood flow) which was told that it is a congested heart failure, very fatigued and weak. He was tested by hematologist for leukemia and results did not find anything and blood tests came back ok. They still did not have a diagnosis. His oncologist planned to consult with the heart doctor that he seen while in hospital and he had a follow up appointment with heart doctor in September 2021.  Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. However, patient's previous history of colon cancer can be a confounding factor. Further information is requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. However, patient's previos history of colon cancer can be a confounding factor. Further information is requested.	No current illness for this event.	1673104-1	50-59 years	2021/09
186	MODERNA	Started not feeling good on day of injection. This continued until I was diagnosed w Acute myeloid leukemia on  May 28th 2021	Atrial fibrillation	1674967-1	65-79 years	2021/09
187	MODERNA	Fever; Arm had a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Arm had a rash) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised (compromised immune system with leukemia). Concurrent medical conditions included Leukemia.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Arm had a rash) and PYREXIA (Fever). At the time of the report, RASH (Arm had a rash) and PYREXIA (Fever) had resolved.            No concomitant products was provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-294291 (Patient Link).	Leukemia	1677186-1	65-79 years	2021/09
188	MODERNA	Could not sleep at night because of pain; Itching in the afternoon; Swelling last night; Pain in the area of injection/if she touches it there is no pain, but only the sensation; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep at night because of pain), VACCINATION SITE PRURITUS (Itching in the afternoon), VACCINATION SITE SWELLING (Swelling last night) and VACCINATION SITE PAIN (Pain in the area of injection/if she touches it there is no pain, but only the sensation) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. N/A, N/A and N/A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia and Cataracts.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, the patient experienced INSOMNIA (Could not sleep at night because of pain), VACCINATION SITE PRURITUS (Itching in the afternoon), VACCINATION SITE SWELLING (Swelling last night) and VACCINATION SITE PAIN (Pain in the area of injection/if she touches it there is no pain, but only the sensation). On 23-Aug-2021, VACCINATION SITE PRURITUS (Itching in the afternoon), VACCINATION SITE SWELLING (Swelling last night) and VACCINATION SITE PAIN (Pain in the area of injection/if she touches it there is no pain, but only the sensation) had resolved. At the time of the report, INSOMNIA (Could not sleep at night because of pain) outcome was unknown.            Concomitant medications were not provided.  Treatment medication was not provided.	Cataracts; Chronic lymphocytic leukemia	1677222-1	80+ years	2021/09
189	MODERNA	first shot he had slight reactions; slept for a fewhours; his joints hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (first shot he had slight reactions), INSOMNIA (slept for a fewhours) and ARTHRALGIA (his joints hurt a little bit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia.   On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (first shot he had slight reactions), INSOMNIA (slept for a fewhours) and ARTHRALGIA (his joints hurt a little bit). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (first shot he had slight reactions), INSOMNIA (slept for a fewhours) and ARTHRALGIA (his joints hurt a little bit) outcome was unknown.            No concomitant medications were provided.  He did not have reactions for the second dose.   Reporter did not allow further contact	Chronic lymphocytic leukemia	1678288-1	Unknown	2021/09
190	MODERNA	52 Y male with PMHx of chronic lymphoid leukemia (in remission since 2/2021), gout, anxiety, COVID-19 positive on 8/5/2021, who presented to ED on 8/31/2021 with worsening cough, fever, and SOB. Patient has had these progressive symptoms over the last 1-2 months. Patient met sepsis criteria presenting with fever 100.7F, tachycardia HR 138, and tachypnea RR 48, lactate 2.1-- >0.8 (after IV NaCl). He was positive for COVID-19 on 8/5/2021 after ~1 month of persistent productive cough, SOB, fevers (having tested negative on 7/16/21). Patient recently completed 2 courses of levofloxacin in July and August (8/26-8/30) for presumed CAP. On exam however patient is non-toxic and breathing comfortably on RA. Patient is fully vaccinated with Moderna COVID-19 vaccine since 4/2021 and has been in remission from CLL since 2/2021. CXR 8/31 with increasing opacity primarily in the right upper lung. Extensive workup initiated to r/o infectious vs malignant sources. Workup consisted of sputum cultures, sputum gram stain, AFB smear and culture, beta-d-glucan, aspergillus antigen, legionella antigen urine, procalcinotin, coccidiodes AB serum, TB gamma interferon, albumin, CRP, D-Dimer, PT, LDH, ferritin, HIV, CMV, PJP.    CAP coverage started on 8/31 with ceftriaxone and doxycycline. Case was discussed with with ID, Pulm, and Onc. Imaging findings suggested COVID-19 process rather than opportunistic infection, so recommended CT contrast of chest/abd/pelvis. 9/1 CT showed progression with 1. Overall worsening multifocal groundglass infiltrates/pneumonia, particularly in the upper lobes compared with the previous chest CT. 2. New finding of trace bilateral pleural effusions with some relatively of modest suspected adjacent compressive atelectasis in the dependent left lung base. 3. No new developing intrathoracic or abdominal bulky adenopathy. No new localized intra-abdominal inflammatory process demonstrated. Patient has allergy to contrast but consented to CT with benadryl for relief of symptoms (had had multiple CTs done in past).  9/1 COVID-19 test returned positive, cycle threshold 30.7 and 33.1 per ID. Given still COVID-19 positive, it is possible he has not fully cleared the virus. Per Onc, less concerned for recurrent CLL. Patient continued to be non toxic on exam, breathing on room air, but had sweats and fevers overnight 9/1-9/2. Still unclear what is leading to prolonged symptoms. Differential includes viral, fungal, bacterial - less likely HSP or COP. Respiratory viral panel negative. AFB smear negative. Remaining workup pending.    # COVID-19 Pneumonia vs Community-Acquired Pneumonia - Complete abx course for possible bacterial co-infection: Vantin/Doxycycline - Repeat CXR in 3-4 weeks to document resolution, if not clear, refer to Pulm   # h/o Chronic Lymphocytic Leukemia (remission since 2/2021) # Low IgG  Reason for Hospital Admission (Admitting Diagnosis):  PNEUMONIA	CLL diagnosed on flow cytometry 09/2013, Rai stage II, Binet A, Neutral cytogenetics (FISH +12).  FISH: Positive for trisomy 12 in 44% (44/100) of cells  03/19 ARUP Lab: IGHV-borderline	1678911-1	50-59 years	2021/09
191	MODERNA	I started with the chills at about 11 that night. I shook forever trying to pile covers on. Probably about 3 or 4 hours later, I felt better. I think I had taken Tylenol and that did stop the shakes. I took my temp later and it got to 100 later. I started like I had the flu: body aches; I had almost all the symptoms - sore throat and I still have sore throat really. It sorts of got better and then it came back. I got a COVID test. I had a lot of headaches. Terrible headaches - the Tylenol reduced the fever and in between I took the Rizatriptan and the Ondansetron for nausea. I didn't eat anything but broths and liquids. By Friday, I felt a little better. I took Tylenol in the morning and at 12:00, I got my weekly bloodwork done for Leukemia - (two days after the shot - 12:00 PM on 8/27/2021). My platelets had dropped to 17 - they kept re-testing it to confirm that. I saw the doctor the next day. Last Wednesday, is when my sore throat came back. This was very similar to how I reacted after the 2nd Moderna vaccine. I also got a painful shoulder for a few days - very sore. In three days, that shoulder pain was gone. It was added pain to where I do have shoulder pain at times. I was put on mega Prednisone for the low platelets. It started with 80 mg - was give that on the 29th and then I went to 60 mg (the next day) - (by this day the platelets jumped up to 70) and then the next day went to 40 mg for a week. And then my platelets were good - (tested last Thursday - they were 229) so now I am on 20 mg for a week. I will continue to taper the Prednisone. I don't know why I have the sore throat. I don't go anywhere except for a walk very early in the morning.	Had had a little bit lower platelets. Other than that I hadn't been sick.	1679235-1	65-79 years	2021/09
192	MODERNA	Emergency dental surgery; caller received the 1st Moderna vaccine on 20Apr2021 and didn't receive 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL OPERATION (Emergency dental surgery) and PRODUCT DOSE OMISSION ISSUE (caller received the 1st Moderna vaccine on 20Apr2021 and didn't receive 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia and Immunocompromised.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (caller received the 1st Moderna vaccine on 20Apr2021 and didn't receive 2nd dose). On an unknown date, the patient experienced DENTAL OPERATION (Emergency dental surgery). The patient was treated with Surgery for Dental operation. On 20-May-2021, PRODUCT DOSE OMISSION ISSUE (caller received the 1st Moderna vaccine on 20Apr2021 and didn't receive 2nd dose) had resolved. At the time of the report, DENTAL OPERATION (Emergency dental surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment information was not provided by reporter.  company comment:Very limited information regarding this event Dental Operation has been provided at this time.  Further information has been requested. The event Product Dose Omission Issue was not accompanied by any adverse event. A causality assessment is not applicable.; Sender's Comments: Very limited information regarding this event Dental Operation has been provided at this time.  Further information has been requested. The event Product Dose Omission Issue was not accompanied by any adverse event. A causality assessment is not applicable.	Immunocompromised; Leukemia	1681674-1	Unknown	2021/09
193	MODERNA	Acute leukemia; Light headedness; Too week to walk; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE LEUKAEMIA (Acute leukemia) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high (High blood pressure). Concomitant products included ATENOLOL for Blood pressure high.   On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DIZZINESS (Light headedness), GAIT DISTURBANCE (Too week to walk) and FATIGUE (Fatigue). On 26-Aug-2021, the patient experienced ACUTE LEUKAEMIA (Acute leukemia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 26-Aug-2021 due to ACUTE LEUKAEMIA. At the time of the report, ACUTE LEUKAEMIA (Acute leukemia), DIZZINESS (Light headedness), GAIT DISTURBANCE (Too week to walk) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood test: normal (normal) normal. On 26-Aug-2021, Haemoglobin: 5.5 (Low) Decreased. On 26-Aug-2021, White blood cell count: 0.2 (Low) Decreased.         No treatment medications were reported. Patient was hospitalized with acute leukemia with 5.5 hemoglobin and 0.2 white blood count and was complaining of fatigue and light headedness for the last month. For past two weeks he has been too week to walk. Patient's last bloodwork up in February 2021 was normal.  Patient does have high blood pressure and takes Atenolol.  Patient was not sure the vaccine was related and did not know exact date of first dose and did not have lot numbers.  Company Comment: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.	No current illness for this event.	1681682-1	80+ years	2021/09
194	Moderna	Deep vein thrombosis; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for CLL.    The patient's past medical history included Blood immunoglobulin G (low levels from past 20 years). Concurrent medical conditions included Chronic lymphocytic leukemia, Depression, Drug allergy (allergic reaction to Rituxan.) and Glaucoma. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   In February 2020, the patient started IBRUTINIB (IMBRUVICA) (unknown route) 420 milligram once a day. On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 antibody test (610-1600): 347 (Negative) 347.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other history included:no alcohol use, no drug abuse, non smoker Treatment information were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's past medical history of CLL and drug IBRUTINIB can contribute to this event. further information has been requested   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's past medical history of CLL and drug IBRUTINIB can contribute to this event. further information has been requested	Chronic lymphocytic leukemia; Depression; Drug allergy (allergic reaction to Rituxan.); Glaucoma	1189625-1	65-79 years	2021/04
195	Moderna	fluid overload; fatigue; Swollen lymph nodes; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FLUID OVERLOAD (fluid overload) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukaemia.    Concurrent medical conditions included Allergic reaction to drug, Chronic lymphocytic leukemia, Blood pressure high, Swollen lymph nodes, Swelling, Fatigue, Allergy to chemicals and Fruit allergy (Cantaloupes). Concomitant products included ATENOLOL for Blood pressure high, COENZYME Q10 [UBIDECARENONE], TURMERIC [CURCUMA LONGA RHIZOME], SELENIUM, VITAMIN D3, VITAMIN B COMPLEX, CALCIUM and FISH OIL for Supplementation therapy.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On 03-Apr-2021, the patient experienced FLUID OVERLOAD (fluid overload) (seriousness criterion hospitalization). The patient was hospitalized from 03-Apr-2021 to 05-Apr-2021 due to FLUID OVERLOAD. At the time of the report, FLUID OVERLOAD (fluid overload) was resolving and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Weight: 182 pounds 182 Pounds. On an unknown date, Weight: 194 pounds 194 Pounds.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated, the patient had been taking Imbruvica for the treatment of chronic lymphocytic leukemia for almost one month, but he complained that the drug had not helped to reduce the swelling, which might be caused by swollen lymph nodes. The swelling started before he started to take Imbruvica. The patient also said that the Imbruvica had not helped with his fatigue. He emphasized that he had no side effects from Imbruvica. On 03-Apr-2021, the patient was hospitalized for fluid overload, and 4.9 liters of fluid was removed from his body. He was discharged on 05-Apr-2021 to go home with a prescription of furosemide, to be taken orally daily, for the treatment of fluid overload. When he was admitted to the hospital, he weighed 194 pounds. When he was discharged from the hospital, he weighed 182 pounds. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The chronic lymphocytic leukemia is a cofounder; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The chronic lymphocytic leukemia is a cofounder	Allergic reaction to drug; Allergy to chemicals; Blood pressure high; Chronic lymphocytic leukemia; Fatigue; Fruit allergy (Cantaloupes); Swelling; Swollen lymph nodes	1301804-1	80+ years	2021/05
196	Moderna	COVID-19, Pneumonia, Mucus discharge, Nauseous, COVID-19 recurrent; pneomonia; Mucus discharge; COVID-19 recurrent; nausea; headache; body ache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19, Pneumonia, Mucus discharge, Nauseous, COVID-19 recurrent) and PNEUMONIA (pneomonia) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukemia.    No Medical History information was reported.   On 10-Apr-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 140 mg twice a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced COVID-19 (COVID-19, Pneumonia, Mucus discharge, Nauseous, COVID-19 recurrent) (seriousness criterion hospitalization) and PNEUMONIA (pneomonia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced SECRETION DISCHARGE (Mucus discharge), COVID-19 (COVID-19 recurrent), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body ache). The patient was hospitalized from 08-Jan-2021 to 12-Jan-2021 due to COVID-19. On 13-Jan-2021, COVID-19 (COVID-19, Pneumonia, Mucus discharge, Nauseous, COVID-19 recurrent) and PNEUMONIA (pneomonia) was resolving. At the time of the report, SECRETION DISCHARGE (Mucus discharge), COVID-19 (COVID-19 recurrent), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Had CT scan 2 weeks ago, which is clean and clear.. On an unknown date, Coronavirus test: positive (Positive) Covid-19 test positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication information provided.  Patient had COVID in January, was hospitalized for 5 days, lost his sense of smell and taste, which hasn't fully recovered, but is feeling better and still had fatigue. Patient had pneumonia with shortness of breath which is dissipating. Patient had taken Moderna covid vaccines, stated reactions with first time felt like he had covid again for a couple of days, and the second one gave him headaches and body aches for a day. Patient stated  his doctor says he did build up immunity from vaccine, noted from test. The medication was held when had covid for a week or two.   No relevant treatment medication information provided.  Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273. Very limited information regarding these event (pneumonia and other events) has been provided at this time. However, it is not clear if COVID-19 and pneumonia occurred prior to 1st dose of mRNA-1273.; Sender's Comments: Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273. Very limited information regarding these event (pneumonia and other events) has been provided at this time. However, it is not clear if COVID-19 and pneumonia occurred prior to 1st dose of mRNA-1273.	No current illness for this event.	1345838-1	65-79 years	2021/05
197	Moderna	Saddle Pulmonary Embolism; DVT; This spontaneous case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Saddle Pulmonary Embolism) and DEEP VEIN THROMBOSIS (DVT) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UBLITUXIMAB for an unknown indication, UMBRALISIB for an unknown indication and VENETOCLAX for an unknown indication.    Concurrent medical conditions included Hypertension, Mantle cell lymphoma, Leukemia (relapsed or refractory CLL/SLL) and Richter's syndrome.   On 28-May-2020, the patient started UBLITUXIMAB (Intravenous) 900 milligram and UMBRALISIB (Oral) 800 milligram. On 02-Sep-2020, the patient started VENETOCLAX (Oral) 400 milligram. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criteria hospitalization and medically significant). On 24-Apr-2021, the patient experienced PULMONARY EMBOLISM (Saddle Pulmonary Embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 23-Apr-2021 to 26-Apr-2021 due to DEEP VEIN THROMBOSIS and PULMONARY EMBOLISM. The patient was treated with HEPARIN on 23-Apr-2021 for DVT, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Saddle Pulmonary Embolism) and DEEP VEIN THROMBOSIS (DVT) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Ultrasound scan: dvt (abnormal) Ultrasound of lower right extremity showed acute deep vein thrombosis, DVT.. On 24-Apr-2021, Computerised tomogram: saddle pulmonary embolism (abnormal) CT on chest with IV contrast showed a saddle pulmonary embolism ..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.	Hypertension; Leukemia (relapsed or refractory CLL/SLL); Mantle cell lymphoma	1401708-1	60-64 years	2021/06
198	Moderna	Pancreatitis; Flank Pain; Allergic reaction; Abdominal Pain; Pain; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of PANCREATITIS (Pancreatitis) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukemia and SEMAGLUTIDE (OZEMPIC) for an unknown indication.    Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), EMPAGLIFLOZIN (JARDIANCE) and METOPROLOL for an unknown indication.   On 20-Dec-2017, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 140 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, IBRUTINIB (IMBRUVICA) (Oral) 280 milligram once a day and SEMAGLUTIDE (OZEMPIC) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS (Pancreatitis) (seriousness criterion medically significant), FLANK PAIN (Flank Pain), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash). At the time of the report, PANCREATITIS (Pancreatitis), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash) outcome was unknown and FLANK PAIN (Flank Pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.	Chronic lymphocytic leukemia	1435903-1	60-64 years	2021/06
199	Moderna	Heart racing; tooth extraction; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing) and TOOTH EXTRACTION (tooth extraction) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia, Heart rate abnormal (reported on 06-Nov-2019 that heart rate was in the 40s on an unknown date), Dizziness (reported on 06-Nov-2019 that he was experiencing some dizziness on an unknown date), Heart rate increased (reported by the patient on 24-Jun-2020; again reported on 30-Jun-2020 that he had been having episodes of the fast heart rate around every 3-4 weeks where it gets up to around 128 to 135 and lasts for about 3-4 minutes; again reported periodic heart rate increased by patient on 14-Jan-2021), Fatigue (reported by the patient on 24-Jun-2020), White blood cell count decreased (reported by the patient on 24-Jun-2020), Glare (reported on 30-Jun-2020) and Difficulty focusing eyes (reported on 30-Jun-2020). Concomitant products included METOPROLOL SUCCINATE, LEVOTHYROXINE SODIUM and ATORVASTATIN CALCIUM for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) 420 mg once a day. On an unknown date, the patient experienced PALPITATIONS (Heart racing) and TOOTH EXTRACTION (tooth extraction). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date for Heart racing and Tooth extraction, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart racing) and TOOTH EXTRACTION (tooth extraction) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that his heart rate was in the 130s and normally he runs in the 50-60s. He thought his heart racing was due to having large meals.   Reporter did not allow further contact	Chronic lymphocytic leukemia	1563428-1	80+ years	2021/08
200	Moderna	vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (vaccination adverse reaction) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukemia.    No Medical History information was reported.   On 28-Feb-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 140 milligram three times a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up information  received on 24-May-2021 contains non significant information. Possible NNI. On 28-May-2021: No new information provided.	No current illness for this event.	1565923-1	50-59 years	2021/08
201	Moderna	headache; sinus pressure; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukaemia.    The patient's past medical history included Lymphocytosis. Concurrent medical conditions included Iodine allergy, Estrogen receptor assay and Drug allergy (SULFA ANTIBIOTICS). Concomitant products included ANASTROZOLE (ARIMIDEX), COLECALCIFEROL (D3), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PROBIOTICS NOS and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient experienced PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache). At the time of the report, PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache) to have an unknown relationship.    This case was linked to MOD-2021-087097 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-086818:Case received in same source doc email MOD-2021-086711:Case received in same source doc email  MOD-2021-086996:Case received in same source doc email  MOD-2021-085006:Case received in same source doc email	No current illness for this event.	1610720-1	50-59 years	2021/08
202	Moderna	vaccination site erythema; vaccination site pruritus; sweating; neck pain; weght gain; appetite lost; fatigue; lymphadenopathy cervical; This spontaneous case was reported by a health care professional and describes the occurrence of   in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for CLL.    The patient's past medical history included Chronic lymphocytic leukemia in 2013, Blood pressure high, Diabetes, High cholesterol, Heartburn, Stroke and Alcohol use. Concurrent medical conditions included Drug allergy (Tetracycline,penicillin). Concomitant products included LOSARTAN and AMLODIPINE for Blood pressure high, ASPIRIN [ACETYLSALICYLIC ACID] for Cardiovascular disorder NOS, METFORMIN for Diabetes, PANTOPRAZOLE SODIUM for Heartburn, ATORVASTATIN for High cholesterol, ALLOPURINOL for Kidney disorder, TETRACYCLINE for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 mg. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.	Drug allergy (Tetracycline,penicillin)	1610742-1	65-79 years	2021/08
203	Moderna	fracture rib; skin disorder; confusion; cat scratch disease; pain in arm; peripheral swelling; This spontaneous case was reported by a physician and describes the occurrence of RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), CAT SCRATCH DISEASE (cat scratch disease) and PAIN IN EXTREMITY (pain in arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Macular degeneration (No Medical History was provided) and Arrhythmia.   On 14-May-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), CAT SCRATCH DISEASE (cat scratch disease), PAIN IN EXTREMITY (pain in arm) and PERIPHERAL SWELLING (peripheral swelling). At the time of the report, RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), PAIN IN EXTREMITY (pain in arm) and PERIPHERAL SWELLING (peripheral swelling) had not resolved and CAT SCRATCH DISEASE (cat scratch disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (pain in arm) to be possibly related. No further causality assessments were provided for RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), CAT SCRATCH DISEASE (cat scratch disease) and PERIPHERAL SWELLING (peripheral swelling).    On an unknown date, post vaccination, the patient reported that he experienced symptoms of macular degeneration, oxygen saturation low, white blood cells low and fractured rib. The patient also reported that he experienced symptoms of skin disorder, confusion, cat scratch disease and peripheral swelling.   No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: No new information was received.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except Cat Scratch disease which is unlikely.	Arrhythmia; Macular degeneration (No Medical History was provided)	1612844-1	80+ years	2021/08
204	Moderna	drowsiness; flu like symptoms; confusion; This spontaneous case was reported by an other and describes the occurrence of SOMNOLENCE (drowsiness), INFLUENZA LIKE ILLNESS (flu like symptoms) and CONFUSIONAL STATE (confusion) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for Chronic lymphocytic leukemia.    No Medical History information was reported.   On 28-Apr-2021, the patient started VENETOCLAX (VENCLEXTA) (Oral) 50 mg. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced SOMNOLENCE (drowsiness), INFLUENZA LIKE ILLNESS (flu like symptoms) and CONFUSIONAL STATE (confusion). At the time of the report, SOMNOLENCE (drowsiness), INFLUENZA LIKE ILLNESS (flu like symptoms) and CONFUSIONAL STATE (confusion) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact	No current illness for this event.	1616234-1	60-64 years	2021/08
205	Moderna	Sores on bottom of feet after wearing shoes with hard soles; Forearm muscles felt extremely tired; This spontaneous case was reported by an other and describes the occurrence of SKIN ULCER (Sores on bottom of feet after wearing shoes with hard soles) and MUSCLE FATIGUE (Forearm muscles felt extremely tired) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukaemia and Lymphocytic lymphoma.    The patient's past medical history included Plantar fasciitis. Concurrent medical conditions included Chronic lymphocytic leukaemia, Lymphocytic lymphoma, Joint pain since June 2020, Myalgia since July 2020, Bone pain since July 2020, Diarrhea since July 2020, Welts since 2020, Sleep disorder and Muscle pain. Concomitant products included TRAMADOL for Muscle pain, TRAZODONE for Sleep disorder.   In May 2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) 280 mg once a day. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN ULCER (Sores on bottom of feet after wearing shoes with hard soles) and MUSCLE FATIGUE (Forearm muscles felt extremely tired). At the time of the report, SKIN ULCER (Sores on bottom of feet after wearing shoes with hard soles) had not resolved and MUSCLE FATIGUE (Forearm muscles felt extremely tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, SARS-CoV-2 antibody test: negative (Negative) Negative for antibodies.         Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions could be potentially confounders for the events. Concomitant medication could be potentially co-suspects for the events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions could be potentially confounders for the events. Concomitant medication could be potentially co-suspects for the events.	Bone pain; Diarrhea; Joint pain; Lymphocytic lymphoma; Muscle pain; Myalgia; Sleep disorder; Welts	1627198-1	65-79 years	2021/08
206	PFIZER\BIONTECH	Patient received her covid vaccine on 12/28/2020 in her left arm. Three days after vaccination she had pain and swelling in her right arm. She was seen by a health care provider on 12/31/2020 and an ultrasound showed extensive deep venous thrombosis in the left arm. She was started on a blood thinner (eliquis).  She had blood tests done on 1/1/20 and this showed leukocytosis. She was found to have acute myeloid leukemia and admitted to our service for treatment. We do not have blood tests prior to 1/1/20 so it is unclear when her leukemia started. Her deep venous thrombosis could be related to her acute leukemia but I decided to report it due to the proximity to the time of her vaccine. Her arm pain and swelling improved after administration of the blood thinner. She is currently being treated for her leukemia.	none	0934028-1	30-39 years	2021/01
207	PFIZER\BIONTECH	Headache; Unexplainable crying/emotional; Unexplainable crying/emotional; Awful R shoulder pain; This is a spontaneous report from a contactable other HCP (patient). A 28-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231), via an unspecified route of administration on 05Jan2021 at 12:45 at single dose in right arm for covid-19 immunization. Medical history included acute lymphoblastic leukemia at age 11, remission for 14 years. The patient's concomitant medications were not reported. The patient previously took sulfamethoxazole trimethoprim (BACTRIM) and experienced allergies. The patient experienced headache, unexplainable crying/emotional, awful right shoulder pain; all on 05Jan2021 at 15:30. All events were reported as non-serious. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021.	No current illness for this event.	0939432-1	18-29 years	2021/01
208	PFIZER\BIONTECH	Resident received 1st dose on 1/4/2021. On 1/6/2021 resident having SOB, increased weakness with O2 sats at 91% RA. On 8th resident sustained a fall, O2 sats 88-92, dizzy, weakness.  Rapid COVID test performed with negative results.  Evening of 8th resident was lethargic and diaphoretic with fever of 99.9.  Resident transferred to ER, on 5lt of oxygen.  Resident returned from the ER on 1/9/2021 with new diagnosis of Leukemia and orders for hospice.  Continued with fever, crackles and N/V and loss of appetite from the 9th and 10th of January.  Resident expired at 820am on 1/11/2021.	No current illness for this event.	0942290-1	80+ years	2021/01
209	PFIZER\BIONTECH	he had an antibody titer drawn that was negative- no antibodies; This is a spontaneous report from a contactable physician (reporting for himself).  A male patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, bacth/lot no. and expiry date unknown), via an unspecified route of administration on 05Jan2021 (2nd dose) at single dose for COVID-19 immunization. Patient medical history included chronic myelocytic leukemia and was taking dasatinib (SPRYCEL)  and Jak (?). He was taking 30 mg of Jak and 100 mg of dasatinib. Patient first received his first dose of PFIZER vaccine on 16Dec2020. On 05Jan2021, patient received 2nd dose of vaccine. He had an antibody titer drawn that was negative- no antibodies on 05Jan2021. He understands per literature that patients on immunosuppressant therapy can have a diminished response to vaccine. He understands that in the clinical trials, some patients received a higher dose of the vaccine. He wanted to talk to someone about this. Wondering if he should check his antibodies titre in another week or should he get another dose of the vaccine or higher dose of it. Outcome of the event COVID-19 antibody test negative was unknown.   Information on the Lot/Batch number has been requested.	No current illness for this event.	0942622-1	Unknown	2021/01
210	PFIZER\BIONTECH	49 yo male h/o coumadin for DVT 2013 and family hx of leukemia vaccinated 01/14/2021 and noted purpuric rash and nose bleed without clos 01/18/2021 but denies bleeding gums or blood in stool or blood in urine. denies asa or nsaid usage . platelet count on cbc drawn 01/21/2021 was normal	none	0972553-1	40-49 years	2021/01
211	PFIZER\BIONTECH	Resident expired on  1/23/21 . Resident receiving care under  hospice ,diagnosis Acute Myeloid Leukemia.	Acute Myeloid Leukemia	0972782-1	80+ years	2021/01
212	PFIZER\BIONTECH	red and blotchy spots to the arm of injection site; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1283), via an unspecified route of administration on 13Jan2021 13:00 at SINGLE DOSE at arm right for COVID-19 immunization. Medical history included Chronic Lymphomatic Leukemia (CLL), and Heart attack in 2016. The patient's concomitant medications were not reported. The patient had the vaccine 4 hours ago and her whole arm down to the fingers is blotchy red as well as where the injection was given, it's her whole arm, just blotchy red dots. She received the First Dose at 1PM Eastern Time and probably about 2 and a half hours later is when the blotchiness appeared. The patient was experiencing red and blotchy spots to the arm of injection site. Redness and blotchy coloration appear to be under the skin down to her hand and wrist. She asks if this is a normal side effect. She has had no positive test for Covid Before the Vaccine. She has had No Antibody Tests. She has had No issues with vaccines in the past. The outcome of the event was not recovered.	No current illness for this event.	0973428-1	80+ years	2021/01
213	PFIZER\BIONTECH	Patient presented to waiting room after having COVID 19 vaccine #1, feeling short of breath after 5 minutes in waiting room. Color pale, skin diaphoretic. Laid patient in clinic room bed; BP 142/82 Pulse 60 (Patient avid swimmer)Pulse Oximetry 92%. O2 per nasal cannula at 2L. Patient has leukemia and received monoclonal antibodies last March. Pulse oximetry fluctuated from 92%-97% with O2 on. 911 called and report given and taken to ED per stretcher per ambulance. Patient at discharge not short of breath alert and oriented and BP 138/72-62.	No current illness for this event.	0977432-1	65-79 years	2021/01
214	PFIZER\BIONTECH	Patient presented to waiting room after having COVID 19 vaccine #1, feeling short of breath after 5 minutes in waiting room. Color pale, skin diaphoretic. Laid patient in clinic room bed; BP 142/82 Pulse 60 (Patient avid swimmer)Pulse Oximetry 92%. O2 per nasal cannula at 2L. Patient has leukemia and received monoclonal antibodies last March. Pulse oximetry fluctuated from 92%-97% with O2 on. 911 called and report given and taken to ED per stretcher per ambulance Patient at discharge not short of breath alert and oriented and BP 138/72-62.	No current illness for this event.	0977472-1	65-79 years	2021/01
215	PFIZER\BIONTECH	This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), via an unspecified route of administration in right arm, on 16Jan2021 14:45 at a single dose for covid-19 immunization. Medical history included stage 3 breast cancer, tall cell thyroid cancer, chronic lymphocytic leukemia, diabetes, and known allergies: penicillin. The patient's concomitant medications were not reported. The patient is not pregnant. The patient had no other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 17Jan2021 0800, the patient experienced minor pain at injection site and mild headache. Events were not treated. Outcome of the events was recovering.	No current illness for this event.	0986049-1	50-59 years	2021/01
216	PFIZER\BIONTECH	Sore throat/Throat was hurting; Not feeling well; Skin was sensitive; Lost his voice; Chills; Arm was hurting; Arm was hurting; This is a spontaneous report from two contactable consumers (patient and patient's wife). A male patient of an unspecified age (Age: 65; unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at single dose in arm for COVID-19 immunisation.  Medical history included he has Chronic lymphocytic leukemia (CLL), Partial transverse myelitis. The patient's concomitant medications were not reported. The patient got his first dose on 13Jan2021 and experiencing minor side effects. He was having chills, arm was hurting, sore throat, not feeling well. He said they seems to go away but then came back. Now his skin was sensitive, arm hurting again, lost his voice, throat was hurting. He asked if these events are something that could be happening from the vaccine 5 days later like this. The patient experienced Chills and Arm was hurting on 13Jan2021. The outcome was unknown.  All the events were assessed non-Serious.   Information on the lot/batch number has been requested.	No current illness for this event.	0990514-1	Unknown	2021/01
217	PFIZER\BIONTECH	she couldn't walk, clarifying that her legs were almost paralyzed feeling, and she couldn't get a walking gate on her legs; Immediate reaction ""breathy""; from the injection site of the COVID-19 Vaccine, she immediately felt heat go down her arms and legs; she said she had ""chemo shakes"", clarifying she had a kind of shivering or uncontrolled shakes; she said she had ""chemo shakes"", clarifying she had a kind of shivering or uncontrolled shakes; she had loose bowels/bowel movements were not liquid, but the bowel movements were not normal; exhausted/feels worn out; flushing in her face; her face feels hot/warm in her chest; her nose and cheeks get a sunburn heat feeling, and the heat feeling is on and off/Feels like she has a sulfur burn on her face; her skin on her arms and legs starts to feel prickly when she has the heat feeling on her nose and cheeks; bitter taste in her mouth; her blood pressure goes up/her blood pressure was like 138 or 142 over 72; having a temperature of 99, and then the temperature starts to spike; nervous; sensitivity she is having to the COVID-19 Vaccine; Enlarged lymph nodes in her neck/attacking her lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her first dose of BNT162B2 (lot number: EL3246), via an unspecified route of administration in the arm, left upper on 09Jan2021 11:45 at single dose for Covid-19 immunization. Medical history included ongoing chronic lymphocytic leukaemia (CLL) from 2008, allergic to sulfur, chemo, doesn't have a spleen because she had a bad accident 25 years ago (unspecified date in 1996). Concomitant medication included ibrutinib (IMBRUVICA) for CLL. She has been taking IMBRUVICA, but not consistently. She said she doesn't take it when she is feeling good because IMBRUVICA has side effects. The patient had intolerance to ciprofloxacin (CIPRO). There were no additional vaccines administered on same date of BNT162B2. The patient white blood cell count is 68000 and a normal white blood cell count is 10000. She said all her other blood work is very good. She said if she takes IMBRUVICA her white blood cell count goes down to 30000. She said IMBRUVICA will initially quadruple her white blood cell count before the IMBRUVICA will make her white blood cell count go down. She said she is mostly on the IMBRUVICA. She said if she tries to go off IMBRUVICA her White Blood Cell count goes up. The patient is calling about the Pfizer COVID19 Vaccine. She received the first dose of vaccine 09Jan2021, and the patient had an immediate reaction ""breathy"". She said she had a reaction right when she got the COVID-19 Vaccine, and now it is the 11th day already and she is beside herself. The patient reported that on 09Jan2021 from the injection site of the COVID-19 Vaccine, she immediately felt heat go down her arms and legs. She said she was told to go sit for a while, and that what she was experiencing would pass. She said what she experienced didn't pass. She said she got ""chemo shakes"", clarifying she had a kind of shivering or uncontrolled shakes. Reported she had to go to the bathroom 3 times while she was waiting for her side effects to improve. She clarified she had loose bowels. She said her bowels were good after the 1st week of receiving the COVID-19 Vaccine, but yesterday or 2 days ago, she had loose bowel movements. She said the bowel movements were not liquid, but the bowel movements were not normal. She had stayed at the vaccination facility site for over an hour after receiving the COVID-19 Vaccine. She said she couldn't walk, clarifying that her legs were almost paralyzed feeling, and she couldn't get a walking gate on her legs. She said after waiting for over an hour after receiving the COVID-19 Vaccine, she was exhausted and went home. Reported it took her at least 3 hours before some of her side effects started to go away. She said she is not finished with her side effects, saying it has been 11 days since she received the COVID-19 Vaccine, and she is still suffering. All events happened on 09Jan2021.She has CLL, clarifying she has Leukemia. On unspecified date in Jan2021, she found lumps (clarified as enlarged lymph nodes) under her neck 4 days after she stopped taking IMBRUVICA. She said the enlarged lymph nodes started to come back on her neck sooner than she expected. She clarified if she stops taking IMBRUVICA in preparation for a dental visit, she can be off of IMBRUVICA for 2 weeks and not have enlarged lymph nodes come back on her neck like after getting the COVID-19 Vaccine. She said the COVID-19 Vaccine is attacking her lymph nodes. She said she doesn't like mixing 2 medications (IMBRUVICA and COVID-19 Vaccine), but will have to go back on the IMBRUVICA, and hope her enlarged lymph nodes will go down. She said her cancer doctor told her not to take IMBRUVICA until she was feeling better. She clarified that IMBRUVICA is not a chemo medication. She said the last time she had chemo was when she had spiked in 2015 and had 4 chemo treatments. Also, it was reported that on 09Jan2021, she has flushing in her face, and her face feels hot, her nose and cheeks get a sunburn heat feeling, and the heat feeling is on and off, her skin on her arms and legs starts to feel prickly when she has the heat feeling on her nose and cheeks. As treatment, her cancer doctor told her to take Benadryl, she clarified she is taking Children's Benadryl, Cherry flavored. She said she has no idea how much Children's Benadryl she should be taking. She is taking Pedialyte and a (Pharmacy name) version of Pedialyte because she felt her whole system is off. She stated she has had no temperature, and her vitals were good, but yesterday on unspecified date in Jan2021, she got flushed, she gets nervous, and her blood pressure goes up. She said her blood pressure was like 138 or 142 over 72. She clarified her blood pressure was really good the first week after receiving the COVID-19 Vaccine (Jan2021). Reported her body feels like she went through something. She said her cancer doctor told her not to take the second COVID19 Vaccine dose. She said her cancer doctor recommended she get the COVID-19 Vaccine because all her blood work looked good before she got the first COVID-19 Vaccine dose. she doesn't have a spleen because she had a bad accident 25 years ago. She said maybe her not having a spleen creates the sensitivity she is having to the COVID-19 Vaccine (onset date in Jan2021). She said she doesn't get the flu vaccine. She said she looked at the papers she was given when she got the COVID-19 Vaccine and wanted to notify Pfizer and see if she could get some help as to what she should do. She said she asked her cancer doctor what she should do, and he told her he is not an expert. She said she has had every side effect listed on the COVID-19 Vaccine paperwork, but she doesn't have the blushing on her face that was listed on the paperwork. She said Pfizer should have a hotline for people to check in. She said she wants to know that she is doing the right thing, and that the COVID-19 Vaccine is not killing her. She asked if she is getting blood work in 3 weeks, will the blood work show if she has antibodies from the COVID-19 Vaccine. She was offered transfer to Pfizer Medical Information for further assistance. She forgot to mention that as soon as she got the COVID-19 Vaccine, she had a bitter taste in her mouth on 09Jan2021. She said when she starts getting hot in her cheeks, the bitter taste comes back in her mouth. Reported usually by 4:00PM she starts getting the heat in her face, but no temperature. She said she feels like she has a temperature now, clarifying it is like having a temperature of 99, and then the temperature starts to spike on unspecified date in Jan2021. She said if she did have a high temperature, she would put herself in the hospital immediately. She said she is sometimes warm in her chest, when she is having the feeling of a temperature spike. Reported she feels worn out. She said it is not like being tired where you go to sleep and wake up feeling better. She said her body is out of sync. She said it is like the body goes through shock and is trying to get back into balance. She called the specialty pharmacist to see if there was anything in the COVID-19 Vaccine that could interact with the IMBRUVICA. She said the specialty pharmacist told her there is nothing interactive with the COVID-19 Vaccine because the COVID-19 Vaccine is not a live vaccination. Reported she is allergic to sulfur. She said she feels like she has a sulfur burn on her face, if she didn't have the heat on her face too. She said the enlarged lymph nodes on her neck below her chin are very stressful. She said every side effect listed on the COVID-19 Vaccine paperwork; she has. She said the COVID-19 Vaccine paperwork mentioned lymph nodes. Therapeutic measures were taken as a result of the following events: she couldn't walk, clarifying that her legs were almost paralyzed feeling, and she couldn't get a walking gate on her legs; immediate reaction ""breathy""; from the injection site of the covid-19 vaccine, she immediately felt heat go down her arms and legs; she said she had ""chemo shakes"", clarifying she had a kind of shivering or uncontrolled shakes; she had loose bowels/bowel movements were not liquid, but the bowel movements were not normal; exhausted/feels worn out; enlarged lymph nodes in her neck/attacking her lymph nodes; flushing in her face; her face feels hot/warm in her chest; her nose and cheeks get a sunburn heat feeling, and the heat feeling is on and off/feels like she has a sulfur burn on her face; her skin on her arms and legs starts to feel prickly when she has the heat feeling on her nose and cheeks; having a temperature of 99, and then the temperature starts to spike. The outcome of the events Immediate reaction ""breathy"", nervous, sensitivity she is having to the COVID-19 Vaccine, her blood pressure goes up/her blood pressure was like 138 or 142 over 72, having a temperature of 99, and then the temperature starts to spike was unknown. The events she couldn't walk, clarifying that her legs were almost paralyzed feeling, and she couldn't get a walking gate on her legs and ""chemo shakes"", clarifying she had a kind of shivering or uncontrolled shakes recovered on 09Jan2021. The outcome of the remaining events was not recovered.""	CLL	0997236-1	Unknown	2021/02
218	PFIZER\BIONTECH	Headache; vascular rash on toes; This is a spontaneous report from a contactable consumer (patient). A 63 year-old female patient received first dose of BNT162B2 (lot number: 3246), via an unspecified route of administration on 16Jan2021 14:30 at single dose in the left arm for COVID-19 immunization. Medical history included chronic lymphocytic leukaemia from an unknown date. The patient has no known allergies. Concomitant medication included metformin extended release. On 16Jan2021, the patient experienced headache and vascular rash on toes. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any treatment for the events. The patient underwent lab tests and procedures which included PCR and nasal swab: both unknown results on 20Jan2021. The outcome of the events was not recovered.	No current illness for this event.	1000523-1	60-64 years	2021/02
219	PFIZER\BIONTECH	Stroke; leukemia; This is a spontaneous report from a contactable consumer. This consumer reported for a 68-year-old male (consumer's husband) received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EL0140, Expiry Date: Mar2021), via an unspecified route of administration on 31Dec2020 13:30 at single dose on right upper shoulder for COVID-19 prophylaxis. Medical history included smoker for 50 years, and blockage in his carotid artery. His grandma died of a stroke and his folks, his dad died of lung cancer and his mom died of uterine cancer. Both his parents had high blood pressure. His dad had a heart attack and his mom had Parkinson's because her hands would shak. There were no concomitant medications. On the 08Jan2021 at about 8PM he had a massive stroke and they had to life flight him to hospital from 08Jan2021 to 19Jan2021. He did have a blockage in his carotid artery but they have been told. She says her husband just had his second vaccine with lot is EL1283 and exp is Apr2021 and all of this could be a coincidence but he told her to call so that was why she was calling. Also he was diagnosed with, it is 4 words and then leukemia and he had an appointment with doctor to get his blood drawn every 2 weeks. The neurosurgeon that did surgery on him on 09Jan2021 at 4 am said that his carotid artery in his neck was plugged and he went in and cleaned it out and put in a stent and he said that his carotid artery was plugged all the way to his temple and he tried to get that out and couldn't. He had his stroke at 8PM on the 08Jan2021. They had dinner at 5 pm and at 6pm they were sitting on the couch and all of sudden he started slurring his words and he said his mouth felt like someone give him Novocain and then he had his arm around her and all of sudden it felt like he was choking her so she grabbed his hand and his fingers started rolling up, started closing up tight so she started playing with his fingers and then he went out in the kitchen and then he hit the floor and she called # and the paramedics came up there. When they got there he could squeeze both hands and lift both feet by that time it was 7:30, they had just brought in a chair, by time they got done bringing in the chair they realized his left side was becoming paralyzed and so they had to go back and get the stretcher so they were there for about 30 minutes, maybe 15 minutes then they headed up the hill toward the hospital at about 8pm and they came in and gave anti-blood clotting medicine and took him for a scan with dye, they found he still had a blockage on his brain so at 2AM on the 9th they came in with a medical helicopter and flew him to (institution name withheld) in (place name withheld) and they did an MRI on and seen his carotid blockage there so he had emergency surgery at from # that morning of the 09Jan2021 at (institution name withheld) and he was in ICU from Saturday until a week ago at 3 oclock 13Jan2021 he was placed in a regular room and on the 19Jan2021 at 7:30PM he was moved (hospital name) in (place name withheld) for 14 days having 15 hours per day of therapy for a week and then he will go to (place name withheld) (rehab name withheld) and he could be there 2-3 weeks. Wednesday right before they moved him he needed a therapist in the back and one in the front and a 6 inch belt to help him stand up. He started out 08Jan2021 and was put in (institution name withheld) on the 09Jan2021 and then he was discharged to rehab on the 19Jan2021 7:30 pm She has been told it may take up to year for recovery as much as he can. The week of his stroke they were adding on to his home and he was doing the electrical upstairs so it is not like he just sat around and ate bon bons, he was very active. The outcome of the events was unknown.	No current illness for this event.	1000658-1	65-79 years	2021/02
220	PFIZER\BIONTECH	Patient with past medical history of CAD, CKD, sCHF, LGL Leukemia admitted to Hospital on 1/19 with pleural effusion. Pt expired on 2/1/2021. Hs of essential HTN, complete heart block, T2Diabetes,thyroid issues, stroke, papillary CA of thyroid, dyslipidemia, anemia, hypercalcemia, pulmonary nodule, hypoparathyroidism, pacemaker, bilat carotid stenosis, afib, pleural effusion, pancytopenia, cardiomyopathy, severe aortic stenosis, sick sinus syndrome, Dressler syndrome, empyema, ESRD	see below	1000709-1	65-79 years	2021/02
221	PFIZER\BIONTECH	Chills/rigors; wheezing; shortness of breath; cough; myalgias; local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); This is a spontaneous report from a contactable physician (patient). A 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3283), via an unspecified route of administration on 20Jan2021 at a single dose on Right deltoid for COVID-19 immunization. Medical history included Chronic lymphocytic leukemia with 65% of cells lymph's, low WBC count (13500) otherwise; DM2, A1C usually close to 6.1; HTN. Unspecified concomitant medication taken. The patient previously took nickel and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9331), intramuscular on 31Dec2020 12:15 PM at a single dose on left arm for COVID-19 immunization. The patient experienced chills, rigors, wheezing, shortness of breath, local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop), cough, myalgias on 20Jan2021 23:30. Therapeutic measures were taken as a result of the events which included Benadryl, Aleve, Nebulizer treatment, change in local temperature to help stop rigors. The outcome of the events was recovering. No other vaccine in four weeks. The patient was not pregnant. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.	No current illness for this event.	1004218-1	65-79 years	2021/02
222	PFIZER\BIONTECH	Approximately 12 days after vaccination co began to have fatigue, weakness, Pancytopenia      Recent hospitalization which involved initial presentation at hospital on AK 12/29, and then again on 12/30, after eval on 12/30 was then transferred to another hospital, and later transferred where she later recovered and was discharged.      She was initially very ill and was thought to have sepsis due to fever/initial presentation/clinical picture, also had lab abnormalities including thrombocytopenia.  These things necessitated transfer.  While at hospital, hematology was consulted.  Decision was made to transfer due to concern for DIC/possibility of leukemia. Also there was concern for C Diff, treatment was given for this.  While in hospital, she underwent further testing on blood samples which revealed no evidence for malignancy, also bone marrow biopsy was performed.  While there, DIC labs were trended/began to improve.  Discharged on 1/5/21.  Had f/u with hematology @ hospital on 1/12/21.  No reason has been found as of yet as to why she became ill.  Per discharge note it's thought it could have been viral in nature, or possibly related to supplement use.  Will f/u with heme in early Feb.   Of note, she does report getting her first dose of pfizer covid vaccine on 12/17/20, she reports concern that this could have played a part in her illness.  She states this was the only new/out of the ordinary thing that she can remember recently, regarding her medical hx, prior to recent acute illness/hospitalization. Requests I reach out to inquire how she can file a report with Pfizer or CDC	none	1017232-1	30-39 years	2021/02
223	PFIZER\BIONTECH	muscle in the right arm started to hurt.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL8982) via an unspecified route of administration in right arm on 23Jan2021 09:00 at single dose for COVID-19. Medical history included rotator cuff surgery on her left arm on 28Dec2020 that was affected by a flu shot that she just got (sore left arm Flu vaccine, 26Oct2019-27Oct2019), chronic lymphocytic leukaemia (CLL) (had it 20-25 years ago stated that she watches her white blood cell count on it). Family medical history relevant to AE was none. No vaccine was received within four weeks. There were no concomitant medications. The patient experienced muscle in the right arm started to hurt on 24Jan2021 17:00. She put ice on it as treatment. Relevant tests were none. The event didn't require Emergency Room visit or Physician Office visit. The outcome of event was not recovered.	No current illness for this event.	1018663-1	65-79 years	2021/02
224	PFIZER\BIONTECH	I started with severe nosebleeds from my left nare on 1/12 with subsequent episodes on 1/14, 1/17, 1/19, and 1/21, some with headaches.  Some nosebleeds lasted nearly one hour with packing, ice to the bridge of the nose, and pressure.  I have a history of a subdural bleed in 2011 from an idiopathic spontaneous CSF leak and a daugher who passed away in 2010 from leukemia.  She had severe nosebleeds.  I also thought these nosebleeds may be related to repeated routine COVID tests twice weekly at work.  I am responsible to follow-up with vaccine recipients at my facility and one person I called asked if nosebleeds were a side effect as he knew two people who had severe nosebleeds after their vaccines.  I had not previously considerd this a possible vaccine reaction as it did not start until  over a week later. I did not have any subsequent nosebleedings after my second vaccine dose which I received on 1/24.	None	1028557-1	50-59 years	2021/02
225	PFIZER\BIONTECH	Body aches; fever - 100.8 degrees; chills; nausea; tired; This is a spontaneous report from a contactable consumer. A 53-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9263) on his left arm, via an unspecified route of administration on 25Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included chronic lymphocytic leukaemia (CLL) and covid. The patient's concomitant medications were not reported. The patient experienced Body aches, fever - 100.8 degrees, chills, nausea, tired; all on 26Jan2021 06:30 AM. No treatment was received for the events. The outcome of the events was recovered on unspecified dates.  No follow up attempts are possible. No further information is expected.	No current illness for this event.	1030046-1	50-59 years	2021/02
226	PFIZER\BIONTECH	she lost total hearing in one ear inside of five minutes/went totally deaf in her right ear; This is a spontaneous report from a contactable consumer reported for herself. A 74-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiry date: May2021), via an unspecified route of administration on left arm on 28Jan2021 16:00 at SINGLE DOSE for covid-19 immunisation. Medical history included chronic lymphocytic leukaemia, anaemia. The patient's concomitant medications were not reported. The patient previously took morphine and experienced drug hypersensitivity. The patient received the first dose of the Pfizer COVID 19 vaccine on 28Jan2021. On the 30Jan2021 04:00 PM, she lost total hearing in one ear inside of five minutes/she went totally deaf in her right ear. She has had tests done including a CT and MRI but she is still waiting for the results, which reported as under treatment. Adds she doesn't have an appointment yet, but she is supposed to get the next dose 18Feb2021. The event reported as serious with disability, result emergency room/department or urgent care. Outcome of the event was not recovered. Patient is not pregnant at the time of vaccination. No Covid prior vaccination. No covid tested post vaccination.	No current illness for this event.	1035533-1	65-79 years	2021/02
227	PFIZER\BIONTECH	Fall; fatigued; arm pain; AML; Sepsis secondary to AML; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 19Jan2021 17:30 in right arm at single dose for covid-19 immunization.  Medical history included hypertension, hyperlipidemia, OA (osteoarthritis), cognitive impairment. No other vaccine in four weeks was administrated.  Concomitant medication in two weeks included atorvastatin, aspirin, calcium, gabapentin, losartan and memantine hydrochloride (NAMENDA).  The patient previously took lisinopril and tetracycline and both experienced allergies. The patient had no covid prior vaccination. The patient initially had no symptoms but arm pain in Jan2021, no bleeding or bruising from injection. On 31Jan2021 19:00, patient felt fatigued. Patient suffered fall on 01Feb2021. She was admitted to hospital. All cell lines were down in Feb2021. She was diagnosed with AML (acute myeloid leukemia) in 2021. She expired 07Feb2021. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event) and patient died. The patient received the treatment of blood and platelet transfusions, bone marrow biopsy, cytogenetic testing, antibiotics, intubation for events. The patient died on 07Feb2021 due to sepsis secondary to AML. An autopsy was not performed. Outcome of events were fatal.; Reported Cause(s) of Death: arm pain; fatigued; fall; Sepsis secondary to AML; Sepsis secondary to AML	No current illness for this event.	1035539-1	80+ years	2021/02
228	PFIZER\BIONTECH	Chest tightness; SOB; This is a spontaneous report from a contactable pharmacist. A 33-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0142) intramuscular, in left arm, on 02Feb2021 at 15:00, for COVID-19 immunisation. The patient received the first dose of BNT162B2 on 14Jan2021 at 19:30, from lot EL3302, intramuscular, in left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. Medical history included lymphoid leukemia, allergies to asparaginase and pegaspargase (anaphylaxis), vancomycin, fluticasone propionate (FLONASE). Concomitant medications were not reported. The patient waited 30 minutes in clinic. As she was exiting, she felt chest tightness and SOB starting from 02Feb2021 at 15:15. Rapid response called. She was evaluated by RR and dc'd back to clinic. Chest tightness improved. Refused ED. No treatment was administered. The events were reported as non-serious and resolved on an unspecified date in Feb2021.	No current illness for this event.	1037939-1	30-39 years	2021/02
229	PFIZER\BIONTECH	Chest pain; shortness of breath; pain radiating down left arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 06Feb2021 12:00 at single dose in left arm for COVID-19 immunisation. Medical history included allergies to iodinated contrast, chronic lymphocytic leukaemia (CLL), herniated discs. The patient didn't have COVID prior vaccination. Concomitant medications included tamsulosin hydrochloride (FLOMAX), sertraline hydrochloride (ZOLOFT), valacyclovir, ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER). The patient previously received the first dose of bnt162b2 on 16Jan2021 02:00 PM in left arm for COVID-19 immunisation. There were no other vaccine in four weeks. The patient experienced chest pain, shortness of breath, pain radiating down left arm. Adverse events start from 07Feb2021 05:45 AM. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and hospitalization for 1 day. Treatment was received for the events. The patient underwent lab test which included Blood tests, EKG on unknown date. The outcome of the events was recovering. COVID was not tested post vaccination.  Information on Lot/Batch has been requested.	No current illness for this event.	1039929-1	50-59 years	2021/02
230	PFIZER\BIONTECH	he has chronic myeloid leukemia - white blood cell count is higher; His oxygen is low; Blood clot in his legs; first dose on 19Jan2021 and second dose on 02Feb2021; first dose on 19Jan2021 and second dose on 02Feb2021; This is a spontaneous report from a contactable nurse reported for her father that an 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunisation. Medical history included chronic myeloid leukemia (CML). Concomitant medications were not reported. Patient previously received first dose of BNT162B2 on 19Jan2021 at single dose for covid-19 immunisation. Patient received Pfizer-BioNTech COVID-19 Vaccine first dose on 19Jan2021 and second dose on 02Feb2021. Two days after second dose (04Feb2021) he had to go to the hospital - he had chronic myeloid leukemia - white blood cell count was higher (Feb2021), he had been in the hospital for the last 3 days as of 08Feb2021, his oxygen was low, had a blood clot in his legs, had a bone marrow biopsy, all on an unspecified date in Feb2021. The nurse is taking its related to this vaccine and assessed this case as not serious.  Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.	No current illness for this event.	1048205-1	Unknown	2021/02
231	PFIZER\BIONTECH	White blood cells went up greatly; Blood clots in his legs; oxygen went down/oxygen levels went down; This is a spontaneous report from a contactable consumer (patient's daughter). A male patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included he had Leukemia and was on treatment. The patient's concomitant medications were not reported. The patient took first dose bnt162b2 for COVID-19 immunization. Caller says that her father got his second COVID vaccine from Pfizer. He wound up in the hospital 3 days later. His white blood cells went up greatly and he has blood clots in his legs. They do not know what is happening. They are very worried about him. He is getting a bone marrow test today (08Feb2021). His oxygen went down yesterday (07Feb2021) and is now on oxygen. She is freaking out about it. She really thinks it has to do with vaccine. It was asked if there was any information on other people with Leukemia getting the vaccine. If what research there was on this. They need all the help and information they can get. Every minute counts as everything getting worse. He is now on oxygen as his oxygen levels went down. He is getting worse every hour. The patient underwent lab tests and procedures which included oxygen saturation: his oxygen went down yesterday/oxygen levels went down on 07Feb2021, white blood cell count: his white blood cells went up greatly on an unknown date, biopsy bone marrow: unknown results on 08Feb2021. Reporter seriousness for White blood cells went and Blood clots in his legs up greatly was hospitalization. Therapeutic measures were taken as a result of oxygen went down. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.	No current illness for this event.	1048691-1	Unknown	2021/02
232	PFIZER\BIONTECH	hard on hearing/lost his hearing; pain in his right ear; Chills; headache; Fever; Weakness; lacking appetite; This is a spontaneous report from a contactable consumer (patient's wife). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9810, expiration date was not reported) (at 86 years of age), via an unspecified route of administration in the left arm on 03Feb2021 15:00 at a single dose for COVID-19 immunization. Medical history included ongoing chronic lymphocytic leukaemia, ongoing blood pressure abnormal and ongoing thyroid disorder. Concomitant medication included hydrochlorothiazide which he was taking for years, ibrutinib which he was taking for 7 years, levothyroxine which he was taking for 10 years and losartan which he was taking for 8 years. The patient had no any other vaccine prior to covid vaccine. It was reported that the patient received the Pfizer covid vaccine on 03Feb2021. 24 hours later (04Feb2021), he experienced pain in the ears, headache, chills, and fever up to 101.5 for almost a week now, and currently is hard on hearing and had been feeling weak and lacking appetite. It was added that a week ago he received the first dose of the Pfizer COVID 19 vaccine on 03Feb2021 at 1500PM in the left arm. Within 24 hours the side effects started. He had a pain in his right ear and a headache. Since then he has gradually lost his hearing in that ear and they are following up with an ear nose and throat doctor. On 04Feb2021, he got a fever of 101.5, chills, weakness and no appetite. Since then in the evening he had been having kind of a fever of 100 to 100.5 and she has treated with TYLENOL. The fever comes and goes. In the morning he was normal. Adds his appetite was better but he still has to force himself to eat. She queried if should the patient get the second dose of the vaccine. Patient is scheduled to receive the second dose on 04Mar2021. The patient did not visit the ER. The patient underwent lab tests and procedures which included body temperature: up to 101.5, fever of 100 to 100.5, and 101.5 on 04Feb2021.  The outcome of the event loss of hearing, fever, weakness, and pain in his right ear was not recovered; headache and chills are recovered on 05Feb2021; while recovering for lacking appetite. The loss of hearing was reported as worsened. Therapeutic measures were taken as a result of fever (pyrexia).	Blood pressure abnormal; Chronic lymphocytic leukaemia; Thyroid disorder	1051002-1	80+ years	2021/02
233	PFIZER\BIONTECH	grade 2 allergic reaction; short of breathe; flushed; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; This is a spontaneous report from a contactable other healthcare professional. A 79-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9262, NDC number of COVID Vaccine: 59267-1000-1; Expiry Date of COVID Vaccine: 31May2021), intramuscularly at Left Deltoid on 08Feb2021 10:30 (either 10:30AM or within that hour or prior) at single dose for COVID-19 immunization. Medical history included anxiety, panic disorder, asthma, obstructive sleep apnea, additional Information for Other Conditions: She was oxygen Dependent, coeliac disease, allergy, Additional Information for Other Conditions: She had Medication, Environmental, and Food Allergies, central neuro hearing loss, vertigo, Allergic rhinitis, gastrooesophageal reflux disease (GERD), Additional Information for Other Conditions: Esophageal Reflux, osteopenia, impaired glucose tolerance, hypothyroidism, claustrophobia, rheumatoid arthritis (she had arthritis for which she took Orencia for), history of coronary heart disease, diabetes, she would be a targeting patient, as she was an oncology patient with large granular lymphocytic leukemia she met criteria for the pandemic, as well as they put down that she was due for immunization. She had anaphylaxis to bees. With adhesive tapes she got dermatitis. With shellfish she got hives. She had a gluten sensitivity and with mango her mouth gets fuzzy. Family Medical History Relevant to AE(s): her sisters had a few cancer. There were no concomitant medications. The patient previously received levofloxacin she had hives, with quinolones drug class she had hives, with thiopental she had hives and needed IV Decadron for it, with sertraline she has syncope, with Revatio she had an adverse event of joint and muscle pain, with ciprofloxacin she had tachycardia, with Enbrel it caused a drug induced pulmonary fibrosis granulomatosis, with Montelukast she had a headache and muscle pain, nitrofurantoin she had headache, with Symbicort it gave her hoarseness, she took Orencia for arthritis, she got the flu Vaccine in Sep2020. That was most recent. The patient had a grade 2 allergic reaction on 08Feb2021. The patient was watched after administering the vaccine on 08Feb2021 as she had background of multiple allergies and asthma. She was watched for 30 minutes in the oncology unit infusion suite. The reaction happened within 5 minutes of administration. Seriousness Criteria: Caller explained that this reaction was mild to moderate, there was a grade to intervene but at no point was she unstable, she did have a significant anxiety disorder, and so she was nervous about getting the vaccine. She was short of breathe, odd and flushed. She was physically stable, her vitals were stable and there was no angioedema. Reporter seriousness for grade 2 allergic reaction: Medically significant. The patient recovered, as a treatment they gave her IV Benadryl 50mg and IV fluids, she also had her own albuterol inhaler. In the pandemic, they are not doing nebulizers. The outcome of events allergic reaction, shortness of breath and flushed was recovered on 08Feb2021. Relatedness of drug to reaction(s)/event(s). Reaction assessed: Grade 2 allergic reaction; Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related. Causality: reporter stated that she did think the patient's base line anxiety played into the reaction she experienced, the reaction was aggravated by it.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of grade 2 allergic reaction, short of breathe and flushed due to temporal relationship and current known drug safety profile. The patient's underlying allergic physique also predisposed the patient to developing the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.	No current illness for this event.	1051446-1	65-79 years	2021/02
234	PFIZER\BIONTECH	My arm was sore that night and it's still very sore today. Because of my leukemia I have enlarged lymph nodes and the lymph nodes under my arm has been very, very sore. I've had fevers, chills and fatigue. My stomach has been upset since the vaccine and my appetite has been decreased.	No	1051992-1	65-79 years	2021/02
235	PFIZER\BIONTECH	Patient was positive of COVID 19 in between doses; Patient was positive of COVID 19 in between doses; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (parent).  A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history included T-cell lymphoblastic leukemia acute (in remission). Concomitant medications were unknown. On an unspecified date, after the first dose, the patient was tested positive for COVID 19. It was confirmed that patient was positive of COVID 19 in between doses. Clinical outcome was unknown at time of this report.  The information on the lot number has been requested.	No current illness for this event.	1053620-1	Unknown	2021/02
236	PFIZER\BIONTECH	injection site started itching; Strange area around injection site about size of silver dollar, red around outer rim and kind of orangeish colored in the middle; Strange area around injection site about size of silver dollar, red around outer rim and kind of orangeish colored in the middle; feel extremely unwell; feverish 97.5-97.6 degrees Fahrenheit; tired; This is a spontaneous report from a contactable consumer (patient). A 92-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (upper arm) on 20Jan2021 11:00 (at the age of 92years) at single dose for Covid-19 immunization. Medical history included breast cancer, second right breast lumpectomy related to breast cancer from 16Oct2020 to an unknown date, first right breast lumpectomy related to breast cancer on an unknown date (done about 3-4 years prior to second right breast lumpectomy related to breast cancer), on blood thinner, allergic to the statins and allergy to unknown product (She was once given something, some medication for her heart, but about 5- 6 weeks later she developed a reaction to it so she was taken off the medication but does not remember the name of the drug.) The patient would consider herself obese at this weight, but that is probably because she was always very thin historically; her doctor has never diagnosed her as being obese or advised her to lose weight. The patient's daughter had a very, very aggressive form of breast cancer-she is deceased 11 years. Patient's younger sister had breast cancer; there is a lot of breast cancer on her husband's side- his mother, sister, niece all had breast cancer, they have a big history of breast cancer; other types of cancer in patient's family include her mother who died of pancreatic cancer in her 80s; and her dad had prostate cancer but he was in his upper 80s; and patient's older sister died of leukemia. Concomitant medications included warfarin from an unspecified date at 5 mg (daily x 2 days/week) then 2.5 mg (daily x remaining 5 days/week) as blood thinner and metoprolol from an unspecified date at 25 mg, 2x/day (morning and evening) for an unspecified indication. The patient previously had Flu shot. The patient reported that she got on last Thursday (21Jan2021) the first dose of the Covid 19 vaccine at 11 o'clock. She did not feel anything wrong at the moment (also reported as she had no immediate reaction at all). A couple of days after (About maybe 2-3 days later sort of in the middle of the day, not the morning) she started to feel extremely unwell, feverish (although thermometer did not indicate any raise) tired and malaise she was really surprised because it occurred that long after administration. She took Tylenol and she was looking to know if this has been reported as a side effect of the vaccine and how to treat it. She was very concerned about it because she has never had an adverse event with any vaccine or inoculation before. She takes a yearly flu shot and never had any reaction. Feverish: She has taken her body temperature with her digital thermometer which does not show a fever, it shows like 97.5-97.6 degrees Fahrenheit so not a fever; but she feels feverish. On 26Jan2021 the injection site started itching and she looked at site which is way up high so she can't turn her neck that way; but found a strange area around the injection site that is about the size of a silver dollar, red around the outer rim and kind of orangeish colored in the middle. She has never had that occur before, and the skin in the middle of the area, the orangeish colored area has no pain. She reported that there was a mass of people at the location where she was administered the Pfizer COVID-19 Vaccine. There were hundreds of people there when she was for inoculation event so she is wondering if she could have picked up COVID while there. She called to ask about these events related to the product.  She has no major allergies. The patient underwent lab tests and procedures on an unspecified date which included body temperature: 97.5-97.6-degree Fahrenheit. The outcome of events was unknown.  Information on the lot/batch number has been requested.	No current illness for this event.	1061940-1	80+ years	2021/02
237	PFIZER\BIONTECH	eyelids became puffy; eyes became glassy; fever; body aches; chills; bad headaches; implanted breast skin became blotchy; This is a spontaneous report from a contactable consumer, the patient.  A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E63247) , via an unspecified route of administration in the right arm on 01Feb2021 at 15:00 (at the age of 70-years-old) as a single dose for COVID-19 immunization.  Medical history included Raynaud's syndrome, chronic lymphocytic leukaemia, irradiated thyroid gland, high cholesterol, previous breast cancer, allergy to latex and adhesives, and breast implants.  Concomitant medications included levothyroxine sodium (SYNTHROID); rosuvastatin (MANUFACTURER UNKNOWN), and unspecified multivitamins.  The patient previously took povidone/iodine (BETADINE) on unknown dates for an unknown indication and experienced drug allergy.  On 05Feb2021 at 21:00, the patient experienced fever, body aches, chills, bad headaches, and implanted breast skin became blotchy.  On 07Feb2021, the patient's eyelids became puffy and eyes became glassy,. All the events were reported as serious for disability. The peak temperature was 101 degrees Fahrenheit on an unknown date in Feb2021. The patient contacted the doctor, eye care professional and hematologist/oncologist for the events. On 08Feb2021, the patient had a COVID-19 nasal swab PCR which was negative. The patient was not treated for the events.   The clinical outcome of the fever was recovered on 12Feb2021; while that of the body aches, chills, bad headaches, implanted breast skin became blotchy, eyelids became puffy, and eyes became glassy were recovering.	No current illness for this event.	1062225-1	65-79 years	2021/02
238	PFIZER\BIONTECH	Patient is an 80 year old male who has a history of multiple medical problems, including body mass index of 30, hypertension, dyslipidemia, giant-cell arteritis on a slow prednisone taper (currently 2 mg daily), past pulmonary embolism on warfarin, sleep apnea, history of diverticulitis (treated in August 2020), past abdominal surgeries (including umbilical hernia repair +2 and open recurrent incarcerated epigastric hernia repair with mesh in October 2020), chronic anemia, and type-2 diabetes.  The patient had received the first dose of the COVID-19 (SARS-CoV-2) vaccine on January 31, 2021 and the second dose on February 21.  He presented to his primary care provider?s office on February 22, 2021 with complaints of 10 days of progressive weakness and muscle soreness.  The weakness had reportedly involved the bilateral thighs and arms and was associated with muscle aches.  Blood pressure measured 90/40 mmHg and examination was notable for symmetrical proximal weakness in the upper and lower extremities.  The peripheral blood leukocyte count measured 3.5 x10e3/ªL, hemoglobin 8.3 grams per deciliter and platelets 147 x10e3/ªL.  A peripheral blood smear was consistent with neutropenia and normocytic anemia with 9% circulating blasts.  Total CK measured 1424 U/L.  The patient was referred to hematology/oncology and rheumatology and had appointment scheduled for both on February 26.    With the above background, he presented to emergency room on February 24 with altered mental status and continued weakness.   He was taken to the hospital by emergency medical services.  A temperature of 103 degrees Fahrenheit was recorded when emergency medical personnel had arrived. The peripheral blood leukocyte count was 1.4 x10e3/ªL for an ANC of 0.8 x10e3/ªL.  Hemoglobin was 8.1 g/dL and platelets 111 x10e3/ªL.  A few schistocytes and teardrop cells were noted. The serum creatinine was 1.47 mg/dL.  AST was 174, ALT 91 and alkaline phosphatase 93 U/L.  The lactic acid level of the venous blood was 2.1 mmol per liter.  A repeat total CK was 4631 U/L.  Sedimentation rate measured 34 mm/h and CRP 52.3 mg/L.  Urinalysis showed 0-2 wbc?s/hpf, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, negative leukocyte esterase.  A haptoglobin level of the blood was within normal limits. The lactic acid level of the venous blood was 2.0 mmol/L.  LDH measured 838 U/L.  A ferritin level was 3464 nanograms/mL.  A test for COVID-19 (SARS-CoV-2) was negative.     A chest radiograph showed minimal streaky right basilar atelectasis, trace left effusion and a mildly enlarged cardiac silhouette.  A head CT showed no acute abnormality.  An abdominopelvic CT without contrast was limited by motion artifact.  No acute intra-abdominal or pelvic finding was noted.  Nonspecific soft tissue stranding was seen in the right inguinal region.  There was no soft tissue gas or drainable fluid collection.  Cultures of specimens of the blood were obtained.  The patient was started on empiric cefepime, vancomycin and doxycycline and admitted for further care. A peripheral blood smear for intracellular parasites was negative.  The admission blood cultures came back positive for E. coli. With the blood culture results, the vancomycin and doxycycline were discontinued.  The E. coli isolate has since been determined to be pansusceptible.  A MRSA PCR of the nares was negative.   He was found on exam to have swelling, cellulitis and exquisite pain of the right groin area on February 25.  Surgical consultation was pursued.  They did not feel that he had necrotizing fasciitis.  The CT scan of the abdomen and pelvis was repeated with contrast, revealing increased extensive subcutaneous edema of the right groin region with extension into the thigh musculature and mild extension into the right inferior pelvis.  There was no associated soft tissue gas or drainable abscess. A bone marrow biopsy was performed February 25.  Results showed acute undifferentiated leukemia with 60-70% infiltration of the bone marrow with blasts.  The blasts were negative for lineage markers.  He was faintly CD33 positive.  He is felt to likely have acute myeloid leukemia. Cytogenetics are pending.	Patient had been having progressive fatigue, malaise, and weakness for 2-3 months prior to admission to the hospital on 2/24/21.	1063882-1	80+ years	2021/03
239	PFIZER\BIONTECH	acute myeloid leukemia; This is spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 16Jan2021 at 13:00 (at the age of 80-years-old) at single dose in left arm for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 28Dec2020 at 13:00 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Workplace clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has known allergies to penicillin. The patient received no concomitant medications. The patient experienced acute myeloid leukemia. Onset date of the event was reported as 16Feb2021 at 08:00. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, Life threatening illness (immediate risk of death from the event). The paitent was hospitalized for 7 days and was treated with Leukopheresis, Hydrea, Chemotherapy, Vancomycin. The patient had not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.  Information about batch/lot number has been requested.	No current illness for this event.	1065922-1	80+ years	2021/02
240	PFIZER\BIONTECH	bilateral blood clots in legs that then went to lungs then went into BLAST crisis; bilateral blood clots in legs that then went to lungs then went into BLAST crisis; bilateral blood clots in legs that then went to lungs then went into BLAST crisis; Patient with myeloid leukaemia (CML) and WBCs abnormal received BNT162B2; Patient with myeloid leukaemia (CML) and WBCs abnormal received BNT162B2; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiration date unknown) via an unspecified route of administration in the left arm on 02Feb2021, 13:00PM (at 82 years old) at a single dose for COVID-19 immunization. The patient was vaccinated in the Nursing Home/Senior Living Facility. The patient's medical history included myeloid leukaemia (CML) diagnosed a few months earlier, WBCs abnormal, blood pressure, and heart surgery valve repair. The patient has no known allergies. Concomitant medications included atorvastatin, carvedilol, vitamin d nos, dasatinib monohydrate (SPRYCEL) from an unknown date to help get WBCs back in normal range; cyanocobalamin (VITAMIN B12), and cetirizine hydrochloride (ZYRTEC), all were received within 2 weeks of vaccination. At 82 years old, the patient received the first dose of BNT162B2 (lot number and expiration date unknown) via an unspecified route of administration in the left arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior to vaccination and did not receive any other vaccines within 4 weeks prior to BNT162B2. It was unknown if patient was tested for COVID post vaccination. On Friday (unknown date in Feb2021), patient's WBC was 150,000 and on Saturday (unknown date in Feb2021), patient had bilateral blood clots in legs that then went to lungs then went into BLAST crisis. The adverse events resulted in emergency room/department or urgent care as well as hospitalization due to life threatening illness (immediate risk of death from the events). The patient was hospitalized for 12 days. Therapeutic measures which include steroids, blood thinners, and lots of other meds were administered. Outcome of the events ""patient's WBC was 150,000"" and ""bilateral blood clots in legs that then went to lungs then went into BLAST crisis"" was recovering.  Information on the lot/ batch number has been requested.""	No current illness for this event.	1068264-1	80+ years	2021/03
241	PFIZER\BIONTECH	acute myeloid leukemia; her platelets were below 30,000; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 12Feb2021 at single dose for COVID-19 immunization. Medical history included ongoing immunodeficiency (reported as immunocompromised). Concomitant medications were not reported. The patient had an acute myeloid leukemia and her platelets were below 30,000 on an unspecified date. Clinical outcome of the events was unknown.  Information on about lot/batch number has been requested.	No current illness for this event.	1070724-1	Unknown	2021/03
242	PFIZER\BIONTECH	Patient received dose 1 and dose 2 of the COVID 19 vaccine, 2/2/21 (Lot EL9265, Pfizer)  and 2/24/21 (Lot EN6202, Pfizer), on 2/28/21 patient presented to the Emergency Department at our facility. CBC lab test was abnormal, possible Leukemia, patient transferred to Medical Center for further evaluation and treatment. Patient expired on March 2, 2021.	Unknown	1073435-1	50-59 years	2021/03
243	PFIZER\BIONTECH	Blood sugar went up; This is a spontaneous report from a contactable consumer (patient) via medical information team and a Pfizer-sponsored program . A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown) via an unspecified route of administration on 11Feb2021 at single dose to prevent COVID-19 virus. Medical history included that he was legally blind and he did not drive; his oncologist told him to take the Pfizer COVID-19 Vaccine because he has Leukemia, to prevent the COVID-19 virus that has been going around; this consumer was a type II diabetic and he took his blood sugar every morning. The patient's concomitant medications were not reported.  He had an injection of BNT16B2 on 11Feb2021 afternoon and his blood sugar spike up on 12Feb2021. The outcome of event was unknown.  Information on batch number has been requested.	No current illness for this event.	1090212-1	Unknown	2021/03
244	PFIZER\BIONTECH	itching of scalp; forehead had slight swelling; cold sore; This is a spontaneous report from a contactable consumer (patient).  A 68-years-old male patient received second dose for bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EN5318), via an unspecified route of administration, on the left arm, on 29Jan2021 at 12:00 at a single dose for Covid-19 immunization. Medical history included chronic lymphocytic leukaemia (CLL), chronic acid reflux, and Caisson's sickness. The patient has no known allergies. The patient has other unspecified medications taken in two weeks. The patient previously took his first dose of bnt162b2 (lot no. EN3246) on 08Jan2021 at 12:00 PM, on the left arm for Covid-19 immunization. The patient has not taken other vaccine in four weeks. On 02Feb2021 at 21:00, several days after vaccine had strong itching of scalp, lasting several hours prior to bedtime. Noticed that his forehead had slight swelling at bedtime. Overnight this cleared up, patient had taken valcyclovir the prior day for a cold sore. He was reporting this, but may be a red herring. The patient has no Covid prior vaccination and not Covid tested post vaccination. Outcome of the events was recovered on an unspecified date in 2021.	No current illness for this event.	1100319-1	65-79 years	2021/03
245	PFIZER\BIONTECH	they got the virus; is still weak; This is a spontaneous report from a contactable consumer (patient's daughter) via Medical Information Team. This consumer reported similar events for two patients. This is the first of two reports.  An 89-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included leukaemia. The patient's concomitant medications were not reported. The reporter reported that her parents received the first dose of bnt162b2 vaccine. Then, after a week, they got the virus on an unspecified date. The reporter said that they got it from the doctor's office. The reporter also mentioned that her parents are still recovering and are still on quarantine. The reporter also mentioned that her father who has leukemia, was still weak and was under hospice care on an unspecified date. The reporter wanted to know if they should still receive the 2nd dose of the vaccine. The reporter was also concerned because they were scheduled to receive the 2nd dose 3 days earlier than the recommended 3-week-interval, and wanted to know if that was acceptable. The patient was recovering from all the events.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021170461 same reporter/drug, similar event, different patient	No current illness for this event.	1100334-1	Unknown	2021/03
246	PFIZER\BIONTECH	have very low IgG (374); My concern is I did not make any antibody because I don't have any; This is a spontaneous report from a contactable physician (the patient).  This 73 year-old male patient received the first dose of BNT162B2  (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose, the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose, both for COVID-19 immunization. Medical history included chronic lymphocytic leukaemia.  The patient's concomitant medications were not reported. The patient reported, ""I received both Pfizer vaccines 19 days apart, waited a month and got a spike protein antibody test. I have very low IgG (374), when I got my series of Hep B 3 injections I had 0 antibodies. He stated ""I see now your vaccine is now effective with variants. My concern is I did not make any antibody, because I don't have any. My concern is my low IgG"". The patient had lab tests and procedures in Feb2021 which included antibody test: negative, ""I had 0 antibodies"", blood immunoglobulin G: 374, very low. The clinical outcome of the events was unknown.   Information on the lot number has been requested.""	No current illness for this event.	1100386-1	Unknown	2021/03
247	PFIZER\BIONTECH	Pain on injection site, other arm; fever; terrific headache; aching ness; This is a spontaneous report from a contactable nurse (patient). A 77-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 03:00 am at single dose at left arm for covid-19 immunization. Medical history included asthma, cll (chronic lymphocytic leukaemia), sulfa allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took prochlorperazine maleate (PCP) and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The patient experienced pain on injection site, other arm, fever both on 05Feb2021 with outcome of recovered on the same day, terrific headache for three days, aching ness for two days both on 05Feb2021 with outcome of recovered on unspecified date in Feb2021. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.    Information on the batch/lot number has been requested.	No current illness for this event.	1100444-1	Unknown	2021/03
248	PFIZER\BIONTECH	patient was admitted for covid-19, CTA positive for covid-19 pneumonia and covid-19 PCR positive, after 2 completed doses of Pfizer vaccine.; patient was admitted for covid-19, CTA positive for covid-19 pneumonia and covid-19 PCR positive, after 2 completed doses of Pfizer vaccine.; covid-19 pneumonia; This is a spontaneous report from a non-contactable other HCP.  An 87-year-old male patient received on an unknown date the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot unknown) and on 11Feb2021 the second dose (30mcg/0.3mL, lot unknown), both via an unspecified route of administration for COVID-19 immunization (age at vaccination 87-year-old). Medical history included: Chronic lymphocytic leukaemia (CLL) and hypogammaglobulinemia. Concomitant medication was not reported. The patient was recently admitted for covid-19, CTA positive for covid-19 pneumonia and covid-19 PCR positive, after 2 completed doses of Pfizer vaccine. On 23Feb2021 (post vaccination), the patient's COVID test nasal swab was positive. Patient did not have COVID prior vaccination. Outcome of events was unknown.  No follow-up attempts are possible; information about Lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Covid-19 , COVID 19 pneumonia and vaccination failure due to temporal relationship.	No current illness for this event.	1102132-1	80+ years	2021/03
249	PFIZER\BIONTECH	Patient was vaccinated with the Pfizer vaccine in early February.  On February 19th, she was diagnosed with Acute Myeloid Leukemia	statin--muscle weakness	1103186-1	65-79 years	2021/03
250	PFIZER\BIONTECH	lymph nodes under arm pits feel like golf balls was reported as worsened/lymph nodes under arm feel like golf balls was reported as worsened; lymph nodes under her arm pits and under her arm feel like golf balls/lymph nodes in neck swollen; Fever is 99.6 this morning; hurt all over from her toes to her fingers and from her fingers to her toes; lack of sleep; Headache; Chills; feels like wires are squeezing and pressing her/Feels awful; This is a spontaneous report from a contactable consumer.  A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 13:00 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia Diagnosed with it 5-6 years ago, ongoing chronic lymphocytic leukaemia Diagnosed almost a year ago. The patients concomitant medications were not reported. The patient experienced, lack of sleep on 05Feb2021 21:00. It was reported that she got the vaccine more than 48 hours ago. Stated that she feels awful on 05Feb2021 10:00. Stated that she has a fever on 06Feb2021, chills and headache on 05Feb2021 19:00, hurt all over from her toes to her fingers and from her fingers to her toes on 05Feb2021 22:00. Stated that she is in a lot of pain and that it feels like wires are squeezing and pressing her on 05Feb2021. Stated that it is horrible. Stated that the lymph nodes under her arm pits and neck feel like golf ball under arm and arm pit on 06Feb2021 12:00. Stated today the doctor will see her because it will have been 3 days in a few hours. Clarified that this is for the Covid vaccine. Stated that she is working in a retirement place with an older person. Stated that they decided to give to it to her. Stated that she asked her doctor and he told her that it was okay. Later clarified that the lymph nodes in her neck are just swollen and the lymph nodes under her arm pits and under her arm feel like golf balls. Stated that her fever is 99.6 this morning (06Feb2021). Stated that it improved when she took three Advil (600mg). Stated that she feels like wires are squeezing and pressing her again when the Advil wears off. Was told to alternate with Tylenol and is taking a lot of liquids. Clarified that she thought that the pain was fibromyalgia but that it felt worst than fibromyalgia. Stated that the lack of sleep improved because she takes a higher dosage of Advil or Ibuprofen for sleep. Outcome of the event fever is 99.6 this morning, hurt all over from her toes to her fingers and from her fingers to her toes, feels awful, lack of sleep recovering. Outcome of the event lymph nodes under arm feel like golf balls was reported as worsened (Condition worsened) was unknown. Outcome of the other events was not recovered.   Information on the lot/batch number has been requested.	Chronic lymphocytic leukemia (Diagnosed almost a year ago. Verbatim: chronic lymphoma leukemia); Fibromyalgia (Diagnosed with it 5-6 years ago. Verbatim: Fibromyalgia)	1106223-1	40-49 years	2021/03
251	PFIZER\BIONTECH	Fever of 101.4; Chills; Aches; Fatigue; This is a spontaneous report from a contactable consumer.  A 76-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL9263) as SINGLE DOSE for an unspecified indication.  Medical history included ongoing acute myeloid leukaemia, ongoing hypertension. Concomitant medications included gilteritinib fumarate (XOSPATA) taken for an unspecified indication, start and stop date were not reported; timolol taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; latanoprost (LATANOPROST) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced fever of 101.4 (pyrexia) (non-serious) on 30Jan2021 10:00, chills (chills) (non-serious) on 30Jan2021 10:00, aches (pain) (non-serious) on 30Jan2021 10:00, fatigue on 30Jan2021 10:00.  The patient underwent lab tests and procedures which included body temperature: 101.4 on 30Jan2021.  There was not treatment received for the adverse events. The events were considered as non-serious by the other healthcare professional. The outcome of the events were reported as recovered.	Acute myeloid leukemia; Blood pressure high	1106232-1	65-79 years	2021/03
252	PFIZER\BIONTECH	Shingles; This is a spontaneous report from a contactable consumer.  A 74-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in the right arm, on 23Jan2021 (Batch/Lot Number: EN9581; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunization.  Medical history included rosacea, rash and CLL (chronic lymphocytic leukaemia); patient has history of CLL (leukemia) in remission for 6 years. Concomitant medications included hydroxychloroquine taken for rash, start and stop date were not reported; and doxycycline taken for rosacea, start and stop date were not reported.  The patient experienced shingles (herpes zoster) (non-serious) on 13Feb2021. The patient underwent unspecified lab tests and procedures which patient did earlier in Jan and stated that ""all of it was fine"".  The outcome of event was unknown. Therapeutic measures were taken as a result of shingles included Valtrex.  No follow-up attempts are possible. No further information is expected.""	No current illness for this event.	1114347-1	65-79 years	2021/03
253	PFIZER\BIONTECH	blood blisters; nose bleed; I had petichiae all over legs and arms; showed platelets at 7000/showed zero platelets; very sick; fever and chills; fever and chills; achy all over; This is a spontaneous report from a contactable consumer (patient).  This 89-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9810), via an unspecified route, on 12Feb2021 (at 12:15) at a single dose on right arm for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261) administered on right (R) arm on 22Jan2021 at 10:15 AM. No other vaccine was received in four weeks. Relevant medical history includes acute myeloid leukemia, allergy to fish and NSAIDS. Past drug history included allergy to penicillin and erythromycin. Relevant concomitant medications included aciclovir (ACYCLOVIR), amiodarone, fluconazole, furosemide (LASIX) and oxitriptan (LEVOTHYM). The patient became very sick after vaccine with fever and chills and achy all over for 4 days, then on the 7th day her blood test showed platelets at 7000. On 19Feb2021 (at 17:00), she had petichiae all over legs and arms and blood blisters and nosebleed for 2 hours. She visited emergency room (ER) were blood tests showed zero platelets so she was hospitalized on 19Feb2021 for 3 days. She was infused with 5 units of plasma and she received also dexamethasone. The events were considered serious because requiring hospitalization on 19Feb2021 and also as life-threatening conditions. On 20Feb2021, the patient underwent a COVID test which resulted negative. The patient had not recovered from the events.	No current illness for this event.	1115270-1	80+ years	2021/03
254	PFIZER\BIONTECH	72 year old, male with past medical history significant for Parkinsons and internal hemorrhoids w/band ligation and recently vaccinated for COVID who then developed tibial rash and gingival bleeding. Platelets notably 2. Fibrinogen normal 357/unlikely DIC, Coags normal,  LDH normal unlikely TTP or MAHA and bilirubin normal, Retic also normal (not aplastic anemia), unlikely leukemia, smear unremarkable.  HIV negative, Hep panels. Some anemia, pending iron studies.Pending ANA /other labs. Do not suspect leukemia.  Suspect ITP	No current illness for this event.	1115498-1	65-79 years	2021/03
255	PFIZER\BIONTECH	Chills; Fever; Pounding headache; Swollen lymph nodes on left side; This is a spontaneous report from a contactable consumer.   A 61-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 09:45 AM (Batch/Lot Number: EL3247), at the age of 61-year-old at the time of vaccination, as SINGLE DOSE for covid-19 immunisation  .  Medical history included chronic lymphocytic leukaemia (CLL) and former breast cancer. Concomitant medication included tamoxifen 20 mg taken for an unspecified indication, start and stop date were not reported. The patient received dose 1 of vaccine on 15Jan2021 01:00 PM at left arm, lot number: EL1283. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. On 05Feb2021 22:00, the patient experienced chills, fever, pounding headache, swollen lymph nodes on left side. The outcome of the events was recovered. The patient took Tylenol as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19.	No current illness for this event.	1119934-1	60-64 years	2021/03
256	PFIZER\BIONTECH	Bilateral pulmonary embolism; hypertension; shortness of breath; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via an unspecified route of administration on 25Feb2021 at age of 75-year-old at single dose for COVID-19 immunisation. Medical history included chronic lympocytic leukemia, stem cell transplant recipient, and prostate cancer. Known allergies: possibly penicillin. No COVID prior vaccination. The patient's concomitant medications were not reported. The patient experienced bilateral pulmonary embolism, hypertension, and shortness of breath on 02Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. It was unknown if treatment received for the events. It was unknown if COVID tested post vaccination. The outcome of the events was unknown.  Information on the lot/batch number has been requested.	No current illness for this event.	1121596-1	65-79 years	2021/03
257	PFIZER\BIONTECH	Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021.  An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage	No current illness for this event.	1140696-1	65-79 years	2021/03
258	PFIZER\BIONTECH	Moderate to severe fatigue; I have trouble staying awake during the day, especially early evening.  I need more and longer naps than usual.  Because I have leukemia, I do have fatigue normally.; Moderate to severe fatigue; I have trouble staying awake during the day, especially early evening.  I need more and longer naps than usual.  Because I have leukemia, I do have fatigue normally.; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 19Jan2021 09:00 (Batch/Lot Number: EL3249) as single dose for Covid-19 immunization. Medical history included ongoing leukaemia, chronic pain, gastritis, colitis, supraventricular tachycardia, depression, xerostomia, afibrillation, migraines, fatigue, and others. Concomitant medication included ibrutinib (IBRUTINIB) taken for leukaemia. The patient previously had Known allergies for drugs Bactrim, Belladonna, Diclofenac, DMannose, IV contrast media, Mobic, Metoclopramide, Metoprolol, Protonix, and Pyridium. Patient not had other vaccine in four weeks, Other medications in two weeks includes Ibrutinib (for leukemia). On 19Jan2021 on 13:00, patient had Moderate to severe fatigue; ""I have trouble staying awake during the day, especially early evening. I need more and longer naps than usual. Because I have leukemia, I do have fatigue normally, but it has gotten Much worse"". Patient not had COVID prior vaccination; patient not tested COVID post vaccination. There was no treatment received for the adverse events. Th outcome of the events was not recovered.""	Leukemia	1150322-1	65-79 years	2021/03
259	PFIZER\BIONTECH	Knot detected in lymph node under right arm; Redness continues to spread after 6 days after receiving shot along with fever on this area; Redness continues to spread after 6 days after receiving shot along with fever on this area; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 05Mar2021 at 11:00 (Lot Number: EN6206) (at the age of 67-year-old) as single dose for COVID-19 immunisation.  Medical history included leukemia and penicillin allergy, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 06Mar2021, the patient experienced knot detected in lymph node under right arm and redness continues to spread after 6 days after receiving shot along with fever on this area. No therapeutic measures were taken as a result of the events. The patient outcome of the events was unknown.	No current illness for this event.	1153251-1	65-79 years	2021/03
260	PFIZER\BIONTECH	CAT scan showing lymphoma all over in his body; The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia; doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection; now he's basically unresponsive; This is a spontaneous report from a contactable consumer reported for patient (father). A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. There was no known allergies. Concomitant medications included blood pressure meds and pain meds. He previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 (at age of 77 years old) in the left arm for COVID-19 immunisation and got big lumps on his neck and began to feel ill. Four or five days after the first dose the patient got big lumps on his neck and began to feel ill he went to the doctor and they weren't too worried about it, he went back and got his second one in within three days (Mar2021) he was hospitalized after a CAT scan showing lymphoma all over in his body now he's basically unresponsive. The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection and can't figure out what is wrong with him he was perfectly fine before the vaccine.  AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient hospitalized for 5 days, no treatment received. COVID test received via nasal swab post vaccination (Mar2021): unknown result. Events outcome was unknown.  Information on the lot/batch number has been requested.	No current illness for this event.	1153547-1	65-79 years	2021/03
261	PFIZER\BIONTECH	leukemia; This is a spontaneous report from a contactable consumer (patient) . A 71-year-old female patient received BNT162B2 (Pfizer-COVID-19 Vaccine, Formulation: Solution for injection; Batch/Lot number: Not reported), first dose via an unspecified route of administration on 05Mar2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, stated she has leukemia and needs to go on treatment with Onureg, a low dose of 100 mg per day, starting Monday. She'll be getting her second shot of the Pfizer-COVID-19 Vaccine on Friday, and she asked if there could be a drug interaction between both treatments, there will be a 2-3 day difference between them. Stated ""it has nothing to do with the COVID-19 vaccine"" however she explained that leukemia cured and she was in remission prior to the COVID-19 vaccination. Responded per Full EUA PI Sections: 10 Drug Interactions; 5 Warnings and Precautions. LAB-1451-3.0. Outcome of event was recovered on an unspecified date in Mar2021.   Information on lot/batch number has been requested.""	No current illness for this event.	1153552-1	65-79 years	2021/03
262	PFIZER\BIONTECH	he is not getting any sleep; he had a rash and hives all over his body; itching; he had a rash and hives all over his body; sore arm; This is a spontaneous report from a contactable consumer reported for self. This 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 in the morning on Arm right at single dose (Lot # EN6205) for COVID Prevention. Medical history included ongoing leukemia CML from 2013, ongoing chronic lymphocytic leukemia from 2013, prostate cancer, white blood cell count runs high anyway, PSA (prostate specific antigen) last time he had blood work done, was 5.1. Concomitant therapy was none. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 26Feb2021 in the morning, in the evening (26Feb2021), he had a rash and hives all over his body, he also experienced sore arm. He states that he had itching sooner. He also has leukemia CML, his oncologist told him to receive the vaccine. He would like to know if he should receive the second dose of the vaccine, and get ready for rashes. He broke out in hives and it was really uncomfortable, and he was not getting any sleep. He states that the hives got so bad, it looks like he has alligator skin. He states that he took Benadryl (UPC: 81131 07825, Lot number: P113775, Expiry: Oct2020, he has been using the product since the expiry date) and used Cortisone, and it helped but did not work 100%, but it helped enough he got some sleep. He stated that he felt like it is getting better, but he was taking Benadryl, and when the Benadryl wears off, it starts doing it again, but it was bad at first, like alligator skin, so he does feel like it is improving some. Outcome of the event hives was recovering. Outcome of other events was unknown.	Chronic lymphocytic leukemia; Chronic myeloid leukemia	1154027-1	60-64 years	2021/03
263	PFIZER\BIONTECH	angioedema; lymphadenopathy, described as ""very impressive swelling"" at the base of neck that got inflamed when she got hot or stressed out, causing impacts on her swallowing; lymphadenopathy, described as ""very impressive swelling"" at the base of neck that got inflamed when she got hot or stressed out, causing impacts on her swallowing; lymphadenopathy, described as ""very impressive swelling"" at the base of neck that got inflamed when she got hot or stressed out, causing impacts on her swallowing; lymphadenopathy, described as ""very impressive swelling"" at the base of neck that got inflamed when she got hot or stressed out, causing impacts on her swallowing; This is a spontaneous report from a contactable pharmacist via Medical Information team. A 39-year-old female patient (nurse) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown, NDC number), via an unspecified route of administration at the age of 38 years on 18Jan2021 as a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. Relevant medical history included acute lymphatic leukemia (ALL) when she was 8 years old, but had been in remission since she was 13. The patient's concomitant medications were not reported. The pharmacy manager reported that the patient, who was one of her employees at the hospital, received her second dose of the Pfizer BioNTech COVID-19 vaccine on 18Jan2021 and on an unspecified date had experienced lymphadenopathy afterwards that was still ongoing. The reporter described it as ""very impressive swelling"" at the base of neck that got inflamed when the patient got hot or stressed out, causing impacts on her swallowing. The reporter stated that the patient had gone to the emergency room twice, where it had been described as angioedema on an unspecified date and had also seen an allergist, who described it as a ""robust immune response."" The reporter was concerned about the ongoing nature of this lymphadenopathy and would like any information that would help to treat this. The reporter also stated that the patient had gone through ""medical procedures and computerized tomography (CT) scans"" with unknown results on an unspecified date and would like to know if the patient would be eligible for the Program because of the event. The patient was in the group that got the vaccine first. The patient still had impressive lymphadenopathy and it was persisting. At first it was interfering with the patient's swallowing, but it was still occasionally interfering with her swallowing. The reporter was wondering if there was any more in house data that had been reported on this. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of angioedema, which included that the patient had been prescribed antihistamines, such as cetirizine (ZYRTEC), fexofenadine (ALLEGRA), hydroxyzine, famotidine (PEPCID), and methylprednisolone (MEDROL) dose packs. The patient was not recovered from the event ""lymphadenopathy,"" while the outcome of the rest of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of angioedema, lymphadenopathy and other events  due to temporal relationship.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.""	No current illness for this event.	1154031-1	30-39 years	2021/03
264	PFIZER\BIONTECH	tested positive for Covid; tested positive for Covid; loss of strength/ lack of stability/ weakness/he is still very weak; aches; drowsiness; loosing weight; lower leg edema; lethargic; still dizzy; triggered his immune system and his immune system is now one heck of a fight; swelling; loss of appetite; shortness of breath where he cannot walk; unable to walk; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 81, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from Oct2020 to an unknown date and was hospitalized for almost a week; chronic lymphocytic leukaemia (CLL) from an unknown date and unknown if ongoing, open heart surgery from an unknown date and unknown if ongoing and 'severe spines' from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 02Feb2021 for COVID-19 immunization and experienced light headiness, chills, dizziness, fever, tired, loss of appetite and very weak. The patient experienced lack of stability/loss of strength, aches, pains, difficulty breathing within 24 hours of the second dose in Feb2021 and was hospitalized. While in the hospital for two days, the patient underwent lab tests which included Sars-Cov-2 test after the second dose which came back positive. The patient had symptoms which included nauseous, very exhausted, shortness of breath and lethargic the evening of the second shot and ended up being transported by ambulance to the hospital. The patient experienced continued weakness, shortness of breath, drowsiness, lost weight, lower leg edema, shortness of breath where he cannot walk, swelling, still is dizzy, lack of appetite after discharge and ""have triggered his immune system; his immune system is now in one heck of a fight"" on an unknown date, Feb2021. The patient underwent lab tests and procedures which included D-Dimer test (fibrin degradation products): elevated on an unknown date from previous diagnosis of Covid back in Oct2020, was hospitalized for about a week and upon discharge he continued to feel fatigue with elevated D-dimer; fibrin degradation products: unknown results on 17Mar2021, investigation tests after hospitalization on an unknown date and all of his test results were normal. The clinical outcome of the events COVID-19, asthenia, somnolence, weight decreased, lower leg edema, lethargy, and immune system disorder was unknown; for pain, dizziness, swelling, decreased appetite, dyspnea and gait inability was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.""	No current illness for this event.	1158698-1	Unknown	2021/03
265	PFIZER\BIONTECH	Leukemia diagnosed several years ago that was back since the vaccination; Lungs filled with liquid; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, route of administration and therapy date unspecified, for COVID-19 immunization. Medical history included agent orange exposure, and leukemia that was diagnosed several years ago. The patient's concomitant medications were not reported. On an unspecified date, the patient's leukemia that was diagnosed several years ago had been back since the vaccination; and the patient's lungs were filled with liquid. The patient was in a care home. The outcome of the events was unknown.  Information about lot/batch number has been requested.	No current illness for this event.	1174027-1	Unknown	2021/04
266	PFIZER\BIONTECH	mild GI upset; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse and consumer reported that a 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021(Batch/Lot number was not reported) at the age of 67-years-old as single dose for covid-19 immunisation; bosutinib (BOSULIF), via an unspecified route of administration from 26Mar2021 (Batch/Lot number was not reported, expiration date: 31Dec2023) at 400 mg, once daily for chronic myeloid leukaemia. Medical history included acute sinusitis, allergic rhinitis, anemia, chronic myeloid leukemia, cough, depression, elevated white blood cell count, gastro-esophageal reflux disease, anxiety, osteoarthrosis, fatigue, pleural effusion, postanasal drip, allergies: sulfa, doxycycline, morphine, stadolol, vytorin. Concomitant medications included atorvastatin taken for an unspecified indication, start and stop date were not reported; furosemide taken for an unspecified indication, start and stop date were not reported; montelukast taken for an unspecified indication, start and stop date were not reported; escitalopram taken for an unspecified indication, start and stop date were not reported, dasatinib monohydrate (SPRYCEL) taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant. Patient recieved covid vaccination yesterday on 25Mar2021 and the patient experienced mild GI upset this morning on 26Mar2021. The action taken in response to the event for bosutinib was unknown. The outcome of the event GI upset was unknown.  No follow-up attempts are needed. No further information is expected.	No current illness for this event.	1174359-1	65-79 years	2021/04
267	PFIZER\BIONTECH	Fever/temperature was 99.6/ 99.4 /99.3; This is a spontaneous report from a contactable consumer. A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 2 via an unspecified route of administration on 25Mar2021 09:00 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. Medical history included heart valve replacement from 13Nov2019 to an unknown date (His heart operation was 13Nov2019 it has been 16 months that he has been inactive), chronic myeloid leukaemia from 2018 to an unknown date, accumulating fluid around the lung sack from an unknown date and unknown if ongoing aortic stenosis (from an unknown date and unknown if ongoing (They changed the heart valve because he had aortal stenosis), heart murmur from an unknown date and unknown if ongoing (He went in to see his general practitioner and a woman there said he had a heart murmur) cough from an unknown date and unknown if ongoing (Caller states he has a little cough. He quit smoking several years ago and has been coughing ever since. The cough was prior to COVID-19 vaccines) fell from Nov2020 to an unknown date (Caller fell the first week of Nov2020 and that is how long the process has taken. He has been in pain for months. Caller clarified that his hospitalizations and fall were prior to getting the vaccine). The patient previously took first dose of bnt162b2 for covid-19 immunisation and sprycel and experienced kidneys were failing. (Caller clarified that the hospitalization he had for 8 days was when he was on Sprycel and he was hospitalized because his kidneys were failing). Caller clarified that he has a fever, but he is not sure what it is because of the thermometer. Earlier today it was 99.6. It is now 2:24PM (State name) time, so it has been 5.5 hours since the vaccine on 25Mar2021. His temperature was 99.6 then 99.4 then 99.3. Frankly he doesn't trust it. He had positive experience both times he got the COVID Vaccine. The patient underwent lab tests and procedures which included body temperature: 99.6 on 25Mar2021 body temperature: 99.4 on 25Mar2021 body temperature: 99.3 on 25Mar2021 white blood cell count: unknown results on (When he went to the doctor to get checked he had unusual white blood cells running). The outcome of the event was reported as unknown.   No follow up attempts are needed. No further information is expected.	No current illness for this event.	1183941-1	65-79 years	2021/04
268	PFIZER\BIONTECH	leukemia; A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS   This is a report from an interventional study source sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. The subject was in open-label phase of the study when the event occurred.   A 63-year-old male subject received blinded study vaccine (BNT162B2;PLACEBO) first dose on 29Aug2020 at 12:46 and second dose on 19Sep2020 at 09:12; the subject was unblinded to provide the opportunity of receiving COVID-19 vaccine per protocol and found to have received placebo. Then the subject received in open-label phase study vaccine BNT162B2, third dose on 11Jan2021 at 16:25 (Lot # P220395-020L) and fourth dose on 01Feb2021 at 16:06 (Lot# P220395-0068L), all via intramuscular (IM) route in left arm as single doses for COVID-19 immunization.  Ongoing medical history included diabetes mellitus type 2 from 1990, hypercholesterolemia from 2016, obesity from 2000, hypertension from 2010, sleep apnea from 2011, osteoarthritis knees from 2005, gastro esophageal reflux disease from 2018, coronary artery disease from 26Feb2021, worsening of elevated troponin level to 55 from 10Mar2021, productive cough from 01Mar2021. Additional medical history included pneumonia  from 18Feb2021 to 01Mar2021, non-ST elevation myocardial infarction on 26Feb2021 (AER 2021286057), coronary spasm from 08Mar2021 to 12Mar2021 (AER 2021286096), coronary blood stasis from 08Mar2021 to 12Mar2021 (AER 2021286096), elevated troponin level from 26Feb2021 to 10Mar2021. Family medical history relevant to adverse event included father-heart disease, mother-cancer, maternal grandmother-cancer, mother-osteoarthritis.  Ongoing concomitant medications included dulaglutide (TRULICITY) for diabetes mellitus type 2 from 2017, pravastatin for hypercholesterolemia from 2016, lisinopril for hypertension from 03Oct2020, dexlansoprazole (DEXILANT) for gastro esophageal reflux disease from 2018, fluticasone for seasonal allergies from 2017, cyanocobalamin for nutritional supplement from 2019, acetylsalicylic acid (ASPIRIN) for cardiovascular prophylaxis from 2015, vitamin D3 for nutritional supplement from 01Jan2021 and multivitamin for nutritional supplement from 2017. The subject had no concomitant vaccines or prior vaccinations (within 4 weeks).  The subject was diagnosed with leukemia on 18Mar2021, which was considered an important medical event and required a physician office and a visit to the emergency room. Clinical course was as follows: complete blood count (CBC) panel on 12Mar2021 (hospital discharge date for AER 2021286096) included:  white blood cell count (WBC) was 6.1 thousand/ul; cellular percentages were neutrophils 18%, lymphocytes 55%, monocytes 2%, basophils 0%, eosinophils 0 %, blasts 25% (low); absolute cell counts were absolute neutrophils 1098 cells/ul, low, absolute lymphocytes 3355 cells/ul, absolute monocytes 122 cells/ul, low, absolute basophils 0 cells/ul, absolute eosinophils 0 cells/ul, absolute blasts 1525 cells/ul; red blood cell count (RBC) was 2.81 million/ul (low), hemoglobin was 9.2 g/dl (low), hematocrit was 27.5% (low), mean cell volume (MCV) was 97.9 fl, mean cell hemoglobin (MCH) was 32.7 pg, mean cell haemoglobin concentration (MCHC) was 33.5 g/dl, red cell distribution width (RDW) was 14.7 %, platelet count was 129 thousand/ul (low), and mean platelet volume (MPV) was 9.5 fl.  Iron studies on 12Mar2021 were iron, total was 82 mcg/dl (low), iron binding capacity was 226 mcg/dl, % saturation was 38 mcg /dl, ferritin was 1396  ng/ml (high), and glucose was 163 mg/dl (high). Subject was referred to Oncology and had two bone marrow tests performed on 15Mar2021 and 25Mar2021. The doctors were testing the type of leukemia and the treatment options. Subject was scheduled to be admitted at hospital during the first week of April for 28 days. The action taken in response to the event for blinded study vaccine and study vaccine (BNT162B2) was not applicable (reported as dose not changed by the investigator). The outcome of the event was not recovered.   The investigator considered there was a reasonable possibility that the event leukemia was related to study vaccine (BNT162B2), while unrelated to blinded study vaccine, concomitant drugs or clinical trial procedure.; Sender's Comments: The event ""Leukemia"" is unlisted in the Single Reference Safety Document (SRSD) of the Investigational Product therapy vaccine (BNT162B2).  The company considers there is not a reasonable possibility that the event, leukemia, is related to vaccine administration based on the known adverse event profile of the suspect product and on the absence of a plausible pathophysiological mechanism by which the vaccine would be expected to cause this event.  Pfizer's safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 15-MAR-2021 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Leukaemia. Review of the database for the PT Leukaemia had the following results: 0 serious clinical trial cases (0 of which were attributed to therapy) and 2 non clinical trial cases.  The impacts of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committee and Investigators, as appropriate.""	Coronary artery disease; Coronary spasm; Disorder circulatory system (coronary blood stasis); Gastroesophageal reflux disease; Hypercholesterolemia; Hypertension; Non ST segment elevation myocardial infarction; Obesity; Osteoarthritis knees; Pneumonia; Productive cough; Sleep apnea; Troponin increased (worsening of elevated troponin level to 55); Troponin increased (elevated troponin level); Type 2 diabetes mellitus	1191848-1	60-64 years	2021/04
269	PFIZER\BIONTECH	flu like symptoms; Fever/low grade fever at night; body aches; excessive sleeping; vaccine arm enlarged lymph nodes; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6200), via an unspecified route of administration in left arm on 18Feb2021 11:30 (68-years-old at the time of vaccination), as single dose for covid-19 immunization. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9263), via an unspecified route of administration in left arm on 28Jan2021 11:30, as single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered:Public Health Clinic Administration facility. Medical history included chronic lymphocytic leukaemia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 19Feb2021 at 11:30, the patient experienced flu like symptoms, fever/low grade fever at night, body aches, excessive sleeping and vaccine arm enlarged lymph nodes. Did the adverse event result in any of the following?: Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.	No current illness for this event.	1224061-1	65-79 years	2021/04
270	PFIZER\BIONTECH	throat tightness; axillary node lymphadenopathy; myalgia; fever/a high fever of 103; chest wall erythema; This is a spontaneous report from a contactable physician. A 63-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: ER8727) as SINGLE DOSE for covid-19 immunisation. Medical history included leukaemia, seasonal allergy, anaphylactic reaction, drug hypersensitivity. Concomitant medication(s) included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma from an unspecified start date and ongoing; azelastine hydrochloride, fluticasone propionate (DYMISTA) taken for hypersensitivity from an unspecified start date and ongoing; dasatinib monohydrate (SPRYCEL, NDC: 0003-0524-11) taken for chronic myeloid leukaemia from 2013 to an unspecified stop date; spironolactone (SPIRONOLACTONE) taken for fluid retention from 2017 to an unspecified stop date; mirabegron (MYRBETRIQ) taken for hypertonic bladder, start and stop date were not reported and unspecified medications for leukemia. The patient previously received Epipen for anaphylactic allergies to foods, drug, and environmental allergies. Caller was calling about the Pfizer BioNtech COVID vaccine. She has had a plethora side effects since her second dose 24Mar2021. It all started with chest wall erythema then it moved to axillary node lymphadenopathy the she got a high fever of 103 and then there was myalgia all across her torso, abdomen, and and upper back, she clarifies her trapezius area. She confirmed on 24Mar2021 the chest wall erythema began that afternoon, 24Mar2021. Axillary node lymphadenopathy began Thursday, she confirms 25Mar2021 ongoing improved. The fever began Wednesday, she confirms 24Mar2021 and it was still ongoing. Yesterday she woke up and it was 103 today it is a bit better, it is 101.2. She confirms today it seems to be improved a bit but yesterday she was taking hand fulls of Ibuprofen to try to get it down. The myalgia she noticed Thursday 25Mar2021 and it was ongoing, it was some what improved. She has environmental allergies. She had some throat tightness the day of the COVID vaccine that dissipated late that afternoon and that was for both doses. She carries an Epipen because she has food, drug, and environmental allergies. She has had anaphylactic allergies to foods. She clarified she was far from needing to use an Epipen with the her doses of the COVID vaccine, the throat tightness just dissipated. She does not think an Epipen would have helped a fever and body aches anyway. She said she takes Spironolactone for fluid retention from the Sprycel. She tried to look up to see if there was any interaction between the vaccine and Sprycel but she couldn't find any thing. Her husband was in the pharmaceutical industry as well and they have looked up available information of duration of side effects and they couldn't fine anything and she was just surprised that after 4 days of it she was still waking up with fever and still having myalgia. She was wondering if the agencies had reported or maybe they have not unmasked any data yet of duration of things reported that are listed. It just seemed extremely unusual. Caller reported fever after her second dose of the Pfizer BioNtech COVID 19 vaccine. She said yesterday she was taking hand fulls of Ibuprofen to try to get the fever down. Today the fever was a bit better but it was still ongoing. The outcome of the event fever, myalgia were not recovered, chest wall erythema was recovered on 27Mar2021, throat tightness was recovered on an unspecified date and axillary node lymphadenopathy was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained	No current illness for this event.	1224117-1	60-64 years	2021/04
271	PFIZER\BIONTECH	her left side was very weak; her left arm was sore for a while which radiated to shoulder; her left arm was sore for a while which radiated to shoulder; back pains; her ears hurt on left side; hearing ringing and a loud noise which hurts the brain; hearing ringing and a loud noise which hurts the brain; hearing ringing and a loud noise which hurts the brain; heavy sweating around the neck; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 30Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included thyroid (disorder), had 2 bad strokes a few years ago, heart attack on the left side, chronic pain, bone issues, leukemia in the bone, TIA, and miniature strokes. Concomitant medication included warfarin sodium (COUMADIN). The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 for COVID-19 immunization in her right arm and it hurt a little bit. The patient also experienced coumadin level increased; she takes coumadin regularly and measured her coumadin level to be at 1.6 after getting the 1st dose. 2 weeks after, she mentioned that her level was 3 point something which was too high. The patient received her 2nd dose of the Pfizer COVID19 vaccine on 30Mar2021 on her left arm. She mentioned that her left arm was sore for a while which radiated to shoulder on 2021. It was hurting real the first night, but she mentioned that she was going to be fine and take Tylenol. She mentioned that her left arm was her dominant arm. She also had some back pains and that her ears hurt on left side and she has been hearing ringing and a loud noise which hurts the brain on 2021. She also mentioned that her left side was very weak on 2021. She takes coumadin regularly and measured her coumadin level to be at 1.6 after getting the 1st dose. 2 weeks after, she mentioned that her level was 3 point something which was too high. Upon receiving her 2nd dose, it went down to 2.4. She specifically mentioned that she did not bleed from the injection site. She also had heavy sweating around the neck last night (2021) to the point that she woke up to ""a pool of her own sweat"". She mentioned that she had the sweating in the winter times too and maybe associated with her thyroid. She is asking if these have been reported with the vaccine and if coumadin or blood thinners may interact with it. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.""	No current illness for this event.	1224492-1	Unknown	2021/04
272	PFIZER\BIONTECH	a sore arm; This is a spontaneous report received from a contactable consumer. This 75-year-old male contactable consumer (patient) reported for himself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration, administered in Arm Left on 03Feb2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included chronic lymphocytic leukaemia Stage 0 No active treatment from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. On 03Mar2021 12:00, he stated the only reaction he had was a sore arm. His wife has had an antibody test which came back positive and he has had two antibody tests which came back negative. He has CLL, a type of Chronic Leukemia, that effects his immune system. He wants more information on antibody testing after receiving the Pfizer COVID-19 vaccine and whether or not he was protected. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.	No current illness for this event.	1224498-1	65-79 years	2021/04
273	PFIZER\BIONTECH	developed disseminated HZV infection 15 days post his first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a non-contactable physician. A 63-year-old male patient received the first dose of bnt162b2 (BNT162B2, Lot number Unknown), via an unspecified route of administration on an unspecified date as a single for COVID-19 immunization. Medical history included hairy cell leukaemia from 2006 to an unknown date Hairy Cell leukemia in 2006  remission since 2016. The patient's concomitant medications were not reported. The patient developed disseminated varicella zoster virus infection 15 days post his first dose of the Pfizer COVID-19 vaccine on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: While patient risk factors may likely predispose patient to reported event, a possible contributory effect of suspect BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.	No current illness for this event.	1224676-1	Unknown	2021/04
274	PFIZER\BIONTECH	AML, acute myeloid leukemia	None	1225518-1	80+ years	2021/04
275	PFIZER\BIONTECH	so the vaccine did not work; His Chronic Lymphocytic Leukemia did not work well with the vaccine; His Chronic Lymphocytic Leukemia did not work well with the vaccine; This is a spontaneous report received from a Pfizer Sponsored Program from a contactable consumer (patient). This male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the 1st dose (lot number: EL1284) on 13Jan2021, the 2nd dose (lot number: EL9263) on 03Feb2021; both via an unspecified route of administration at single dose for COVID-19 immunization. Medical history included immunosuppressed and chronic lymphocytic leukemia. Concomitant medications were unknown. The patient said his doctor found out that his chronic lymphocytic leukemia (CLL) did not work well with the vaccine. His physician took a blood test (for CLL) the other day and said that there was a problem with his CLL results and the vaccines (like interference). The patient stated he was seeing his HCP yesterday or the day before yesterday, they took blood work and told him his CLL did not work and the Pfizer vaccine did not work good on him. The patient was asking what can be done; stated they took his blood work again and the CLL did not work so the vaccine did not work; no further clarifying details provided by the caller. He wanted to know what he should do about this. Response included ""CONS-use in immunosuppressed patients (v3.0)"" and ""CONS-what is the pfizer-biontech covid-19 vaccine (v3.0)."" The patient wanted to know if he can stop wearing masks whenever he's around people who had already been vaccinated with both doses of the Pfizer-BioNTech Covid-19 Vaccine. He also wanted to know if he can still be a carrier of the virus. Response was ""CONS - post-vaccination precautions - wearing a mask and social distancing after receiving the vaccine (v5.0)."" Outcome of the events was unknown.""	No current illness for this event.	1227875-1	Unknown	2021/04
276	PFIZER\BIONTECH	has Leukemia CLL and she got both doses of Covid vaccine; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), first and second dose, via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that the patient has Leukemia CLL and she got both doses of covid vaccine on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.	No current illness for this event.	1235785-1	Unknown	2021/04
277	PFIZER\BIONTECH	Nose bleeds/ worsened; Nose bleeds/ worsened; This is a spontaneous report from a contactable consumer (the patient). A 79-year-old male patient received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 24Feb2021 (lot number EN6198) in the right arm, and on 20Mar2021 (lot number EP7534) (unsure which arm), respectively, both via an unspecified route of administration (at the age of 79-years-old), as a single dose for COVID-19 immunization; and apixaban (ELIQUIS) film-coated tablet, oral from an unspecified date (lot number 1743875, expiration date Feb2023), at 5 mg, twice a day as blood thinner. The patient's medical history included: chronic lymphoma leukemia from 2006- he is presently MRD negative, cardiomyopathy, alcohol ablation- where they go in through the groin and shoot alcohol to shrink the size of the heart to kill the fat around the heart. There were no concomitant medications. In Feb2021, after the first dose, the patient experienced nose bleeds. The patient never had nose bleeds before until after getting the first dose and was having more since getting the second dose. He has had two in one day. He was asking if the vaccine causes nose bleeds with taking a blood thinner. The nose bleeds have been more frequent. The nose bleeds were reported as worsened. The nose bleeds did not require an emergency room or physician office visit. The action taken in response to nose bleeds/ worsened for apixaban was unknown. The outcome of nose bleeds/ worsened was not recovered.  Follow-up (26Mar2021): This is a follow up spontaneous report from a contactable consumer based on information received by Pfizer from US-BRISTOL-MYERS SQUIBB (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-031555), license party for apixaban (ELIQUIS).  This case was received via Pfizer Inc (Reference number: 2021339514) on 26-Mar-2021 and was forwarded to BMS on 30-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose Bleeds) in 79-year-old male patient who received apixaban (Eliquis) film-coated tablet (batch no. 1743875) for an unknown indication. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19 immunisation. The patient's past medical history included Chronic lymphoid leukemia (He is presently MRD negative) in 2006, Cardiomyopathy and Alcohol septal ablation (where they go in through the groin and shoot alcohol to shrink the size of the heart to kill the fat around the heart). On an unknown date, the patient started Eliquis (batch no. 1743875) (Oral), 5 milligram twice a day. On 24-Feb-2021, the patient started Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced EPISTAXIS (Nose Bleeds). The action taken with Eliquis(Oral) was unknown. At the time of the report, EPISTAXIS did not resolve. For Eliquis(Oral), the reporter did not provide any causality assessments. The reporter stated that he never had nose bleeds before until after getting the first dose and was having more since getting the second dose. He has had two in one day. He was asking if the vaccine caused nose bleeds with taking a blood thinner. The nose bleeds have been more frequent. He received he first dose on 24-Feb-2021 and the second dose on 20-Mar-2021. Event nose bleeds did not require a visit to emergency room or physician office. Relevant Tests: none.	No current illness for this event.	1245596-1	65-79 years	2021/04
278	PFIZER\BIONTECH	Fever & chills; enlarged lymph node under right arm; Fever & chills; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 17Feb2021 12:00 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL). Concomitant medication(s) included vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 27Jan2021 13:45 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies. Since 18Feb2021 01:45, the patient experienced Fever & chills, enlarged lymph node under right arm. No treatment received for AE. Outcome of the events was recovering.	No current illness for this event.	1249992-1	65-79 years	2021/04
279	PFIZER\BIONTECH	injection site pain; CHILLS; tired; dizzy; elev BP and pulse; elev BP and pulse; This is a spontaneous case from a contactable consumer. A 66-Years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered on left arm on 18-FEB-2021 10:30 at the age of 66 years old as single dose for COVID-19 immunisation. Historical vaccine included first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered at Left arm on 28Jan2021 01:45 PM. The patient medical history included multiple sclerosis and chronic lymphocytic leukaemia. The patient past drug events included oxybutynin, trospium chloride and myrbetriq. The patient was allergies to sulfa, nickel on skin and bandage adhesive. Concomitant medications were not reported. On 18Feb2021at 18:00, the patient had experienced vaccination site pain, chills, tired, dizzy, elevated BP and pulse. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has not recovered from the events.  Information on lot number/batch number has been requested.	No current illness for this event.	1250014-1	65-79 years	2021/04
280	PFIZER\BIONTECH	rash; This is a spontaneous report from a contactable consumer. A 79-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 (Batch/Lot Number: el9269) as SINGLE DOSE for covid-19 immunization. The medical history of patient included vascular disease, chronic lymphocytic leukemia, squamous cell. The concomitant medications included Atorvastatin, Metoprolol, multivitamin, low dose As. The patient previously took amoxicillin and experienced drug hypersensitivity, doxycycline and experienced drug hypersensitivity. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/LOT no el3294) dose 1 on 20Jan2021 at 10:30 via an unknown route of administration in left arm as single dose for COVID-19 immunisation. On 13Feb2021, the patient had rash that appeared about 4 inches in diameter and continued to enlarge around arm above elbow and on the inside of arm down to watch band through 20Feb2021. Patient did not receive any treatment. Patient did not have covid prior vaccination. Patient did not have covid tested post vaccination. The outcome of the event was recovered on 24Feb2021.	No current illness for this event.	1254144-1	65-79 years	2021/04
281	PFIZER\BIONTECH	heart was fluttering and beating out of her chest; Elevated heart rate/The highest was 130; she felt her heart racing; Heart rate goes up and down; could not do anything and was laying in bed or on the couch; white blood cell count is higher than it should be; has allergies to medications but not what was in the Pfizer shot. She adds that maybe she had a reaction to the chemicals in there.; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EN6206 and expiry date: was not provided), via an unspecified route of administration, in arm left, on 10Mar2021 at 03:30 PM, as a single dose for COVID-19 immunization, at hospital. The patient was not pregnant at the time of vaccination. The patient was tested for COVID-19, before the vaccination, however, results not provided. The patient has not been tested for COVID-19, after the vaccination. Patient's medical history included breast cancer survivor, chronic lymphatic leukemia. Patient had known allergies with penicillin and sulfa. Concomitant medications included calcium, colecalciferol (D3), macrogol 3350 (MIRALAX), multi vitamin, and ibuprofen (ADVIL DUAL). The patient previously took ciprofloxacin (CIPRO) and morphine: and had allergies with both drugs. The patient reported that on 11Mar2021, her heart was fluttering and beating it out of her chest with elevated heart rate which goes up and down. She also felt her heart was racing. It was very erratic. The highest heart rate was 130 (non-sustained). It was started since morning after the vaccination and was still happening now and wanted to know that it was a normal side effect. She had a cardiac work up and couldn't find anything however, everything was normal. Her heart rate went up to 130, 140, 150 and went to 80. This was happened over a period of 5 or 6 days. She felt like she could not do anything and was lying in bed or on the couch for three days. Her white blood cell count was higher that it should be. She went to her regular doctor who did the EKG, however, results not provided. Further, she went to a Cardiologist and they did another EKG and wore a monitor for a week and did echocardiogram and blood work all results were normal. She was wondering, if this could possibly be a side effect from the vaccine because it did occur in the morning after she got vaccinated. She also reported that she had allergies to medications but not what was in the vaccine and that maybe she had a reaction to the chemicals in the vaccine. She was supposed to get the second shot of vaccine which was scheduled on 31Mar2021 and had concerned about getting the second shot because she had some allergies and now this happened. She was very frightening and thought that she was going to die. It was very scary for her. The product complaint was not reported. The patient did not receive any treatment for the event. Outcome of the event Allergy to chemicals was unknown and for all other events it was recovered on an unknown date in Mar2021.  No follow-up attempts possible. No further information expected.	No current illness for this event.	1254330-1	60-64 years	2021/04
282	PFIZER\BIONTECH	After the second shot, my father began coughing worse and it appeared his COPD exacerbated, as well as progression in memory loss and confusion.  His oxygen levels decreased and his blood work showed low platelets, so he was admitted to hospital on March22-23.  Discharged with recommendations to see hematologist.  Bone marrow biopsy indicated a very rare form of leukemia (Hairy Cell ).  Cancer likely not a cause of vaccine of course, but suspected low blood platelets and exacerbation of COPD?	COPD/age related memory loss	1254982-1	80+ years	2021/04
283	PFIZER\BIONTECH	Within 3 days I was experiencing extreme night sweats, lack of energy, inability to wake up, occasional fever, exhaustion. After about 3 weeks with no improvement I went to urgent care to get a COVID test. The results were negative however the staff there urged me to go to the emergency room at Hospital based on the symptoms I had described. I had bloodwork done and with some abnormalities was sent home with an appointment to follow up with my general physician. By the time I arrived home there was a message from the hospital saying I had leukemia and requested I come back to the hospital for admittance and further testing.  I have since been diagnosed with Acute Lymphonblastic Leukemia, had a pic line put in, ekgs, brain scans, lumbar punctures, marrow testing, platelet and blood transfusions, and my first round of chemo with a 12 day hospital stay. My oncologist urged that I report this as I had bloodwork done in late January with absolutely no abnormalities and as I don?t work and stay home mostly the only new exposure to my system was the Pfizer vaccine.  Ahead of me I have countless hospital visits for bloodwork, chemotherapy, blood and platelet transfusions and so many more unknowns.	N/a	1256859-1	60-64 years	2021/04
284	PFIZER\BIONTECH	not showing any immunity; he tested negative for antibodies/not showing any immunity; His arm was a little sore and he was a little tired; His arm was a little sore and he was a little tired; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 73-years-old male patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection; Lot Number: EL9262 and expiry date was not provided), via an unspecified route of administration, in left upper arm muscle on 05Feb2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history included ongoing blood pressure abnormal, ongoing Gout, CLL ((Chronic lymphocytic leukaemia), It is a blood disorder. He is not on medication for it and is asymptomatic. He has been diagnosed about four or five years), ongoing thyroid disorder and He had a nodule years ago and it was removed. The concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid disorder, allopurinol taken for gout, atorvastatin, amlodipine besilate, acetylsalicylic acid (BABY ASPIRIN), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12), colecalciferol (VITAMIN D), finasteride, irbesartan taken for blood pressure abnormal and tamsulosin. Historical vaccine included first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection; Lot Number: EL1284 and expiry date was not provided) via an unspecified route of administration, in left upper arm muscle on 15Jan2021 as SINGLE DOSE for Covid-19 Immunization. It was reported that the patient had both doses of Pfizer vaccine, tomorrow would be four weeks since his second dose. The patient reported that his arm was a little sore and he was a little tired for a day or two. Patient had the antibody test on 01Mar2021 (Monday), got the results on 03Mar2021 as negative and reported that it was not showing any immunity. The patient had no vaccines within 4 weeks of getting his COVID19 Vaccine. The outcome of the events reported as unknown.  Follow-up attempts are completed. No further information is expected.	Blood pressure abnormal (Verbatim: Blood pressure); Gout (Verbatim: Gout); Thyroid disorder	1261656-1	65-79 years	2021/04
285	PFIZER\BIONTECH	This is a spontaneous report from a contactable consumer (patient). This 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581), via an unknown route on 09Feb2021 at 13:00 (at the age of 75-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included: For allergies the patient takes Loratadine unknown dosage started unknown date, did not think he took Loratadine on 09Feb2021 but he can take it daily if he wants to. The patient injects self every 2 weeks with Dupilumab (Dupixent)started around over a year ago for Chronic dermatitis-further dosage details unknown. The patient had flu shot unknown date, maybe 6-8 months ago. Family medical history included: The patient wife died of Lupus, his dad had heart problems and emphysema from smoking. His mother had leukemia. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unknown route on 19Jan2021 at 12:00 (at the age of 75-years-old) at single dose on the right arm. Concomitant medications was not provided. After the vaccination of first dose (19Jan2021), the patient had sore arm to lay on for that night. After second dose of vaccination (09Feb2021), the patient was laying in bed around. On 10Feb2021, (at 00:30-01:00), the patient had chills, shaking from being cold and body temperature was above normal. His bedroom was warm, like 80 degrees Fahrenheit. Body temperature above normal. Temperature recorded during this event include 100.3 degrees Fahrenheit about a half hour ago. His body temperature was normally like 97.8 degrees Fahrenheit this time of the day. Right now his body temperature was 100.4 degrees Fahrenheit. His body temperature was never high like that. It was rare if he had a day with a 99 degrees Fahrenheit body temperature. Chills and shaking from being cold lasted about a half an hour. The patient had some warm clothes on and turned the heat up a little bit. He recovered with possible lasting effect of being tired. But the patient always feels tired in the morning so not sure if it was from him not sleeping well last night. Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s) was none. Adverse event following prior vaccinations was none. Physician office or emergency room visit was not required for any event. Outcome of the events While he was laying in bed around 00:30-01:00 10Feb2021 he got chills, shaking from being cold and cold was recovered with sequel. Outcome of the remaining events was unknown. Follow-up attempts are completed. No further information is expected.	Allergy (Loratadine for allergies); Dermatitis (Treated with Dupixent)	1261661-1	65-79 years	2021/04
286	PFIZER\BIONTECH	Bells Palsy; This is a spontaneous report from a contactable consumer reporting for husband. A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0153/expiration date: 31Jul2021), via an unspecified route of administration, on 11Apr2021 (at the age of 58 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EM8727/expiration date: 31Jul2021), via an unspecified route of administration, on 21Mar2021 (at the age of 58 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included ongoing hypertension, when he was about 45, probably 10 years and was recovering from leukemia onset 2 years ago, in 2019 and he has been recovering from leukemia since about 2020; the patient had an ongoing history of being a little overweight, with onset unknown other than over 10 years ago. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) 10mg tablet taken by mouth once daily for hypertension. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021, late afternoon the patient experienced swelling in his face, couldn't blink, drooping and was diagnosed with Bells Palsy which required an emergency room visit. He was not admitted to the hospital for this event, was kept under observation only in the emergency room on 12Apr2021. He was given some medication and then discharged. Bell's Palsy affected his right side of his face. The outcome was improved, the pain was a little less; but he still does not have, nothing works on the right side of his face. His right eye does not blink, eyebrow does not move, and he still can't speak very good. Treatment was received for the event. The outcome of the events Bells Palsy was recovering. Since the vaccination, the patient had not been tested for COVID-19.	Hypertension (when he was about 45, probably 10 years); Overweight (Onset unknown other than over 10 years ago.)	1261791-1	50-59 years	2021/04
287	PFIZER\BIONTECH	developed rash to the chest, head and all over the body/Rash looked like measles; Scalp was extremely itchy; dermal hypersensitivity reaction; This is spontaneous stimulated report received from a contactable health care professional. A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in right arm on 04Mar2021 (Lot Number: EN2605) as single dose for covid-19 immunisation; hydrocodone bitartrate, paracetamol (NORCO), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included gastrooesophageal reflux disease (GERD), hyperlipidaemia, chronic lymphocytic leukaemia (CLL), Degenerative joint disease (DJD). No allergies to medications, food, or other products. Concomitnat medications the patient received within 2 weeks of vaccination including amlodipine, celebrex, lipitor, omeprazole. The patient previously took first dose BNT162B2 on 11Feb2021 for covid-19 immunisation via intramuscular at left arm, developed rash on chest bilaterally on 20Feb2021. Went to dermatology, doctor gave triamcinolone for treatment. The most recent COVID-19 vaccine was administered at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Few days after second dose patient developed rash to the chest, head and all over the body. He went back to dermatology and had biopsy near his hair line. Scalp was extremely itchy, so given clobetasol. Rash looked like measles. Not on face or hands. Saw derm again on 18Mar2021, received cortisone injection with second one on 25Mar2021- first shot-4 hours of relief from itching, rash lessened temporarily and then new areas started developing. BX results (as reported): some of the features raise possibility of angiolyphoid hyperplasia with eosinophilia but favors dermal hypersensitivity reaction. No swollen lymph nodes that patient notes. Patient is extremely itchy. Taking benadryl and taking allegra during the day. Only change recently has been switching norco from 7.5/325 three times a day to 5/325 four times a day.  Wonders if the increased APAP dose caused the rash. Events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Treatment received for adverse events included pepcid, benadryl, clobesatol, allegra, Zyrtec. The event outcome for events was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events measles-like rash, itchiness, and dermal hypersensitivity with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.	No current illness for this event.	1266017-1	65-79 years	2021/04
288	PFIZER\BIONTECH	1 1/2 weeks post dose 1, 4/13, I started to have lo grade fever, headache, muscle weakness and body aches. On 4/15 I broke out in a red splotchy rash all over my arms, then my front torso and back torso. I had blood work on 4/17 and my kidney and liver numbers were very elevated, my platelets were very low, and my red blood cells were described as ""immature."" on 4/19 I repeated the labs and they were worse. My internist referred me stat to a hematology oncologist. On 4/20 I had a series of discreet tests on my blood, and also a bone marrow biopsy. The concern was acute onset leukemia. My tests came back days later ruling out blood cancer, and the doctor says the best guess is an extreme antibody reaction to the vaccine.  My rash began to abate around 4/23. It is now Friday 4/30. I have been unable to work, and my symptoms are continued muscle pain and weakness. I still have some lo grade fever, headaches and dry sinuses. I have never felt sick like this.""	none	1273543-1	60-64 years	2021/04
289	PFIZER\BIONTECH	This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have antibodies after getting tested. Has leukaemia on an unspecified date. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: negative on an unspecified date.  The outcome of the event was unknown. The event was considered as serious (medically significant).  Information on the lot/batch number has been requested.	No current illness for this event.	1279156-1	Unknown	2021/04
290	PFIZER\BIONTECH	woozy, about to pass out/like you are going to pass out; heavy breathing/breathing was heavy, voice was deep, like she really had to work to breathe; racing heart/heart was racing; rash/ rash was under the skin/ it started in the thighs and spread down her legs; vascular rash/ rash was under the skin/ it started in the thighs and spread down her legs/ it seems like a vascular reaction; pain at the injection site./super painful injection site; felt really really really poor; voice was deep; heavy chest, chest pain; heavy chest, chest pain; feeling woozy/woozy, about to pass out; This is a spontaneous report received from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8737), administered in left arm on 01Apr2021 01:15 PM (at the age of 36-year-old) at single dose for so she could be protected from COVID (as reported). It was reported that vaccine was not administered at military facility and vaccination facility type was hospital (reported as patient drove up to vaccine clinic). The patient's medical history included acute lymphocytic leukemia from 1992 to 1996 and not ongoing (she was immunocompromised when she was young, she was a cancer survivor). No family medical history relevant to events was reported. The patient declined being sick at the time of vaccination. No patient's concomitant medications were reported. No prior vaccinations reported within four weeks. No additional vaccines were administered on same date of the Pfizer suspect. The patient previously took gentamycin, amoxicillin and flu shot, culture specific to the flu (as reported), and she experienced allergy with all three on 1996. Patient said that she was immunocompromised when she was young, she was a cancer survivor. She said that right after remission she developed a gentamycin allergy and, because of the gentamycin and amoxicillin allergy she was allergic to the flu shot, not the flu but the egg culture, because the egg culture can be that reaction. Patient also said that she had a reaction to a flu shot back in 1996 or something, it was the same rash that was with the COVID vaccine. It was reported that patient had her first Pfizer Covid vaccine dose on 01Apr2021. She reported side effects of heavy breathing, racing heart, feeling woozy, rash, and pain at the injection site. It was reported that she would like more information and she wanted to know if she should get the second dose of the vaccine. Patient had both an event to report and a question. She said she had done application, the first vaccine was 2 weeks before the present report and she was not supposed to get the second until this Thursday (19Apr2021), she needed to look at a calendar. She said 01Apr2021 was her first vaccine and that she did already report her events. She said she had a bad reaction that borderline sent her to the emergency room but she instead took a BENADRYL and she laid down and then felt really really really poor the next 5 days. She said she had a terrible reaction, she didn't feel like her throat was shut, her breathing was heavy, her voice was deep, her heart was racing, like she really had to work to breathe, not like losing her airway passage, just that she had to work to breathe, she had a heavy chest, chest pain, a racing heart. She said she could best correlate it to how feels like low blood sugar, like you are going to pass out. It was also reported that patient experienced woozy, about to pass out. She said she ended up what she'd call a vascular rash. She said it started in the thighs and spread down her legs. She said it was not a rash at the injection site, the rash was under the skin rather than a topical rash. She said she had a photo of it, that it seems like a vascular reaction. She would like to file a report with us because she said she felt like she did not get anything out, she had logged what happened to them and there was no correlation, no confirmation. She said she could send the photo to them. She said she was scared to get second vaccine, she wonders if she should do her due diligence to do second dose, or if she should skip it. She said there was no protocol in place, she had a telemedicine call with her doctor, there was no $200 fee due, her physician said it sounds like patient had more than a normal reaction. She said there were other things that are scary, her doctor told her she should speak to an allergist, but she said it would cost her like $600. She said she didn't feel good on immediate injection, she felt like she probably shouldn't be driving her car. She looked for her notes then she said her only normal reaction was a super painful injection site but not a rash. She said the vascular rash subsided with the use of BENADRYL. She said she could not afford an allergist to figure out what's going on. She asked why someone as small as her would get the same dose as a 200 pound man and why the doses of the vaccine were not specific to size or weight based. She also asked if based on symptoms will someone in the medical Information department advised her not to get the second dose. Events onset date were reported as 01Apr2021. The case was reported as non-serious by the consumer. No events required emergency room visit. She confirmed that she did have a telehealth meeting with her general practitioner (also reported as no events required physician office visit), she said she talked to them on the phone. No investigations assessment and relevant tests were reported. The outcome of events was resolved on 02Apr2021 for ""rash/ rash was under the skin/ it started in the thighs and spread down her legs"" and ""vascular rash/ rash was under the skin/ it started in the thighs and spread down her legs/ it seems like a vascular reaction"", resolved on 08Apr2021 for ""heavy breathing/breathing was heavy, voice was deep, like she really had to work to breathe"" and ""voice was deep"", and resolved on 05Apr2021 for all other events.""	No current illness for this event.	1284768-1	30-39 years	2021/05
291	PFIZER\BIONTECH	Deafness right ear; Urinary tract infection; Feeling bad; Weakness; This is a solicited report based on the information received by Pfizer.  A 85-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; ibrutinib (IMBRUVICA), oral from 02Jun2015 (Batch/Lot number was not reported) to an unspecified date, at 140 mg, 3x/day [(140 mg, 3 in 1 D)] for chronic lymphocytic leukaemia; ibrutinib (IMBRUVICA), oral from an unspecified date (Batch/Lot number was not reported) and ongoing, at 420 mg, 1x/day [420 mg (420 mg, 1 in 1 D)] for Chronic Lymphocytic Leuk of B-Cell Type Not Achieve Remis The patient had no known medical history    The patient's concomitant medications were not reported.  The patient experienced deafness right ear, urinary tract infection, feeling bad and  weakness. All events involved hospitalization and were medically significant. The patient's hospitalization was prolonged as a result of deafness right ear, urinary tract infection, feeling bad,  weakness. The action taken in response to the event(s) for ibrutinib was permanently withdrawn on an unspecified date , for ibrutinib was dose not changed. The clinical outcome of the events was recovering.  Solicited report by a consumer of an elderly male with events of couldn't hear from right ear and urinary tract infection and non-serious feel crummy and weakened with Imbruvica (Ibrutinib) and Imbruvica (Ibrutinib). There was no reported medical history.  On unknown dates, the patient experienced couldn't hear from right ear, urinary tract infection, feel crummy and weakened. Covid-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown, expiration date unknown. Patient was in hospital for a week and had lots of tests. And came out to being urinary tract infection that made him feel crummy and was weakened. Patient also reported that couldn't hear from right ear it could be from Pfizer vaccine. Which was finished a month ago. And never had much trouble with Imbruvica.  Causality for Imbruvica (Ibrutinib) The reporter's causality for the event(s) of couldn't hear from right ear, urinary tract infection, feel crummy and weakened was not provided. Company's opinion is that there is no reasonable possibility that the event of couldn't hear from right ear is related to Imbruvica (Ibrutinib). Company's opinion is that there is a reasonable possibility that the events of Urinary Tract Infection, feel crummy and weakened are related to Imbruvica (Ibrutinib).  Causality for Imbruvica (Ibrutinib) The reporter's causality for the event(s) of couldn't hear from right ear, urinary tract infection, feel crummy and weakened was not provided. Company's opinion is that there is no reasonable possibility that the event of couldn't hear from right ear is related to Imbruvica (Ibrutinib). Company's opinion is that there is a reasonable possibility that the events of Urinary Tract Infection, feel crummy and weakened are related to Imbruvica (Ibrutinib).    Suspect Drug (s):  Seq.No . : 1 Drug: Imbruvica (capsule) (Ibrutinib), Unknown Daily dose: 420 mg (140 mg, 3 in 1 D) Route of Admin:  Oral Therapy dates/Duration: 02Jun2015-Discontinued Indications for Use: Chronic Lymphocytic Leuk of B-Cell Type Not Achieve Remis  Causality Deafness right ear (Deafness unilateral)  Action(s) taken with drug: Drug discontinued Causalis per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): No reasonable possibility Dechallenge:  Unk Urinary Tract infection (Urinary Tract infection) Action(s) taken with drug:  Drug discontinued Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge:  Unk Feeling bad (Feeling abnormal) Action(s) taken with drug:  Drug discontinued Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge: Unk Weakness (Asthenia)  Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge:  Unk  Seq No.: 2 Drug: Imbruvica (Tablet) (Ibrutinib) Daily dose:  420 mg (420 mg, 1 in 1 D) Route of Admin:  Oral Therapy dates/Duration: Unk-Ongoing  indications for Use: Chronic Lymphocytic Leuk of B-Cell Type Not Achieve Remis  Causality Deafness right ear (Deafness unilateral)  Action(s) taken with drug: Dose not changed Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): No reasonable possibility Dechallenge:  N/A Urinary Tract infection (Urinary Tract infection) Action(s) taken with drug:  Dose not changed Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge:  N/A Feeling bad (Feeling abnormal) Action(s) taken with drug:  Dose not changed Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge: N/A Weakness (Asthenia)  Action(s) taken with drug: Dose not changed Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge: N/A  Seq No.: 3 Drug: COVID-19 Vaccine (COVID-19 Vaccine), Unknown Daily dose:  Pfizer Vaccine Route of Admin:  Intra-muscular Indications for Use: COVID-19 Vaccination  Causality Deafness right ear (Deafness unilateral)  Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine):  Reasonable possibility Dechallenge:  N/A Urinary Tract infection (Urinary Tract infection) Action(s) taken with drug:  Unknown Causality as per reporter (Drug/Vaccine):  Not Reported Dechallenge:  N/A Feeling bad (Feeling abnormal) Action(s) taken with drug:  Unknown Causality as per reporter (Drug/Vaccine):  Not Reported Dechallenge: N/A Weakness (Asthenia)  Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  The reporter assessment of the causal relationship of the events UTI, Feeling bad and Weakness  with the suspect product BNT162B2 was not provided at the time of this report.  Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information, the reported  events deafness right ear, urinary tract infection, feeling bad and  weakness are attributed to underlying or intercurrent medical conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.	No current illness for this event.	1288422-1	Unknown	2021/05
292	PFIZER\BIONTECH	Nausea; 20 hrs after second shot severe shaking chills; fever 103F; chest burning; severe headache; severe weakness; This is a spontaneous report from a contactable consumer (patient). A 63-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262, Expiry date: unknown) via unspecified route of administration on right arm on 26Jan2021 as single dose for COVID-19 immunization. The patient medical history includes chronic lymphocytic leukemia, hypertension, type 2 diabetes, metastatic thyroid cancer, pulmonary metastases and allergic to Keflex and clindamycin. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1263) in right arm on 07Jan2021 15:00 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. On 27Jan2021 at 03:00, 20 hours after second shot, the patient experienced severe shaking chills, fever 103F, chest burning, severe headache, severe weakness and nausea. The patient did not receive any treatment for the events. The outcome of events was recovering.	No current illness for this event.	1290792-1	60-64 years	2021/05
293	PFIZER\BIONTECH	sore arm, from the injection, for only 1-2 days""; left arm discomfort; shoulder pain; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received bnt162b2 (PFIZER; Solution for injection; Lot number: EL3248) dose 1 via an unspecified route of administration, administered in left arm on 24Jan2021 as single dose for COVID-19 immunization. The patient's medical history included Chronic lymphocytic leukemia patient since Jul2015 and disrupt GI. Concomitant medications included ibrutinib taken for chronic lymphocytic leukaemia, meloxicam for arthralgia, flecainide taken for arrhythmia, aciclovir taken for antiviral treatment, guaifenesin, sulfamethoxazole, trimethoprim. The patient had a sore arm, from the injection, for only 1-2 days and was also taking meloxicam daily at the time. He then developed some ""GI problems, due to the possible side effects of the meloxicam, and PCP told him to stop taking this medication. The patient stated that on day 8 the soreness reappeared and became worse each day, then on day 10 took a meloxicam and the arm pain was better. The patient stated that he can no longer take the meloxicam and he still had moderately sore. Upon follow up received on 05Feb2021, His oncologist recommended him to get it. 12 days after he got the vaccine his side effect came back. He got it in his left arm. He had left arm discomfort for a couple of days. The discomfort disappeared. He was also taking Meloxicam 7.5mg because he needs his hip replaced. It started to disrupt his GI, so he discontinued it. After he discontinued the Meloxicam, the arm soreness came back. He believes the Meloxicam was masking the shoulder soreness. He discontinued the Meloxicam, and 12 days later after the vaccine, his shoulder pain came back. He thinks once the anti-inflammation medication wore off it came back. His symptoms came back. He was just wondering how long people have been symptomatic after the injection. His next vaccine on 17Feb2021, and his arm was still sore from the first. He felt like this should have been more transient, and in a quicker time frame. The outcome of the events was reported as an unknown.   Follow up received on 05Feb2021: New significant information was received.   Follow-up attempts are completed. No further information is expected.""	Chronic lymphocytic leukaemia; Gastritis	1290813-1	50-59 years	2021/05
294	PFIZER\BIONTECH	INR was 3.7; was up/ went up; The initial case was missing the following minimum criteria: no indication that the patient experienced an event under suspect product BNT162B2. Upon receipt of follow-up information on 20Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm right on 14Apr2021 20:00 (Batch/Lot Number: EW0158) as single dose for covid-19 immunisation. Medical history included leukaemia, and covid. Concomitant medication included warfarin. The patient stated that she took Covid shot on 14Apr2021 and was on Warfarin blood thinner. Her INR was 3.7 yesterday (20Apr2021). Stated that it had went up/ it was up and event onset time was reported as 19Apr2021 16:00. Wanted to double check and make sure everything was alright. Stated she was not having any symptoms and felt fine. Stated that she had leukemia before she started warfarin and COVID shot. She had Covid in January and went ahead and got the shot. The outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.	No current illness for this event.	1291119-1	65-79 years	2021/05
295	PFIZER\BIONTECH	muscle spasms; extreme muscle pain in his back, from his neck to his waist; a lot of stiffness; he can barely walk/ couldn't walk; This is a spontaneous report from a Pfizer-sponsored program, COVAX Support, from a contactable consumer (wife of patient). A 78-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EL9262) via an unspecified route in Feb2021 (reported as both 04Feb and 09Feb) (at the age of 78-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing chronic lymphocytic leukemia (CLL). Concomitant medications included ibrutinib (IMBRUVICA) for CLL, finasteride, tamsulosin, metformin, and glimepiride; start and stop dates unspecified. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3249) in Jan2021 (reported as both 04Jan and 14Jan) as a single dose for COVID-19 immunization. About 2 weeks after the second dose (Feb2021), the patient developed extreme muscle pain in his back, from his neck to his waist. He was in the hospital twice and he was having spasms, then it happened again last week where also a lot of stiffness, he can barely walk, again he just out of blue, he got these muscle spasms and he couldn't walk again. She reported that they have led off but in the meantime, we were trying to figure out if he has done anything, which he did not. She stated the only odd thing was the vaccine. The patient was hospitalized for the events in Feb2021 for about three days, reporter estimated dates as 18Feb2021 and again on 22Feb2021. The muscle spasms ended up going away and then on 12Apr2021 they started up again. Patient had lab test done every 2 months (results not provided). Treatment for events included muscle relaxants, which didn't help. The clinical outcomes of extreme muscle pain in his back, a lot of stiffness, barely walk/couldn't walk were unknown, while of muscle spasms was not recovered.	CLL	1294721-1	Unknown	2021/05
296	PFIZER\BIONTECH	Per pt's wife 1 hour within receiving the vaccine, pt got a fever, headache, and dizziness. She states he took ibuprofen at home . She states that on April 26,2021 pt's primary care physician - was contacted. She states that on April 28,2021 she heard back from him . She states hat on April 29,2021 he went to get lab work (WBC) that md ordered. she states that  pt was contacted on May 1,2021 by primary care physician to go to the ER . She states that he was admitted to hospital from May 1,2021- May 4,2021 and diagnosed with Leukemia (CML)	no	1303917-1	40-49 years	2021/05
297	PFIZER\BIONTECH	Fever; This is a solicited report from consumer (patient) via Pfizer AbbVie Inc. (Mfr. Control No.21K-163-3855391-00). A 71-year-old female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) intramuscular, administered at an unspecified anatomical location on an unknown date (age at vaccination was 71 years) at a single dose for Covid-19 immunisation. On 02Mar2021 (ongoing) patient started treatment with ibrutinib (IMBRUVICA), orally at 1x/day (420 mg,1 in 1) for chronic lymphocytic leukemia. Concomitant medication were not reported. There was no reported medical history. In 2021, the patient experienced Fever with IMBRUVICA (IBRUTINIB). COVID-19 VACCINE was also considered suspect. It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial. The causality for ibrutinib (IMBRUVICA) was not reported. The reporter's causality for the event of fever was not provided. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.	No current illness for this event.	1305357-1	65-79 years	2021/05
298	PFIZER\BIONTECH	Had an antibody test come back negative; This is a spontaneous report from a contactable consumer (wife). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included immunodeficiency, leukaemia (Due to taking chemotherapy) and chemotherapy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced had an antibody test come back negative on an unspecified date. Reporter also mentioned that her 78-year-old husband who is immunocompromised due to taking chemotherapy for leukemia received both doses of the Pfizer BioNTech COVID-19 vaccine and had an antibody test come back negative afterwards. The patient underwent lab tests and procedures which included antibody test: negative (Negative). The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.	No current illness for this event.	1306225-1	65-79 years	2021/05
299	PFIZER\BIONTECH	Increase in white blood cells with peripheral blasts suggesting progression to acute myeloid leukemia	No current illness for this event.	1311425-1	65-79 years	2021/05
300	PFIZER\BIONTECH	Grand Mal seizure; Heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 28Apr2021 at 14:00 (lot number: EW0158) at single dose for COVID-19 immunization. The relevant medical history included epilepsy, childhood leukemia and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19), all from unspecified date. Concomitant medications included lamotrigine (LAMICTAL ODT). The patient experienced Grand Mal seizure and heart palpitations on 29Apr2021 at 18:00. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.	No current illness for this event.	1320056-1	30-39 years	2021/05
301	PFIZER\BIONTECH	fever spiked to 103.7 from a normal of about 97.3; Sore left arm, armpit/ache in forearm; Sore left arm, armpit; Numbness/ache in forearm, slight numbness in hand; bad chills; lot of sweating starting that evening and continuing; runny nose; nausea; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 15:00 (Lot Number: EW0170) as 2nd dose, single for COVID-19 immunisation. Medical history included chronic lymphocitic leukemia, Known allergies to environmental. Concomitant medications included atorvastatin; azelastine; fluticasone propionate (FLONASE ALLERGY RELIEF); metformin, all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number: EW0150) for Covid-19 immunisation on 06Apr2021 in left arm at the age of 59-year-old. The patient experienced sore left arm, armpit, numbness/ache in forearm, slight numbness in hand. bad chills, lot of sweating starting that evening and continuing, a runny nose, nausea, fever spiked to 103.7 from a normal of about 97.3 at about the 23 hour mark, since 27Apr2021 21:00. As of right now 30Apr21 14:21, 3 days later, the patient was still a little sweaty, armpit and arm sore, forearm still ache and hand still a little numb. Since the vaccination, the patient has not been tested for COVID-19. There was no treatment received. Adverse events resulted in Emergency room/department or urgent care. The outcome of events was recovering.	No current illness for this event.	1320106-1	50-59 years	2021/05
302	PFIZER\BIONTECH	unresponsive; had a stroke in his temporal, frontal and parietal regions of his brain and he has even had prior strokes too; feverish; they all fell down, her brother, her and the rollator; rapid heartbeat/ his normal heartrate is in the 60s and it was going from 110 to 140s and it wasn't coming down; had some blood clots that were thrown into the frontal, temporal and parietal region in his brain; agonal breathing; stopped breathing but then he came back so that's when he was intubated; felt very bad/ malaise/ feeling ill; vomiting in the trash can/ had stuff that looked like had came out of his mouth and he had vomit on legs; he just said that he hurt; nauseated; fatigue; his head hurt; having no appetite/ he ate one bowl of soup that the caller had made for him but he wasn't really eating; This is a spontaneous report from a contactable consumer (patient's sister) via a Pfizer-sponsored program. A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 16Apr2021 10:00 (batch/lot number: unknown) as 2nd dose, single for COVID-19 immunisation. Medical history included blood clot years ago, ongoing leukemia (in remission), coma, gout (he takes a gout medicine), neuropathic pain, pain, high blood pressure, thyroid (disorder), varicose veins and uses rollator (his wheelchair with a seat). Concomitant medications included metoprolol taken for high blood pressure from an unspecified start date and ongoing; levothyroxine sodium (THYROXINE) taken for thyroid from an unspecified start date and ongoing; hydrocodone taken for pain from an unspecified start date and ongoing; imatinib taken for leukemia in remission from an unspecified start date and ongoing; gabapentin taken for neuropathic pain from an unspecified start date and ongoing; iron taken for an unspecified indication, start and stop date were not reported; folic acid (FOLATE) taken for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D) taken for an unspecified indication, start and stop date were not reported; and ongoing unspecified gout medicine. The patient previously took morphine; he had a shot of morphine in the emergency room sometime before his COVID vaccine. Historical vaccine included BNT162B2 on 25Mar2021 (batch/lot number: unknown) as 1st dose, single for COVID-19 immunisation. Vaccination facility was PRIVACY she thinks. Prior vaccination (4 weeks prior) were none. The patient's sister reported that they both had their second dose and she forgot to tell the other woman she spoke to about herself because the caller's focus was on her elderly brother who was 72-years-old. They both received their COVID vaccines in the morning of 16Apr2021, a Friday, and within hours her brother felt very bad. She went downstairs and saw her brother vomiting in the trash can and he just said that he hurt and that he felt nauseated. This continued for a few days, in fact it continued for 4 days. He was beginning to feel better on Monday, but he was still not up to par. Then Tuesday she guesses her brother was feeling better. On Wednesday night she went downstairs and heard him around 2300 to midnight talking to the dogs and then the next morning she found him unresponsive (22Apr2021). Her first thought was that maybe her brother had a stroke so she called 911. In the emergency room he had a CAT (computerized tomography) scan and at first they said that he didn't have a stroke. But something very unusual was that her brother had a rapid heartbeat and his normal was around 60 but in the emergency room his heartrate was upwards to 120 to 130 to 140. He was then transferred to another hospital where they said the next evening that in fact he did have a stroke even though that first doctor said that he didn't have a stroke. The doctor didn't find any further information until 2 days later when the doctor thought her brother already had some blood clots that were thrown into the frontal, temporal and parietal region in his brain. She was a biologist so she can't say that the COVID vaccine caused this but she thought that Pfizer should be aware of his situation and then she was so focused on her brother that she forgot to tell the other woman the really bizarre things. She had asked certain questions to the doctor based on what her sister was telling her to ask. The caller asked the doctor if her brother was going to be seen by a neurologist and the doctor gave a rambling evasive answer and then turned on his heels and walked out and kicked her out of the hospital. They both had their COVID vaccines in the morning around 1000 or so and she doesn't know if he was vomiting still the next day or not but her brother felt really bad. He has chronic conditions and he generally just felt bad and he had thought that something was wrong with him. He felt malaise, fatigue, his head hurt and he was nauseated. He ate one bowl of soup that the caller had made for him but he wasn't really eating. That lasted for about 4 days and then he started to feel better on Tuesday, confirmed to 20Apr2021, and then he felt even better on Wednesday, confirmed to 21Apr2021, because the caller did take him on some trips. He doesn't drive. Her brother said that he felt feverish and the caller says that he felt feverish to the touch as well but the thermometer said that he didn't have a fever because it had an error sign when she took his temperature. Unresponsive: Her brother was fine Wednesday night around 2300, maybe midnight, she had heard him downstairs talking to the dogs and she knew that he was okay. Then the next morning, 22Apr2021, she found him slumped into his rollator (his wheelchair with a seat) and he was slumped over and had stuff that looked like had came out of his mouth and he had vomit on legs. He was unresponsive so she called 911 and said that she thought her brother had a stroke. The operator said to lay him flat and the caller was finally able to get him up and then his arm got hung up and the operator said again to get her brother on the floor and get him flat. She understands that this was important and she was able to do it but they all fell down, her brother, her and the rollator. Shortly after this the ambulance had shown up. The ambulance took her brother to the emergency room in town and they said that her brother's heartrate was fast. She gave them all of the relevant information but she didn't think to tell them about the COVID vaccine. They said that her brother's heart was acting eradicate and it was very fast. Again, his normal heartrate is in the 60s and it was going from 110 to 140s and it wasn't coming down. She told them that when he was unresponsive that she thought he was having agonal breathing. In the emergency room, her brother's breathing was still not very good and she heard the doctor say that her brother had stopped breathing but then he came back so that's when he was intubated in the emergency room. They did a CAT scan of his head and his neck and the doctor comes back and said that her brother didn't have a stroke. But that was not the case according to a different doctor's later assessment. Approximately around 1430 to 1445 on that Thursday, 22Apr2021, they transferred him to PRIVACY,  where he was in the ICU (Intensive Care Unit). His heartrate conditioned to being very fast. He went from the emergency room to the ICU. Thursday when he got transferred to the ICU they didn't do any diagnostic tests that day, he was still intubated and his heartrate was still up into the next day, Friday, 23Apr2021. It wasn't until late in the afternoon that a doctor came in and said that her brother did have a stroke he has even had prior strokes too. They had done an MRI (Magnetic resonance imaging) on Friday of his brain, which was not what they did in the first emergency room, that showed that he had a stroke in his temporal, frontal and parietal regions of his brain. At first caller states that on Saturday, he opened his eyes but he was still unresponsive essentially but then she says that this statement was wrong because he actually didn't respond that quickly. He has gone into a coma once before and when he had came out of it a very unpleasant thing happened that was very personal so she was not going to tell it. On Saturday and Sunday the doctor didn't want to answer the callers questions, this was a different doctor than the first ICU doctor and this one didn't have good bedside manner. Finally on Monday, 26Apr2021, her brother started responding. He was moving his legs with purpose, he had tried to kick the nurse, and he had made some words. The day before this, on Sunday the caller had brought the priest in to bless her brother and he sort of nodded and he seemed to make movements but he was still not able to talk. Monday he said what sounded like words and then Tuesday he made, what seemed to her like, meaningful statements. She was told that he had an ultrasound of his neck to see if he had any clogged arteries or veins and the nurse said that the test results came back good that their were no clogs. But this was where the whole story just becomes awful. Caller discusses how there were issues with a cousin having power of attorney from 2015 that was supposedly no longer valid according to the caller and she had spoke with administration and then she got kicked out of the hospital on Tuesday because of a question she had asked the doctor about her brother seeing a neurologist. The doctor said that the neurologist makes his own schedule and it might be 10 days or more if he even decided he wanted to see her brother. When the doctor asked the caller how would she like her brother's care to be she mentioned that he was in a coma before and was being treated for similar circumstances from PRIVACY and that he was seen by a neurologist and she said that maybe her brother should be seen by PRIVACY and the doctor walked out and within minutes she was being escorted out of the hospital for belittling the doctor and calling administration. Now they won't even let flowers be delivered to her brother. Unfortunately the person who has been involved with him the most, the caller, was now barred from him. She was not saying that this was all due to the Pfizer COVID vaccine but why were they saying that she has a blood clot too. She has had headaches but they may be due to stress. She didn't feel sick like her brother. She has a question and she was really scared about the answer. She was just now reading that if you're on immunosuppressant drugs then you're not supposed to have the COVID vaccine. She asked was that true. Well her brother was in remission for leukemia and he was on a cancer medication called imatinib. Caller declined to speak to medical information about this and says it was already too late because he was already taking it and she doesn't know why he didn't stop them. Her brother's friends have tried to call and they were all getting the same statement, which she believes the hospital was stone walling, but the hospital says that they don't have a patient by his name and they have even told the florist the same thing. So caller was unsure if her brother has been discharged or not. He didn't seem to be in the shape to be shipped to a care facility but she doesn't know. It was hard for her to piece it all together. The hospital wasn't feeding her brother enough before she left so for all she knows they could be starving him to death and holding nutrition from him. History/ Investigations: His medications were ones that he has been taking for years and she doesn't know exact start dates for any and if she needs to she can get the dosage information from the pharmacy. Her brother has hid his pills before and he puts them in different bottles, it was a nightmare. He takes a gout medicine and she doesn't know the name of it. Those were the main ones that he takes other than the cancer medicine she said earlier. And he also takes gabapentin for some of his neuropathic pain and he takes something at night and a few others she thinks. For medical conditions the only thing that she knows was that many years ago he had a blood clot but she can't really say what year it was. She does know that her brother wasn't on any blood thinners to he knowledge and not long ago he had an ultrasound of his legs to determine if he had a blood clot but she was not 100 % sure if he had that but she thinks he did. Her brother told her that years ago he had blood clots that were due to weight lifting causing varicose veins and later they collateralized and they found out that the other secondary vessels took over for pumping his blood so it wasn't a problem. Her concern was can someone from Pfizer talk to her about what's going on with her brother, she knows Pfizer doesn't have his records but how will Pfizer be able to determine if this was from the COVID vaccine. She guesses that she was curious about what may of caused the blood clots. She mentioned the COVID vaccine to one doctor and he didn't seem like she respected her knowledge. She asked was there anything that can be done to help her brother if it was a blood clot. She was upset that the hospital and her wanting her brother to see a neurologist and beginning with a claim that he didn't have a stroke and then a claim that he did. She thinks that they were not doing enough for her brother and they were just saying oh well, it was all due to a fast heart rate which can happen as a result of the COVID vaccine. She was going to be honest, she was exhausted and she can't keep talking for a long time. She asked if she can call medical information back later when she was more refreshed. Consumer further stated that her brother had complaints of feeling ill, feverish and having no appetite. Caller stated that the next Thursday she found her brother unconscious, heart rate was elevated 120 to140 beats per minute and that her brother had a stroke. The outcome was recovered on 21Apr2021 for the events Malaise, Nauseated, Fatigue, Headache and Appetite absent; recovering for the event Vomiting; and unknown for the rest of the events.  Information on lot/batch number has been requested.	Leukemia (in remission)	1329459-1	65-79 years	2021/05
303	PFIZER\BIONTECH	Intense nausea; Ringing in ears; This is a spontaneous report from contactable consumer. A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0162, expiry date: unknown) via unknown route of administration on 09Apr2021 at 16:10 as 0.3ml, single dose for COVID-19 immunization. Patient's medical history included hypersensitive esophagus (Feb2020), diabetes, Parkinson's, Lupus nephritis, Leukemia (Dec2000). For hypersensitive esophagus the patient took Amitriptyline 10mg, start date: Apr2020- ongoing, Nexium 20mg (1 per day), Start date: Mar2020, ongoing. The patient underwent lab test for blood test which was normal, covid-19 as negative, and endoscopy on 12Mar2020 that was not too bad; patient's gastro doctor told her it looked like some kind of virus infected me possible covid? he said other than that it didn't look too bad. Concomitant medications included Multi, vit c, vit D 2000, Calcium, on and off for 2 to 3 years ongoing, Levothyroxine 50ml for Underactived thyroid, start date: Taken for 10 to 15 years- ongoing. After vaccination, the patient experienced, In-tense nausea and Ringing in ears on 10Apr2021 at 14: 00. The outcome of event was recovered approximately on 20Apr2021 without treatment.   No follow-up attempts are needed. No further information is expected.	Esophageal disorder (Pertinent details: feb2020 - very ill w. chest pain trouble, breathing, nausea, sinus infection went to hospital sent from w. acid reflux ETC diagnosis not tasted for covid at that time & husband came down with covid in march so I was not tasted until much later when tests were available and was negative for covid. Still have a feel sick, nauseaus feeling after eating. Put on amitriptyline by gastro dr)	1329579-1	Unknown	2021/05
304	PFIZER\BIONTECH	Mitral valve disease; Breathing difficult; This is a solicited report based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-3759679-00). A contactable 77-year-old male consumer received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: not reported: Expiration date: not reported) dose 1 via unspecified route of administration on unspecified date as 1st dose, single for COVID-19 immunisation. The patient received Imbruvica (Ibrutinib) tablet 280mg, once in a day, orally for CLL (Chronic lymphocytic leukaemia). The patient's medical history includes Melanoma. Patient's concomitant medication includes Amlodipine Besylate 10mg for unknown indication, Aspirin (adult low dose) 81mg for unknown indication, Atenolol 100mg for unknown indication, Eliquis (Apixaban) 5mg for unknown indication, Hydrochlorothiazide 12.5mg for unknown indication, Imfinzi (Durvalumab) for unknown indication, Lasix (Furosemide) for unknown indication, Opdivo (Nivolumab) for unknown indication, Pravastatin Sodium for unknown indication on unspecified dates. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On Nov2020 patient experienced breathing difficult and mitral valve disease on unspecified date. The patient had no known allergies. Causality for Imbruvica(Ibrutinib): The reporter's causality for the event(s) of Trouble Breathing with Imbruvica(Ibrutinib) was no reasonable possibility. The reporter's causality for the event(s) of Possible Mitral Valve Issue was not provided.The outcome of all the events was unknown.  Follow-up (07May2021): Follow-up attempts completed. No further information expected. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the information available ,Vaccine BNT162B2 or comirnarity was unrelated to the events dyspnea and mitral valve disease.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.	No current illness for this event.	1332565-1	Unknown	2021/05
305	PFIZER\BIONTECH	BCR-ABL test jumped very high; This is a spontaneous report received from a contactable consumer (patient) via medical information and via Pfizer-sponsored program. An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 80 years old via an unspecified route of administration, administered in arm left on 26Jan2021 (Batch/Lot Number: CN5318) as 2nd dose, single for COVID-19 immunization and bosutinib (BOSULIF), oral from an unspecified date (Batch/Lot Number: unknown) to an unspecified date at 300 mg, 1x/day for chronic myeloid leukemia. Patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right on 05Jan2021 (Batch/Lot Number: EK4176) as 1st dose, single. Medical history included chronic myeloid leukemia. The patient's concomitant medications were not reported. Patient experienced: BCR-ABL (Philadelphia chromosome) test jumped very high on 12Apr2021 (her results went from 1.9 to 11.8). The event was considered related to the medicinal products. Seriousness criteria reported as serious. Outcome of the event was unknown. She has not had any testing since. Action taken in response to the event for bosutinib was dose not changed.	No current illness for this event.	1332682-1	80+ years	2021/05
306	PFIZER\BIONTECH	Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). A 58-years-old-male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733) at single dose via an unknown route in left arm on 27Mar2021 10:00 for Covid-19 immunization. Medical history included hypertension, hairy cell leukemia, and high cholesterol. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included simvastatin, lisinopril, doxazosin, and acetylsalicylic acid (ASPIRIN 81mg). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced atrial fibrillation on 14Apr2021 23:45 requiring cardioversion. The event was assessed as non-serious. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was unknown.	No current illness for this event.	1332768-1	50-59 years	2021/05
307	PFIZER\BIONTECH	chronic lymphocytic leukaemia (CLL); This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated he did not have a response/did not generate any antibodies on an unspecified date after taking the Pfizer-BioNTech COVID-19 vaccine. He stated it was due to having chronic lymphocytic leukaemia (CLL). The outcome of the adverse event was unknown.  Information about the lot/batch number has been requested.	No current illness for this event.	1332814-1	Unknown	2021/05
308	PFIZER\BIONTECH	died; tested positive for covid; tested positive for covid; This is a spontaneous report from a non-contactable consumer. This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukemia untreated since 2018 or 2019. Concomitant medications were not provided. It was reported that on unspecified date, patient got BNT162B2 and later tested positive for covid and died. It was not reported if an autopsy was performed. Lab data included covid test was positive on unspecified date. The outcome of the event died was fatal, while of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died	No current illness for this event.	1332839-1	Unknown	2021/05
309	PFIZER\BIONTECH	ED to Hosp-Admission Discharged  5/4/2021 - 5/10/2021 (6 days)  Treatment team COVID-19 Principal problem   Hospital Course     HPI: Please see H&P for details   Hospital Course:   76-year-old gentleman was admitted to hospital because of COVID-19 pneumonia and respiratory failure with hypoxemia secondary to it.  He was placed on oxygen which was titrated.  He was started on remdesivir and finished the course.  Initially his condition got worsened and ID was consulted and he was given Tocilizumab.  He also was started on dexamethasone from day 1.  His condition has improved significantly.  He is requiring 2 L of nasal cannula.  At this point he is going to finish his course of dexamethasone as outpatient and he will be discharged home with oxygen.  He was also educated about proning and he is very good at this.  He also had remote patient monitoring arranged.  He is going to follow-up with his PCP.  Admission Diagnosis      Medical Problems     Hospital Problems        POA   * (Principal) COVID-19 Yes       Depressive disorder Yes       Type 2 diabetes mellitus (CMS/HCC) Yes       Chronic lymphoid leukemia in remission (CMS/HCC) Yes       Pneumonia Unknown       Acute respiratory failure with hypoxia (CMS/HCC) Yes	No current illness for this event.	1333885-1	65-79 years	2021/05
310	PFIZER\BIONTECH	COVID-19 SOB (shortness of breath) Cough Suspected COVID-19 virus infection Care Coordination Progress Note RN (Registered Nurse)    COVID 19 MAB Infusion Navigator Initial Patient Assessment   Ordering Prescriber has completed required FDA EUA elements.    COVID-19 Positive Result Date (and on chart/file): 5/8/21   Start of Symptoms Date: 5/6/21  Meets Criteria:   ANY AGE: ? Body mass index (BMI) ?35 ? Chronic kidney disease ? Diabetes ? Immunosuppressive disease AGE SPECIFIC: ? ? 65 years of age       ? ?55 years of age AND had Cardiovascular Disease OR Hypertension OR COPD/other chronic respiratory disease   ED to Hosp-Admission Discharged  5/10/2021 - 5/18/2021 (8 days) Treatment team Sepsis due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (CMS/HCC) Principal problem Discharge Summary Discharge Summary   BRIEF OVERVIEW Admitting Provider: MD Discharge Provider: DO Primary Care Physician at Discharge: MD    Admission Date: 5/10/2021     Discharge Date: 5/18/2021   Discharge Diagnosis  Medical Problems     Hospital Problems        POA    * (Principal) Sepsis due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (CMS/HCC) Yes    Overview Signed 5/14/2021 10:50 AM      05/11/2021 Dexamethasone 05/11/2021 Remdesivir            Essential hypertension Yes         CLL (chronic lymphocytic leukemia) (CMS/HCC) Yes         OSA (obstructive sleep apnea) Yes         Persistent atrial fibrillation (CMS/HCC) Yes        DETAILS OF HOSPITAL STAY   Presenting Problem/History of Present Illness/Reason for Admission Patient is an 82-year-old male with past medical history significant for CLL, obstructive sleep apnea, obesity and persistent atrial fibrillation who presented to the ER on 5/10 for evaluation of progressively worsening shortness of breath after recently being diagnosed with Covid?19.  ER work-up concerning for severe sepsis with acute hypoxic respiratory failure for which he was admitted to the PCU under the hospitalist service.   Hospital Course He was treated with dexamethasone and remdesivir but remained hypoxic requiring alternating trials of high flow nasal cannula and BiPAP for which pulmonology was consulted on 5/12.  Unfortunately, he did not tolerate prone positioning.  Despite his advanced age and several risk factors, he slowly but surely progressed from a pulmonary standpoint.  He was weaned off high flow oxygen 2 days ago and deemed stable for downgrade to MedSurg with telemetry at that time.  Since then he has continued to recover well, now requiring 6 L of oxygen with activity and 4 L at all other times.  He is anxious to be discharged home and appears medically stable to do so with home health care services, remote patient monitoring and outpatient pulmonology follow-up with PAL as prior to hospitalization.  Prior to discharge, all questions were answered and patient and his son expressed understanding, appreciation and agreement with the discharge plan at this time.   Treatments: IV hydration, analgesia: acetaminophen, cardiac meds: metoprolol, furosemide and aldactone, anticoagulation: eliquis, steroids: dexamethasone, respiratory therapy: O2 and remdesivir	No current illness for this event.	1336515-1	80+ years	2021/05
311	PFIZER\BIONTECH	Left arm, she is noticing that her left arm is sore too.; she has an elevated White blood Cell Count; Blurry vision right eye; tiredness; This is a spontaneous report from a contactable consumer(patient). A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 14:45 (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included chronic lymphocytic leukaemia, accident, blindness. There were no concomitant medications. The patient reported, blurry vision upon waking up, and tiredness on 29Jan2021. She clarified that she actually only has vision in one eye. The blurry vision is in right eye. With the Left eye, she had an accident as a child and lost her vision in the left eye. She is noticing that her left arm is sore too and had an elevated white blood cell count on an unspecified date. Outcome of the event for blurry vision right eye was recovering and for the other events it was unknown.   Follow-up attempts are completed. No further information is expected.	No current illness for this event.	1345908-1	65-79 years	2021/05
312	PFIZER\BIONTECH	Swollen arm; Injection site red and hot to touch and very sore; injection site is 3 times bigger than it was before; Injection site red and hot to touch and very sore; injection site is 3 times bigger than it was before; Injection site red and hot to touch and very sore; injection site is 3 times bigger than it was before; Injection site red and hot to touch and very sore; injection site is 3 times bigger than it was before; Headache; Body ache/arm from the shoulder to the elbow looks normal it was achy; cellulitis; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6201, Expiry date: Jun2021) via unknown route of administration on 21Feb2021 10:30 AM at single dose for prevention/COVID-19 immunisation. Medical history included LBBB (bundle branch block left, heart problem), osteoarthritis, thyroid (patient was taking thyroid medications, thyroid elevated), chronic lymphoma leukaemia (that has been initiated for 9 years), slight heart problem. Concomitant medications included ongoing furosemide (strength: 10 mg) 10 mg once a day and amlodipine (strength: 10 mg) 10 mg once a day. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL8982, Expiry date: May2021), via an unspecified route of administration on 31Jan2021 (at age of 83-year-old) for COVID-19 immunisation and experienced sore arm. It was reported that patient stated, on 22Feb2021 Monday morning I woke up about 2:00 AM with a headache and all over body ache, on Tuesday I felt a little better, on 23Feb2021 the injection site red and hot to touch and very sore, injection site is 3 times bigger than it was before, on 24Feb2021 Wednesday my arm quite swollen, so I had an appointment with my primary care, they prescribed antibiotics 'Streptomycin' (not clear) 500 mg. This was my 3rd day and my arm was still swollen now 3 times more it was before and very sore."" Consumer added, ""My left hand was also swollen but since I have been on antibiotics that has gone down. By the 24Feb2021 her arm had about the size of a half dollar, a big red spot that was sore and she went to her primary care who gave her an antibiotic called Cephalexin and 2 days later she couldn't get back in there, because there were no doctors available so she went to the Emergency Room which was 30 miles from where they live and they increased the Cephalexin from 2 times per day the 3 times per day and added Bactrim to it as well so she did that for 2 days and then on the 28Feb2021 she went back to the ER because it kept getting bigger and bigger and it was almost down to her elbow and so then they sent her and they admitted her into a ER observation and she stayed there for 3 days and they gave IV Clindamycin and she came home on the 03Mar2021 with 7 more days of Clindamycin to take orally. She has the Cephalexin she had already put them in the bag to be recycled she had just a few tablets left. She sees NDC 67877-0219-05, it says beyond use 27Feb2022 she does not see lot number on the pharmacy vial. It says plan DSER and she sees Ascend labs. On the Bactrim vial it says NDC 65162-0272-10. It was also in a pharmacy vial. It says beyond use 25Feb2022. The Clindamycin IV she received in the hospital. She has the Clindamycin tablets they sent her home with. The Clindamycin is also in a pharmacy vial she does not see lot number. NDC 65862-0185-01 and it says beyond use 03Mar2022. The diagnosis was cellulitis in 2021. She clarifies she first noticed the red spot on her 23Feb2021 it was about the size of a quarter, on the 24Feb2021 it was larger and she went to her primary. It was ongoing but at this point she was a couple days into the antibiotic and the arm from the shoulder to the elbow looks normal it was achy this morning when she woke up at 4am but she was now hoping she was on her way. She was in pretty good health overall. For events vaccination site erythema, vaccination site pain, vaccination site warmth, vaccination site swelling and peripheral swelling seriousness criteria was reported as hospitalization from 28Feb2021 to 03Mar2021 and patient went to emergency room for vaccination site erythema, vaccination site pain, vaccination site warmth, vaccination site swelling and peripheral swelling. The outcome of events headache and general body pain was recovering, cellulitis was unknown and for rest of the events was not recovered.  No follow-up attempts are possible. No further information is expected.""	No current illness for this event.	1349266-1	80+ years	2021/05
313	PFIZER\BIONTECH	Pain in left testicle; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 13Mar2021 08:00 (Batch/Lot Number: En6199) as single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL), chronic obstructive pulmonary disease (COPD), diabetes. The patient had no known allergies. The patient's concomitant medications were not reported. No other vaccine in four weeks. No Covid prior vaccination. The patient had not tested Covid post vaccination. The patient experienced pain in left testicle on 14Mar2021 11:00. No treatment received for AE. Outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.	No current illness for this event.	1349277-1	50-59 years	2021/05
314	PFIZER\BIONTECH	Really bad stiff neck; lump in the neck/lymph node that is a lump in her neck above the collar bone on left side; body aches/Bones aching kind of like the beginning of COVID; headache; having a fever of 101F; Sick; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that:  Serious: No  Patient characteristics:  Sex: Female  Reaction(s)/Event(s): MedDRA version for reaction/event term LLT: N/A Reaction/event in MedDRA terminology (LLT): Medical Information Potential AE  Drug(s) Information: Characterization of drug role: SUSPECT Proprietary medicinal product name: PFIZER-BIONTECH COVID-19 VACCINE   Active Substance Information Active Drug substance names: PFIZER-BIONTECH COVID-19 VACCINE    Narrative case summary and further information:  Case narrative: Originating AE Request: REQ-# Attachments: 1  Reporter Subtype: Patient  PQC Present: No AE Present: Yes  Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE  Question: Caller said she has been transferred from hospital and has reported the AEs (possible duplicate AE); Caller got the first dose of the Pfizer BioNTech COVID-19 vaccine on 25Jan2021 3:22PM in (State name). The next day (26Jan2021), she ended up having a fever of 101F, stiff neck, headache, lump in the neck, and body aches. Her fever broke the next day (27Jan2021) and the other symptoms slowly went away also that day.  She mentioned that she had COVID-19 in Jul. She got hospitalized because of pneumonia. She got discharged for that then 14 days later she was hospitalized again because of her high grade fever and collapsed left lung. She also mentioned that she has an autoimmune disease ""immunoglobulin anemia"" and she has infusions once a week with a medication called ""Hiventa"". She said that she came from a family of doctors and her uncle who is an immunologist recommended her to call Pfizer to see if we do have recommendations about taking the second dose of the Pfizer vaccine considering her conditions.  (This REQ pertains to her AEs after her first dose)  Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE  Question: Caller mentioned that she had COVID-19 in Jul. She got hospitalized because of pneumonia. She got discharged for that then 14 days later she was hospitalized again because of her high grade fever and collapsed left lung. She also mentioned that she has an autoimmune disease ""immunoglobulin anemia"" and she has infusions once a week with a medication called ""Hiventa"". She said that she came from a family of doctors and her uncle who is an immunologist recommended her to call Pfizer to see if we do have recommendations about taking the second dose of the Pfizer vaccine considering her conditions.  Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE  Question: Caller said her uncle who is an immunologist recommends her to go the Emergency Room if her fever breaks to 103F or higher because her lung might collapse. She wanted to know if Pfizer has any recommendations on that.  Follow-up (03Feb2021): This is a follow-up spontaneous report from a contactable consumer. This 60-year-old consumer reported for herself that:  Patient characteristics: Age at time of onset of reaction/event: 60 Age at time of onset of reaction/event (Unit): YEAR Weight (kg): 58.97 Height (cm): 164 Sex: Female  Relevant medical history and concurrent conditions: Structured information (Patient episode name): COVID-19 Patient Medical start date: Jul2020 Patient Medical comments: Verbatim: COVID-19    Relevant medical history and concurrent conditions: Patient Medical start date: 2013 Patient Medical continuing: Yes Patient Medical comments: Verbatim: Connective tissue disease    Relevant medical history and concurrent conditions: Structured information (Patient episode name): Gamma globulinemia Patient Medical start date: 2013 Patient Medical continuing: Yes Patient Medical comments: Verbatim: Gamma globulinemia  Relevant medical history and concurrent conditions: Patient Medical start date: 18Nov2020 Patient Medical continuing: No Patient Medical end date: 18Nov2020 Patient Medical comments: Verbatim: Bladder surgery  Relevant medical history and concurrent conditions: Structured information (Patient episode name): Pleurisy Patient Medical start date: 2016 Patient Medical continuing: No Patient Medical end date: 2016 Patient Medical comments: Verbatim: Pleurisy  Relevant medical history and concurrent conditions: Structured information (Patient episode name): Pneumonia Patient Medical comments: Verbatim: Pneumonia  Relevant medical history and concurrent conditions: Patient Medical start date: 2016 Patient Medical continuing: No Patient Medical end date: 2016 Patient Medical comments: Verbatim: West Nile Virus    Relevant medical history and concurrent conditions: Patient Medical start date: 2015 Patient Medical comments: Verbatim: Sick with all kinds of weird viruses    Reaction(s)/Event(s): Reaction/event as reported by primary source: Sick   Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: UNKNOWN  Reaction(s)/Event(s): Reaction/event as reported by primary source: Bones aching kind of like the beginning of COVID   Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED  Reaction(s)/Event(s): Reaction/event as reported by primary source: Really bad headache   Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED  Reaction(s)/Event(s): Reaction/event as reported by primary source: Fever   Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED  Reaction(s)/Event(s): Reaction/event as reported by primary source: Really bad stiff neck   Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED  Reaction(s)/Event(s): Reaction/event as reported by primary source: lymph node that is a lump in her neck above the collar bone on left side   Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: UNKNOWN  Results of tests and procedures for investigation of the patient: Date: Nov2020 Test: Bloodwork Result: Enlarged red blood cells   More information available (Y/N): No  Results of tests and procedures for investigation of the patient: Date: Jan2021 Test: Bloodwork Result: Normal   More information available (Y/N): No  Drug(s) Information: Characterization of drug role: SUSPECT Proprietary medicinal product name: Pfizer COVID-19 vaccine   Batch/lot number: EL9263   Dosage text: Unknown strength/volume/dose injection to left arm 15:22   Pharmaceutical form (Dosage form): Injection   Indication for use in the case: Vaccination Date of start of drug: 25Jan2021 Action(s) taken with drug: UNKNOWN  Drug(s) Information: Characterization of drug role: CONCOMITANT Proprietary medicinal product name: Hizentra   Dosage text: 9 grams subcutaneously once weekly   Indication for use in the case: Gamma globulinemia Date of start of drug: 2014  Narrative case summary and further information:  Case narrative:  Submitted by Call Centre 1 Ref: #; ININ: # Selected Report Type: Initial Patient Ethnicity: (Ethnicity withheld) Is the patient also the reporter? Yes Reporter type: Consumer or other non-health professional Reporter telephone: (Phone withheld)  Primary / Prescribing Healthcare Professional Info HCP name: Dr. (Name) HCP Occupation/Specialty: Primary Care Physician HCP postal address: (Address withheld) HCP telephone: (Phone withheld)  Dates for Sick: (From: Jan2021 To: Unknown) Dates for Bones aching kind of like the beginning of COVID: (From: Jan2021 To: Unknown) Dates for Really bad headache: (From: Jan2021 To: Unknown) Dates for Fever: (From: Jan2021 To: Unknown) Dates for Really bad stiff neck: (From: Jan2021 To: Unknown) Dates for lymph node that is a lump in her neck above the collar bone on left side: (From: Jan2021 To: Ongoing)  Is Pfizer COVID-19 Vaccine a Pfizer product? Yes Pfizer COVID-19 Vaccine manufacturer: Unspecified  Dates for Pfizer COVID-19 Vaccine: (Start: 25Jan2021 Stop: Unspecified)  NDC number of Pfizer COVID-19 Vaccine: Unknown Expiry Date of Pfizer COVID-19 Vaccine: Unknown  Other Products: Yes Dates for Concomitant Products Hizentra: (Start: 2014 Stop: Ongoing)  Patient History: Yes Patient history: COVID-19 (From: Jul2020 To: Unspecified) Additional Information for Other Conditions: Hospitalized in Jul2020 for this with double pneumonia, left lung collapsed. Because had double pneumonia and collapsed lung she has to see a Pulmonologist for another chest X-ray to see the damage that COVID has done. Patient history: Connective tissue disease (From: 2013 To: Ongoing) Patient history: Gamma globulinemia (From: 2013 To: Ongoing) Additional Information for Other Conditions: 2013 all her cells, everything collapsed: B cells, T cells, C cells were all below average; that's when they realized she had autoimmune disorder Gamma globulinemia and connective tissue disease. Patient history: Bladder surgery (From: 18Nov2020 To: 18Nov2020) Patient history: Pleurisy (From: 2016 To: 2016) Additional Information for Other Conditions: Thinks initially had this in 2016.Hospitalization related to this. Patient history: Pneumonia (From: Unspecified To: Unspecified) Additional Information for Other Conditions: Had pneumonia like 7 times so she is susceptible. Because of this history she has gotten the Pneumonia vaccine and Prevnar 13 vaccine. Prevnar 13 when she was too young, in her 50s like 4-5 years ago because had pneumonia so many times. Prevnar 13:Lot/NDC/Expiry: Unknown, does not have product. She thinks there is a Prevnar 23 now she will have to look into. Patient history: West Nile Virus (From: 2016 To: 2016) Additional Information for Other Conditions: Hospitalized for this. Patient history: Sick with all kinds of weird viruses (From: 2015 To: Unspecified) Additional Information for Other Conditions: Started getting sick a lot with all kinds of weird viruses that she was hospitalized for starting when she moved to (State name) around 2015  Investigation Assessment: Yes  Additional Context: This consumer was administered her first dose of Pfizer COVID-19 Vaccine 25Jan2021. She reported before she got Pfizer COVID-19 Vaccine she had history of COVID in Jul2020. After administered Pfizer COVID-19 Vaccine she initially started getting sick unknown date and time, but either around night of 25Jan2021 or 26Jan2021. Sick further described as: started with her bones aching kind of like the beginning of COVID, then really bad headache, then fever. She also had a really bad stiff neck that went away. Fever started at night she thinks 26Jan2021; Temperature reached 101 degrees Fahrenheit; by the next day when she woke up her fever broke. She still had a little bit of a headache. As the day went on all the sick symptoms went away. She still has a lymph node that is a lump in her neck above the collar bone on left side-that is the only thing still ongoing with unknown outcome. The bones aching kind of like the beginning of COVID felt like she did in the beginning when she had COVID in Jul2020. She recovered completely from all the other events on unknown dates. She is not sure if she should call her surgeon about the lymph node that is a lump in her neck. She thought it was kind of unusual to have that kind of a reaction to the first dose of Pfizer COVID-19 Vaccine; she called to ask if these events are normal with the first dose of the Pfizer COVID-19 Vaccine; and if there are recommendations regarding getting the second dose relative to these events.    Reporter: Email: Unknown. Primary: Email: Unknown. Pfizer COVID-19 Vaccine: NDC/Expiry: Unknown, this is not on the CDC vaccine record card she was given. Second dose is scheduled 15Feb2021 Unknown if dose will continue unchanged at this point Primary/Prescriber: Email: Unknown.  VACCINE SUPPLEMENTAL FORM: Patient Details: Patient Last Name: (Name) Patient First Name: (Name)  Address: (withheld) City: (withheld) State: (withheld) Zip Code: (withheld) Phone: (withheld) Patient Age at Time of Vaccination in Years: 60 Pfizer Suspect Vaccine and Vaccination Details: Vaccine Lot Number: EL9263 Vaccine Lot Expire Date: Unknown, not on CDC vaccine record card Time the Vaccination Was Given (24 hour clock): 15:22 Anatomical Location of Administration of Pfizer vaccine considered as suspect: Arm Left For US Only: Vaccination Facility Type: They turned a sports stadium parking lot into a vaccination center For US Only: Vaccine Administered at Military Facility?: No For US Only: Vaccination Facility Address: Facility Name: (withheld) Address: (withheld) City: (withheld) Zip Code: Unknown  State: (withheld) Phone: Unknown History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: None. Adverse Event (AE) Details: Provide the time of onset of AE(s): Adverse Event: Sick  Time of Onset (24-hour clock): Unknown Adverse Event: Bones aching kind of like the beginning of COVID Time of Onset (24-hour clock): Unknown Adverse Event: Really bad headache Time of Onset (24-hour clock): Unknown Adverse Event: Fever  Time of Onset (24-hour clock): Unknown Adverse Event: Really bad stiff neck Time of Onset (24-hour clock): Unknown Adverse Event: lymph node that is a lump in her neck above the collar bone on left side Time of Onset (24-hour clock): Unknown Did any AE(s) require a visit to: Emergency Room?: No  Physician Office?: No If the patient was hospitalized, how many days was the hospital stay?: Not applicable, not hospitalized. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: All relevant information documented in formal fields of other conditions. Family Medical History Relevant to AE(s): Father has heart disease; has a defibrillator; pacemaker and celiac disease. Cancer runs in her family. All of her sisters have had breast cancer, all of her cousins have had breast cancer, all 3 of her aunts died of breast cancer; and another aunt died of leukemia myeloma acute.  Relevant Tests: She takes care of herself and has mammograms. She had some bloodwork done in Nov2020 before bladder surgery, and that bloodwork showed enlarged red blood cells. They did follow up bloodwork in Jan2021 and everything came back normal with that bloodwork. Because cancer runs in her family so strongly she is under the care of a hematologist and cancer specialist. She has bloodwork done every 3 months because when providers looked at her history and hospital history her bloodwork is all over the place, up and down historically.  Is there a Product Complaint: Yes  Description of Product Complaint: This consumer was administered her first dose of Pfizer COVID-19 Vaccine 25Jan2021. She reported before she got Pfizer COVID-19 Vaccine she had history of COVID in Jul2020. After administered Pfizer COVID-19 Vaccine she initially started getting sick unknown date and time, but either around night of 25Jan2021 or 26Jan2021. Sick further described as: started with her bones aching kind of like the beginning of COVID, then really bad headache, then fever. She also had a really bad stiff neck that went away. Fever started at night she thinks 26Jan2021; Temperature reached 101 degrees Fahrenheit; by the next day when she woke up her fever broke. She still had a little bit of a headache. As the day went on all the sick symptoms went away. She still has a lymph node that is a lump in her neck above the collar bone on left side-that is the only thing still ongoing with unknown outcome. The bones aching kind of like the beginning of COVID felt like she did in the beginning when she had COVID in Jul2020.  Pfizer COVID-19 Vaccine: NDC/Expiry: Unknown, this is not on the CDC vaccine record card she was given.  Follow-up (13May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.""	Connective tissue disorder (2013 all her cells, everything collapsed: B cells, T cells, C cells were all below average; that's when they realized she had autoimmune disorder Gamma globulinemia and connective tissue disease); Gamma globulinemia (2013 all her cells, everything collapsed: B cells, T cells, C cells were all below average; that's when they realized she had autoimmune disorder Gamma globulinemia and connective tissue disease)	1353142-1	60-64 years	2021/05
315	PFIZER\BIONTECH	passing out/sort of out of body-ish awareness; Patient had never had a seizure, but it felt more like that than a faint; Felt heavy in upper arms/chest; Felt heavy in upper arms/chest; feeling uncoordinated walking through house; felt out of body; felt pain in knees/pain in right knee; joints seizing/cracking really hard; abrasions on both of knees; Moderate damage to L mcl; Must have fallen; stinging spot in the back of head; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171) via an unspecified route of administration, administered in arm left on 01May2021 09:00 (at the age of 57-year-old) as single dose for COVID-19 immunization. Medical history included leukemia from 1998, breast cancer from 2001. No Known allergies. Concomitant medications were not reported. The patient previously received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0164) on 10Apr2021 08:00 AM (at the age of 56-year-old) in left arm for Covid-19 immunization, then experienced adrenal disorder and epinephrine increased. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient woke up Tues, 04May2021 08:00 AM. Felt heavy in upper arms/chest. Started feeling uncoordinated walking through house. Didn't remember actually passing out but felt out of body and felt pain in knees, and joints seizing/cracking really hard. sort of aware something was happening, but sort of out of body-ish awareness. Came back to awareness. abrasions on both of knees, moderate damage to L mcl. pain in right knee. must have fallen but no awareness of that - came to laying on back. Patient had never had a seizure, but it felt more like that than a faint. Also noticed a stinging spot in the back of head that seemed to travel up the back of skull for several days. Treatment was not received for the adverse event. Reporter assessed events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event ""passing out/sort of out of body-ish awareness"" was recovered in May2021, of other events was unknown.""	No current illness for this event.	1357293-1	50-59 years	2021/05
316	PFIZER\BIONTECH	her mother's body was full blown with leukemia/she wasn't responding/leukemia was back; Second dose: breathing heavy; Second dose: screaming in agony and pain because her sides were blowing up in pain; Second dose: She had no red blood cells that could provide oxygen to her organs; Second dose: weak; Second dose: overproducing of her white blood cells; Second dose: wasn't acting like herself; Second dose: more tired; Second dose: she could hardly talk; Second dose: she couldn't stand up; Second dose: she lost control of her bowels; Second dose: hollow cough; This is a spontaneous report from a contactable consumer. A 96-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Mar2021 (Batch/Lot Number: EP6955) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Leukaemia in 2018, High blood pressure with 40 years, Diabetes in 2016, Atrial fibrillation in 2018.The patient's concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (Batch/lot number: EN6199) in left arm on 07Mar2021 for COVID-19 immunization. She had just had her blood drawn in Feb2021 and her blood was ok. So on 07Mar2021 she received her first Covid 19 vaccine. At 96 years old, after the Covid 19 vaccine, her mother's body was full blown with leukemia. Radiation wasn't an option to stop the overproducing of her white blood cells. The Covid 19 vaccine just accelerated it. Maybe there are others out there in this condition and should be double checking to see if they should get the Covid 19 vaccine.  On the 12Apr2021 or 13Apr2021 her mother started having a hollow cough. She wasn't congested but she continued to cough. She noticed her mother was breathing heavy and fighting to breathe on Friday, on16Apr2021. It wasn't getting any better and she thought her mother would have more trouble so she took her to the emergency room. She reported she took her mother to the hospital on 16Apr2021.She was admitted on 16Apr2021 and discharged on 18Apr2021. They gave her some oxygen and did some tests. They asked her mother if she had chronic obstructive pulmonary disease and she did not, they suggested that it was her atrial fibrillation. She has had atrial fibrillation in the past, her doctor did leave her on her atrial fibrillation medication. She can't recall the name of the atrial fibrillation medication. She was discharged home on 18Apr2021 and she was breathing ok on her own. But by that next Tuesday, 20Apr2021, she noticed her mother was declining. She wasn't acting like herself. On Wednesday, 21Apr2021, she was more tired and her difficulty breathing started back up. On Thursday, 22Apr2021, she called the ambulance to take her mother to the hospital. She could tell that her mother wasn't herself, she could hardly talk on 22Apr2021 , she couldn't stand up, she lost control of her bowels. She wasn't responding to her. The caller knew something was going on. They put oxygen on her mother and they transferred her to a cancer specialist hospital. That's when the doctor realized it was a leukoblast. Clarified with caller, leukoblast. Then her mother died. She died on 28Apr2021.The caller knows the hospital was doing tests to see what was causing her mother's pain, but she doesn't have that information. She heard the screams from her mother and there was no consoling her mother. The hospital gave her mother morphine and it didn't work. She has no product information for the morphine, it was given in the hospital. She was screaming for murder, screaming for help and was given the morphine. Within a month of receiving the Covid 19 vaccine her leukemia was back and her mother was screaming in agony and pain because her sides were blowing up in pain. Whatever the Covid 19 vaccine did in her body, her body thought it was fighting off something. She had no red blood cells that could provide oxygen to her organs. She was weak. Overproducing of her white blood cells on an unspecified date. The lab data included White blood cell count abnormal and Red blood cell count decreased. Outcome of her mother's body was full blown with leukemia/she wasn't responding was fatal, of remaining events was unknown. Treatment received for all events. The seriousness of event breathing heavy and fighting to breathe were reported as hospitalization from 16Apr2021 to 18Apr2021. The seriousness criteria of she wasn't responding was reported as hospitalization from 22Apr2021 to 28Apr2021.; Reported Cause(s) of Death: Fatal Neoplasm progression	No current illness for this event.	1357338-1	80+ years	2021/05
317	PFIZER\BIONTECH	This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, COVAX US SUPPORT. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient also received first dose of BNT162B2 in Feb2021 for COVID-19 immunisation and experienced little pain at the point of the injection (first vaccine was not given properly). The patient received two doses of the Pfizer COVID vaccine in Feb2021 and he had some doubt about the second vaccine experience whether he got a full dose unlike the first. His first experience he got the needle, he felt the pinch, and got the vaccine hit his muscle inside, it was hard to describe for the patient, but it was an interior sensation. He mentioned that he didn't had any of those sensations with the second dose and also, had a little pain at the point of the injection of the first one. So, the second one, it was so minimal. He went inside for 15 minutes and soon as he was ready to get up and leave and he tried to go back to the vaccine administration station to find the team who administered the vaccine to him, but they were no longer there. So, he told their supervisor that there was something wrong with his 2nd dose.  He couldn't find a new 'run break' or something.  The patient further stated, ""So anyways I hoped it was nothing and I kind of took that for granted that I got something if not maybe wasn't a full dose or whatever"".  Then two weeks ago, the patient decided to make a doctor's appointment to get the 'Anti' SARS CoV-2, Spike Protein Antibody Test and his number came back with its right above, it's little bit above the number for the person to have one dose of the vaccine and it's about 70% lower than the lowest immune response, the lowest number of antibody a person would have received with the two doses. 8 weeks later, he got a  test to test for the RBG binding site of the spike protein. He took the test twice: 1st reading: 194.5 units per ml; 2nd reading: 194.1 units per ml. He said the test somehow confirmed that he did not get a normal antibody response with the 2nd dose. He said the level of antibodies he had were just above the mean for a person who received just the 1st dose. He said the lowest antibody count for persons who have received both doses were 795 to 800 units per ml, and his falls below this. He also mentioned that only people who have chronic lymphocytic leukemia were the only ones who had less than 795-800 units per ml. With this, he wants to know if there is any way he can get a repeat of his 2nd dose, or if he can get a 3rd dose somewhere.  The patient mentioned that there were things about the second dose administration that made him think that he was under dosed. His antibody titer levels came in exactly just slightly above the number that is for person who had only one dose. Immunity is going to diminish as it is not that great, it is about a tenth as high on average as the immunity that should have come from the second shot. It should have been much more immunity with the second shot, and it doesn't look like he had a second shot. It doesn't look like he has got much serum. And there about he had looked at the studies of the distribution and not trying to make a claim about the immunity. The patient further stated, ""What I am making the strong claim about the correlation between the number of antibody that they took up in this test and rather one got one or two doses and there is not a single person in the five studies, in the part of gigantic studies of 500 person, there is not a single person who's received two full doses who has an antibody title level that is as low as mine except for somebody with, there were two people with CL low that is the chronic Leukemia low, leukemia who has zero antibodies. So I look at this all and I believe that I somehow got a very substandard second dose and I spoke to number of doctors and I hope my doctors and doctors that are friend of mine that teach at different medical school, they all agree with the analysis but nobody knows how to go about getting an authorization for the third dose"".  The patient mentioned that he tried his doctors and they don't have any idea because it's not something that's prescribed, it's the matter of CDC rules and he have called and written to the department of public health in agony and he got no information back as to how he can proceed.  The patient stated he must have had the substandard amount of the serum because he is not immunocompromised in anyway. He checked that out, had his doctor double checked, look at the CDC and he is not immunocompromised, so it is not even that he is at the low end of spectrum of those who had received the second dose. The patient was wondering if Pfizer have any recommendations as to how he should proceed. He had no doubt unfortunately that he had substandard, he must have had the substandard amount of the serum because he was not immunocompromised in anyway.  The patient mentioned that he had 100's of point below at every scale that was different. Outcome of the event was unknown.   Information about the lot/batch number has been requested.""	No current illness for this event.	1360453-1	Unknown	2021/05
318	PFIZER\BIONTECH	acute appendicitis; intense abdominal pain; This is a spontaneous report from a contactable nurse. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (Batch/Lot Number: EJ1686; Expiration Date: May2021) as 2nd dose, single dose (at the age of 52 years) for covid-19 immunization. The patient's medical history included acute lymphoblastic leukemia and s/p BMT (s/p BMT 1993, no chronic health conditions). Thepatkent didi not receive any other vaccines within 4 weeks prior to the Covid-19 vaccine. Concomitant medications included estradiol (ESTRADIOL); norethindrone acetate (NORETHINDRONE ACETATE) taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 on 05Jan2021, 10:00am (lot:EJ1686, expiration: Mar2021) at the age of 52 years for Covid-19 immunisation. Wednesday morning around 9am on27Jan2021, patient went home early from work with intense abdominal pain. She was admitted to the hospital Thursday(28Jan) around 2am and was diagnosed (on CT) with acute appendicitis. Patient had an appendectomy on 28Jan2021 around 11am. The outcome of the events was recovered on 28Jan2021.   Information on Lot/Batch number was available. Additional information has been requested	No current illness for this event.	1360489-1	50-59 years	2021/05
319	PFIZER\BIONTECH	Rapid heart rate up to 163 bpm. 2.5 hours, unable to reduce. Required emergency pharmaceutical intervention.; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration in right arm on 09Mar2021 at 15:15 (at the age of 75-years-old) at unknown, single dose for COVID-19 immunization. Medical history included chronic lymphocytic leukaemia (CLL) and penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine and fluticasone propionate. The facility where the most recent COVID-19 vaccine was administered was reported as other. On 14May2021 at 09:00, the patient experienced rapid heart rate up to 163 bpm which has not reduced in 2.5 hours. The event required emergency pharmaceutical intervention with intravenous (IV) dialtiazem, diltiazem 120 mg, and ELIQUIS 5 mg 2x, doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included heart rate: rapid heart rate up to 163 bpm and nasal swab for COVID-19: pending result, both on 14May2021. The outcome of the event was not recovered. The event was reported as non-serious.	No current illness for this event.	1360506-1	65-79 years	2021/05
320	PFIZER\BIONTECH	Leukemia developed after second shot; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. It was unknown if the patient was diagnosed with COVID-19 since the vaccination. The patient previously took 1st COVID-19 vaccine shot and got lymph nodes swelled. On unspecified date, the patient experienced leukemia after second shot. The outcome of the event was unknown.  follow-up attempts are possible. further information is expected	No current illness for this event.	1360611-1	Unknown	2021/05
321	PFIZER\BIONTECH	Pneumonia; This is a solicited report from a contactable consumer, based on information received by Pfizer (Mfr. Control Number: 21K-163-3826688-00), from a non-Pfizer marketing program (marketing program name not available). A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a 1st dose, single for COVID-19 immunisation and ibrutinib (IMBRUVICA), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 420 mg daily for chronic lymphocytic leukaemia.  Medical history included diabetes mellitus and allergies IV-dye, both from unknown dates. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications included apixaban (ELIQUIS); lisinopril (LISINOPRIL); loperamide hydrochloride (LOPERAMIDE HYDROCHLORIDE); pantoprazole sodium anhydrous (PANTOPRAZOLE SODIUM ANHYDROUS); tamsulosin hydrochloride (TAMSULOSIN HYDROCHLORIDE); colecalciferol (VITAMIN D3); all taken from unknown dates for unspecified indications.  On 11Mar2021 the patient experienced pneumonia. The patient was hospitalized for pneumonia from 11Mar2021 to 19Mar2021.  The action taken in response to the event for ibrutinib was temporarily withdrawn on an unspecified date. The outcome of the event pneumonia was recovering. The causality assessment for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the event pneumonia was not provided by the reporter.  The reporter's assessment of the causal relationship of the pneumonia with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.  Follow-up (18May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Based on the current available information, the event Pneumonia is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.  The case will be reassessed if additional information becomes available.	No current illness for this event.	1367053-1	Unknown	2021/06
322	PFIZER\BIONTECH	At about 3pm on 05-01-2021, my daughter started acting crazy. She does have a history of leukemia which was treated 07-03-2020. She has history of neurological problems from chemotherapy. She also has down syndrome. She has headaches since the vaccine. She is non speaking, non-verbal. After her Pfizer vaccine, my daughter repeat things over and over, at night she cries, moves her hands a lot, yells when she is at school. My daughter did not have a fever, body aches after her vaccine. I feed her, bathe her and take care of her and since receiving the Pfizer vaccine she is not the same person. Before the vaccine, my daughter was sociable, respected, educated but since the vaccine she has been out of control and acting crazy.   My daughter received the Pfizer vaccine at a clinic and the doctors there said that she should not get the second dose. At this time, my daughter is scheduled for an MRI appointment on 06-18-2021.	No current illness for this event.	1368667-1	6-17 years	2021/06
323	PFIZER\BIONTECH	Rash on eyelids and arms after 2nd Pfizer COVID vaccine; Rash on eyelids and arms after 2nd Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer (patient's friend) reported for a 65-year-old-male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported), dose2 via unspecified route of administration, on an unspecified date (at the age of 65-years-old) as single dose for COVID-19 immunization. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported), via unspecified route of administration, on an unspecified date, at a single dose for COVID-19 immunization. The patient's medical history included leukemia as a child and had not had a reaction to a vaccine before. Patient's concomitant medications were not reported. On an unspecified date, the patient experienced rash on eyelids and arms after 2nd Pfizer COVID vaccine. He had been to allergist who provided a steroid cream for arm and said not to put on eyelids. The reporter stated that this occurred close to 3 months ago and still has not resolved. He has a dermatologist appointment on 03Jun2021. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.	No current illness for this event.	1370731-1	65-79 years	2021/06
324	PFIZER\BIONTECH	extreme vertigo; unable to move head or body without vertigo worsening; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 28Feb2021 as 1st dose, single dose for covid-19 immunisation (at the age of 73-year-old). Medical history included hypertension, chronic lymphocytic leukaemia, prostate cancer, malignant melanoma and blood pressure abnormal. Concomitant medication included BP medications (unspecified) in two weeks. Patient did not receive any other vaccine in four weeks. Patient no covid prior vaccination. No covid tested post vaccination. No known allergies reported. On 28Feb2021, the patient experienced extreme vertigo and unable to move head or body without vertigo worsening. Patient did not receive any treatment for events. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.	No current illness for this event.	1373482-1	65-79 years	2021/06
325	PFIZER\BIONTECH	soreness; headache; bilateral hamstring muscle pain; This is spontaneous report from a contactable other Health Care Professional via Pfizer sponsored program. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration on 26Jan2021, as a single for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration on 05Jan2021, as a single for COVID-19 immunization. The patient's medical history included Chronic Lymphocytic Leukemia and some particular type of anemia. She received IVIG treatment every 30-32 days. Concomitant medications included Intravenous Immunoglobulin (IVIG) treatment every 30-32 days. On an unknown date, the patient experienced bilateral hamstring muscle pain, soreness and headache. On 26Feb2021, the patient underwent blood test to detect antibodies against COVID infection and the result was negative. The Reporter wanted to know what are all the other tests they can do and also stated that he heard that muscle pain has been reported 38% post vaccination. He wanted to know if muscle pain can progress to myalgia. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. It was reported that antibodies in some persons can be detected within the first week of illness onset. In SARS-CoV-2 infections, Immunoglobulin M and Immunoglobulin G antibodies can arise nearly simultaneously in serum within 2 to 3 weeks after illness onset. Thus, detection of IgM without IgG is uncommon. How long IgM and IgG antibodies remain detectable following infection was not known. It was also important to note that some persons do not develop detectable IgG or IgM antibodies following infection. Thus, the absence of detectable IgM or IgG antibodies does not necessarily rule out that they could have previously been infected. The outcome of the events was unknown.  No follow-up attempts are possible. No information about lot/batch number has been requested.	No current illness for this event.	1373499-1	65-79 years	2021/06
326	PFIZER\BIONTECH	Stomach was off; She has lost weight; Can't get out of bed if she's lying flat unless she's able to pull on things; Weakness has made her afraid to walk down the stairs; Tired; Exhausted; Very high temperature; Extremely weak; Muscle weakness; This is a spontaneous report was received from a contactable nurse (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6204 and Expire Date: unknown) in left arm, via unspecified route of administration, on 15Mar2021 as 2nd dose, single dose for Covid-19 immunisation. Patient's medical history included ongoing Parkinson's disease, Chronic lymphocytic leukaemia, Sleep apnoea, Chronic fatigue, Hypothyroidism. She has not had any changes to her medications. She has taken the same medications for years. She declines to provide her medication information. The patient also had slight allergy (vomiting) due to Miralax in the year 2012. She had the Miralax in 2012 when she broke her hip, she was at a rehab hospital. The hospital didnt have any prunes so they gave her Miralax twice. The patient's concomitant medication included IgG infusions every 4 weeks. She received her IgG infusion on the days after she received her first and second Covid 19 vaccine. She has been getting IgG for 15 years. She took Tylenol and Benadryl and Prednisone to get her IgG. On 22Feb2021 at 10:30, the patient had received 1st dose of vaccine (Batch/lot number EM9809) on left arm and experienced gas. On 15Mar2021, the patient's temperature was as high as 101.7 degrees Fahrenheit. She did not take any Tylenol for her high temperature because she was told not to with the Covid 19 vaccine. She did ultimately take Tylenol for her temperature and her fever came down. She doesnot recall the exact temperature. It had gone up to 100.9 degrees Fahrenheit and then over the next few days it was around 99 degrees Fahrenheit. She thought she was weak because of the high temperatures. Her stomach felt off, but she drank some Ginger ale. She was weak, tired, and exhausted. She also had her blood tested for Covid 19 antibodies and she was negative for antibodies. Now her primary care doctor is concerned with her muscle weakness and thinks she now has an advanced case of Parkinsons disease. She does have a history of Parkinsons disease before-hand. She had an EMG (Electromyographic Nerve Test) last Thursday, 20May2021 and she has had blood work that has ruled out Myasthenia Gravis and ruled out Guillain-Barre. Her weakness has made her afraid to walk down the stairs. She had to have someone pull her up to the side of the bed. she has lost weight. She reports the temperatures are gone but the weakness has gotten worse. She still cannot get out of bed if she was lying flat unless she was able to pull on things. Her doctor told her she should report her side effects. She just got off the phone with reporting hotline. She reports she has no immunity because of her cancer, and she was hoping she can still receive the Covid 19 vaccine booster if needed. The patient did not receive any vaccine prior to covid-19 vaccine but had sore arm for any vaccine that he had received. Five months ago, she was able to hike and do yard work and now she was basically housebound, mostly. She has been to her primary care doctor on 06Apr2021, and she went to her gynecologist for a routine visit on 07Apr2021. Her gynecologist was upset because she looked so weak. She went to the Cancer clinic on 13Apr for an IgG infusion. She saw a urologist on 07May2021 for a routine appointment. Her appointments with the urologist and gynecologist were not related to her experience with the Covid 19 vaccine. She has had lots of conversations with her neurologist and had not written down the dates she has talked to him. She saw her primary care doctor again today on 28May2021. Her cancer doctor, primary care doctor and her neurologist have all been talking together about her case. The patient undergone lab tests which included body temperature on 15Mar2021,101.7 Fahrenheit and unspecified date in Mar2021, 100.9F and 99F and in Mar2021, SARS Cov-2 test results was negative, weight measurement showed decreased weight, on 20May2021, Electromyographic Nerve Test and blood work reports included Myasthenia Gravis and Guillain-Barre. On an unspecified date in 2021, the patient was recovered from very high temperature and not recovered from extremely weak, muscle weakness, stomach was off, tired, exhausted and weakness has made her afraid to walk down the stairs and outcome of lost weight, can't get out of bed if she's lying flat unless she's able to pull on things was unknown.	Chronic fatigue (Verbatim: Chronic fatigue); Chronic lymphocytic leukemia (Verbatim: Chronic lymphocytic leukemia); Hypothyroidism (Verbatim: Hypothyroidism); Parkinson's disease (Verbatim: Parkinson's disease); Sleep apnoea (Verbatim: Sleep apnea)	1373876-1	65-79 years	2021/06
327	PFIZER\BIONTECH	At approximately 1442, client reports to nurse feeling dizziness, sweating, shakiness, palpitations and blurred vision and stated ? it feels like my sugar is low.? Patient reported she did not have glucometer and had been feeling like this for 10 minutes.  EMT assessed patient vitals: blood pressure 140/90 mmHg, pulse 110 beats/minute and SpO2 99%. Patient reported history of diabetes mellitus type 2, asthma, leukemia, and ovarian cancer. Patient reported taking metformin, insulin, and an inhaler. At 1443, nurse activated EMS. At 1451, paramedics arrived and assumed care. Patient blood sugar was 123. Patient declines transport to hospital and signed Against Medical Advice form. At approximately 1500, paramedics left facility. Patient vitals reassessed at 1505: blood pressure 130/90 mmHg, pulse 102 beats/minute, and SpO2 99%. Patient stands up and reports feeling dizzy again. Nurse offered crackers. Patient consumed crackers and stated she felt better and was not dizzy anymore. At 1316 lead nurses assisted patient who is pushing her mother in a wheelchair to her vehicle. Patient left facility with steady gait and unlabored respirations.	None	1375640-1	40-49 years	2021/06
328	PFIZER\BIONTECH	Shaky; Warm; My face turned red; My hands were shaking; I felt my heart skipping with irregular heart beats; The nurse measured my blood pressure and it was 183/95 with a pulse of 104; This is a Spontaneous report from a Contactable Consumer (patient, self-reported). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Feb2021 at 08:30 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included hypertension, chronic lymphocytic leukemia, osteoporosis, glaucoma and known allergies: reaction to epinephrine (cannot have Novocain with epinephrine), reaction to histamines and tyramine. Concomitant medications included metoprolol succinate (TOPROL XL), Amlodipine, Levothyroxine, and Atorvastatin. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 03Feb2021, about 7-10 minutes after receiving the shot, she started to feel extremely shaky and warm. Her face turned red, and her hands were shaking. She felt her heart skipping with irregular heartbeats. The nurse measured her blood pressure, and it was 183/95 with a pulse of 104. She was observed for an hour. The patient did not receive treatment for the events. Outcome of the events was recovered on an unknown date in Feb2021.  Follow-up attempts completed. No further information expected.	No current illness for this event.	1375734-1	65-79 years	2021/06
329	PFIZER\BIONTECH	2 inches raised red and itchy rash on left upper arm at site of injection.; 2 inches raised red and itchy rash on left upper arm at site of injection.; 2 inches raised red and itchy rash on left upper arm at site of injection.; covid test; This is a spontaneous report from a contactable consumer (patient, reported for self).  A 72-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for Injection; Batch/Lot number: 6/2021; Expiration date: UNKNOWN), via an unspecified route of administration, administered in Left arm on 25Feb2021 11:15 (at the age of 72-year-old) as single dose for COVID-19 immunization. The patient known allergies: Penicillin; other medical history included CLL (Chronic lymphocytic leukaemia), HBP (Blood pressure high), anxiety. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medications included losartan, cefalexin monohydrate (LEXIPRON), rosuvastatin calcium (CRESTOR), etodolac (LODINE) all taken at an unspecified dose for unspecified indications from unspecified date and unknown if ongoing. The patient did not receive other vaccines prior to the COVID vaccine within 4 weeks.   The patient experienced 2 inches raised red and itchy rash on left upper arm at site of injection on 06Mar2021 20:00 (reported as 08:00 PM). The patient underwent lab tests and procedures (COVID tested post vaccination) which included nasal swab test on 04Mar2021, result: Unknown. The patient had tested for COVID-19 post vaccination. The patient did not receive any treatment for the events. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.	No current illness for this event.	1375886-1	65-79 years	2021/06
330	PFIZER\BIONTECH	Severe pain in right lower back; Severe pain in right lower back; traveled to lower right abdomen; It left a numb feeling behind; The caller thinks he has a rare case of shingles happening; Slight swelling on right side; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 48-year-old, via an unspecified route of administration, administered in left deltoid on 23Apr2021 (Lot Number: EW0171; Expiration Date: 31Aug2021) as 1st dose, single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia from 2021 and ongoing (states he was diagnosed about 2 months ago) and had shingles once already when he was 20 years old. The patient's concomitant medications were not reported. The patient stated that he had the first dose of the vaccine on 23Apr2021. The patient experienced severe pain in his right lower back on 23Apr2021. He spent 24Apr2021, 25Apr2021, and 26Apr2021 at the hospital in the Emergency Room getting treated for severe pain in his right lower back. He states they ran all kinds of tests, but they could not figure out what was going on.  States he was not admitted to the hospital during that time; he was treated for severe pain in his right lower back in the Emergency Room. The patient mentions that his wife also had the vaccine and she had a sore arm and some body soreness, but she wasn't sick or anything like that. He states he was still recovering from severe pain in his right lower back. The pain migrated from his back around to the lower right side of his abdomen on Apr2021. States that it left a numb feeling behind on Apr2021. The patient stated that after reading and after seeing 5 doctors; the patient told his oncologist that he thinks he has a rare case of shingles happening on Apr2021. He thinks it was the very rare kind where you don't have a rash appear. He had shingles once already when he was 20 years old. This time he thinks that was what it was again with no rash, just pain and discomfort. The severe pain in his right lower back was much better than it was. Says his skin looks normal. There was some slight swelling on his right side on Apr2021. The patient states that when it was time for his second dose of the vaccine, he hadn't recovered from the first dose. He did not go get his second dose; states his doctor agreed with that decision. Severe pain in right lower back, traveled to lower right abdomen resulted in emergency room and physician office visit. The patient underwent lab tests and procedures on Apr2021 which included CT scan (they were checking his lymphatic system), MRI and Ultrasound were done at the Emergency Room. The patient stated they found nothing on these tests. The outcome of the event low back pain was recovering and for the rest of the events was unknown.	Chronic lymphocytic leukemia (Chronic lymphocytic leukaemia, States he was diagnosed about 2 months ago.)	1381130-1	40-49 years	2021/06
331	PFIZER\BIONTECH	Kidney disorder; Absolute lymphocyte count increased; CLL progression; This is a spontaneous report from a contactable physician. An 85-year-old male patient received the second dose of BNT162B2, intramuscularly on 16Feb2021 at single dose for COVID-19 immunisation, and ibrutinib (IMBRUVICA), orally from an unspecified date to an unspecified date at 420 mg, daily, then from an unspecified date to an unspecified date at 280 mg, daily, and then from 2016 to an unspecified date at 140 mg, daily for chronic lymphocytic leukaemia (CLL). Medical history included minor environmental allergies and chronic lymphocytic leukemia. No drug abuse/illicit drug use, non-smoker, and no alcohol use. Concomitant medications included clonazepam, diphenhydramine hydrochloride (BENADRYL), iodine for supplement, zinc chloride, and quercetin. Patient previously received the first dose of BNT162B2 (COVID-19 Vaccine) on 26Jan2021 for COVID-19 immunisation. The patient experienced CLL progression in Feb2021, kidney disorder (stress on kidney) on an unspecified date, and absolute lymphocyte count increased in Feb2021. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The patient's ibrutinib dose was reduced so that he could take the minimal amount required to reduce stress on his kidney per his physician's instructions. His absolute lymphocyte count stayed stable taking ibrutinib 140 mg daily. His absolute lymphocyte count became elevated after he received his second COVID-19 vaccination. The patient saw his physician on 14May2021. The physician's opinion was that the elevated lymphocyte count was a progression of his disease. The patient asked if it was caused by the COVID-19 vaccine and the physician said it might have but he was unsure. The physician sent in a new prescription for ibrutinib 280 mg daily but the patient had not started taking it yet. The patient underwent lab tests and procedures which included absolute lymphocyte count: 3.5 ul/ml on 10Mar2021, and 5.7 ul/ml on 01May2021. The action taken in response to the events for ibrutinib was unknown. Outcome of event kidney disorder was unknown, and of other events was not resolved.  Causality for ibrutinib: The reporter's causality for the events of progression of CLL, off label dose-280 mg daily, off label dose-140 mg daily, stress on kidney and absolute lymphocyte count became elevated was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.	No current illness for this event.	1381170-1	80+ years	2021/06
332	PFIZER\BIONTECH	First dose: gas; sore arm; This is a spontaneous report received from a contactable Nurse (patient). This 70-year-old (same age at vaccination) female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, lot: EM9809) via an unspecified route of administration on 22Feb2021 at 11:30 AM in left arm as single dose to prevent Covid 19 virus. Medical history reported was parkinsons disease, chronic lymphocytic leukemia, sleep apnea, chronic fatigue, hypothyroidism, all ongoing. She has not had any changes to her medications. She has taken the same medications for years. Concomitant medication reported was immunoglobulin g human (IGG) ongoing Infusion, every 4 weeks. Patient does have a slight allergy to Miralax. She vomited when she took it. She had the Miralax in 2012 when she broke her hip, she was at a rehab hospital. The hospital didn't have any prunes, so they gave her Miralax twice. She reported she has no immunity because of her cancer, and she was hoping she can still receive the Covid 19 vaccine booster if needed. She received her IgG infusion on the days after she received her first and second Covid 19 vaccine. She's been getting IgG for 15 years. The patient experienced gas after first dose of vaccine on an unspecified date.it was reported She did fine with the first Covid 19 vaccine other than some gas. She reported she was a very young and very active. She mentioned to have maybe a sore arm on an unspecified date. The patient underwent investigations on an unspecified date included, blood work, Electromyographic Nerve Test with unspecified result and units and COVID-19 antibody test with negative result. Outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.	Chronic fatigue; Chronic lymphocytic leukemia; Hypothyroidism; Parkinson's disease; Sleep apnea	1381253-1	65-79 years	2021/06
333	PFIZER\BIONTECH	fever; chills; extreme weakness; extreme exhaustion; dizziness; sore muscles and joints; sore muscles and joints; This is a spontaneous report from a contactable consumer (Patient). A 74-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in left arm on 04Mar2021 at 09:30 (at the age of 74-years-old) as single dose for COVID-19 immunisation. Medical history included CLL Leukemia, Chronic Pancreatitis, Lymphocytic Colitis. There were no known allergies. Concomitant medication included Horizant, Progesterone, Estrogen, Levothyroxin. The patient did not receive any other vaccines within four weeks of COVID vaccine. The patient did not have COVID prior to vaccination. On 05Mar2021 at 05:00 (next day of vaccination), patient experienced fever, chills, extreme weakness, extreme exhaustion, dizziness, sore muscles and joints. No treatment was received for events. The patient was not tested for COVID post vaccination. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.	No current illness for this event.	1387570-1	65-79 years	2021/06
334	PFIZER\BIONTECH	Lack of drug effect; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included leukaemia from 2014 to an unknown date. The patient's concomitant medication includes ibrutinib (IMBRUVICA) taken for leukemia. The patient experienced lack of drug on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.	No current illness for this event.	1387744-1	Unknown	2021/06
335	PFIZER\BIONTECH	Extreme hoarseness; This is a spontaneous report from a contactable consumer (patient's child). A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on the left arm on 27Feb2021 12:00 (Batch/Lot number was not reported) at the age of 90 years old as 2nd dose, single for COVID-19 immunisation. Medical history included Chronic lymphocytic leukemia. The patient had no known allergies. Concomitant medications included vitamin B complex (VITAMIN B); omeprazole; and losartan potassium; all were reported as medications in two weeks. The patient previously had the first dose of BNT162B2, via an unspecified route of administration on the left arm on 30Jan2021 12:00 (Batch/lot number not reported) at the age of 90 years old as 1st dose, single for COVID-19 immunisation. The patient didn't have COVID prior to vaccination. The patient hadn't been tested post vaccination. On 28Feb2021 08:00 the patient experienced extreme hoarseness which resulted in doctor or other healthcare professional office/clinic visit. The patient didn't receive treatment for the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.	No current illness for this event.	1390866-1	80+ years	2021/06
336	PFIZER\BIONTECH	I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176), via an unspecified route on 03May2021 at 14:30 (at the age of 48-years) as 2nd dose, single dose in the left arm for covid-19 immunisation. The patient medical history included chronic lymphocytic leukaemia. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included rivaroxaban (XARELTO). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0151), via an unspecified route on Apr2021 at 14:30 as 1st dose, single dose in the left arm for covid-19 immunisation. On 28May2021, the patient experienced facial numbness and Paralysis. As per doctor it's bell's Palsy. The patient received treatment for events with prednisone and valacyclovir. The patient visited physician office. The outcome of the events was not recovered.  Follow-up attempts are needed. Further information is requested.	No current illness for this event.	1390990-1	40-49 years	2021/06
337	PFIZER\BIONTECH	Chronic Lymphocytic Leukemia; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included obinutuzumab (GAZYVA) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced chronic lymphocytic leukemia. The patient underwent lab tests and procedures which included antibody test: no antibodies on an unspecified date. The outcome of the event was unknown.   Information about the lot/batch number has been requested.	No current illness for this event.	1394130-1	Unknown	2021/06
338	PFIZER\BIONTECH	Has CLL, chronic lymphocytic leukemia, stage 0; She is producing very few antibodies; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. She received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient had CLL (chronic lymphocytic leukaemia stage 0) after received the both doses of the Pfizer-BioNTech COVID-19 vaccine. She explained she took antibody tests and her haematologist explained that she must act as if she had not been vaccinated. She asked if a third dose of the vaccine is recommended for immunocompromised patients. FAQ-Pfizer stated the need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. On February 25, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. Failed to explain that the study excluded participants who were immunocompromised from section ""18.1 Efficacy in Participants 16 Years of Age and Older"" of the Full EUA PI, LAB#, revised: 19May2021. She was encouraged for HCP consultation. The patient underwent lab tests and procedures which included antibody test with unknown results. The outcome of both events was unknown.""	No current illness for this event.	1398570-1	Unknown	2021/06
339	PFIZER\BIONTECH	very tired; sore arm; This is a spontaneous report from a non-contactable other healthcare professional. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: unknown) via unspecified route, as unknown, single dose on 22Mar2021 for COVID-19 immunization (at the age of 36-years). Medical history included chronic myeloid leukaemia, pancreatitis acute, Chronic Idiopathic urticaria, MALS released post op complications (bleeding), hepatic ischaemia, cholecystectomy, VATS decussation bil lungs, plurex bil lungs and ongoing idiopathic urticaria. The patient's concomitant medications were not reported. On unspecified date it was reported that patient experienced very tired & Sore arm. The clinical outcome for the event was unknown.  Follow up needed, further information has been requested.	Idiopathic urticaria	1405741-1	30-39 years	2021/06
340	PFIZER\BIONTECH	sinus headaches; Her platelets are supposed to be 150,000 to 180,000, and hers are normally 120,000. Right now they are like 30,000.; Suspect ITP; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old female patient received bnt162b2 (BNT162B2), dose 2 administered in Arm Left on 26Feb2021 (Batch/Lot Number: EL9267) at age of 67-year-old as 2ND DOSE, SINGLE for covid-19 immunisation.  Time the Vaccination Was Given Between 1100 and 1300. Vaccination Facility Type was Mass vaccination drive thru site. Medical history included she had a low platelet count before the vaccine, Seasonal allergies, Sinus headaches, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. She doesn't remember what vaccines caused her to have a sore arm, maybe tetanus, but she doesn't remember. Her maternal grandmother had leukemia which is one of the possible causes. She never had anybody else in her family with ITP or anything like that. Concomitant medications included paracetamol (TYLENOL), ibuprofen, caffeine, paracetamol (EXCEDRIN), all taken for headache.  She had both doses of the Pfizer covid 19 vaccine. The patient had her first dose of the Covid-19 Vaccine (lot: EL9269) on 05Feb2021 in her right arm and her second dose in her left arm on 26Feb2021. One of the reasons she got them in 2 different arms was because she heard she might be less likely to have arm pain. She doesn't remember what vaccines caused her to have a sore arm, maybe tetanus, but she doesn't remember. It has been years since she had another vaccine. She had enough that she actually wrote in her journal on 28Feb2021 that she was getting unusual black and blue marks all over and they were bigger than usual. It is possible it was immediately as soon as she had the second dose. She wrote on 28Feb2021, but she knows that is not the first day she noticed it. It is getting better. she still gets new ones that seem random. She has 2 marks right now on her trunk. She has one on her stomach and one on her side. She is still getting them but not as frequent or as bad. Some she knew where they were from, and others she had no recollection of hitting herself. She went to the doctor and had a regular physical and bloodwork done, and she is in the process of being diagnosed. They suspect ITP (Immune Thrombocytopenia  Purpura). The AE require a visit to Physician Office. She gets seasonal allergies, and from time to time she gets sinus headaches. She thinks she might have had some headaches at that time. She assumed they were sinus headaches because it felt like they were. During the day she took 1 Excedrin and 1 Extra Strength Tylenol for the headaches. At night she sometimes took 2 Tylenol and sometimes Ibuprofen. She does remember having some headaches. Her headaches come and go. She had them she is thinking in February or March. She still has headaches. It is normal for her year round. She had quite a few more for a while, but now it is more normal like once a week. She takes the Excedrin, Extra Strength Tylenol, and Ibuprofen as needed. She tends to go with Excedrin and Tylenol for headaches during the day if she can. At night she tends to go with Tylenol unless she took it too close to bedtime to be able to take it at night. The Tylenol is 500mg. The Excedrin is a mixture of 250mg Acetaminophen, 250mg Aspirin, and 65mg caffeine. When she took the Ibuprofen she usually took 600mg. She did have bloodwork done. Her platelets are supposed to be 150,000 to 180,000, and hers are normally 120,000. Right now they are like 30,000. They said if she notices anything weird to go to the ER. She has had several platelet tests done. The first was on 04May2021, and her platelets were 30,000. The second was on 11May2021, and her platelets were 30,000. She had it done again on 17May2021, and her platelets were 25,000. Last week she had a bone marrow scan, and she will need a bone marrow biopsy. She did have a bone marrow biopsy done at a surgery center, but no treatment. It was to rule out other possible causes. The outcome of sinus headaches was recovering, of other events was unknown.	No current illness for this event.	1405807-1	65-79 years	2021/06
341	PFIZER\BIONTECH	The heart rate was 245; A blood clot in the caller's neck; It was thought he might have lymphoma; Felt like he had a golf ball in his left arm/that little golf ball in his arm started traveling to his whole body- his back, his chest, legs, calves; Sweating; Didn't feel too great; Breathing was off/trouble breathing; Throat was hurting/sore throat; Neck was swollen; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that:  A 38-year-old male patient received first dose of BNT162B2 (Solution for injection; Lot number: ER8131 or ER8231 and Expiration date were not reported) via an unspecified route of administration, administered in left arm on 18Apr2021 (at the age of 38-year-old) as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 18Apr2021, he went to get the Covid shot through name withheld which Pfizer sponsors and it was done at name withheld. He went there and took the shot. He was told to wait 15 minutes and then left. When he got to car, immediately he felt like he had a golf ball in his left arm. The next couple of days, that little golf ball in his arm started traveling to his whole body. He felt it in his back, his chest, he felt it in his legs. Literally, in the next 3 days, he felt it literally travel through his whole body. He felt it in his calves, it was crazy also mentioned they felt sore or like ball in the arm. He started sweating and didn't feel too great. He thought it was standard side effects and didn't think much of it. A couple of days past by and then Thursday morning, he woke up and his breathing was very off. He clarifies his throat was hurting. He thought it was a sore throat and took some cough medicine and cough drops. Then the next day, it wasn't going away and was still hurting, wasn't getting any better. His breathing was very rough. If he was just standing still like laying down, then felt okay. But if went to move or do something it was very difficult. Again, expecting these symptoms, some people have said these symptoms and he didn't' think much of it. The next morning patient woke up and breathing felt fine. His neck was swollen. He thought maybe he had a sore throat or something. He was taking cough drops to soothe his throat the following day, the throat was still hurting, and it was the same. The patient called the doctor and did a telehealth. The patient told the doctor when he received the first dose Pfizer Covid Vaccine and all his symptoms. The doctor said it is a little unpredictable, nothing the doctor hasn't heard. He went to the doctor office the next day and was hooking to a nebulizer for breathing and prescribed an asthma pump. The doctor thought patient had Lymphoma in the neck. The doctor wanted to go the following day for an ultrasound. He went to the ultrasound and they checked the neck and immediately there were red flags. His heart rate was checked, and the heart rate was 245. The patient was hospitalized from 27Apr2021 to 08May2021. The minute they saw heart rate and started putting intravenous and received treatment to low down heart rate. The heart rate went down to 170 or 165. He had x-rays and a CAT scan done. He had fluids in his heart and fluid in the lung and a blood clot in neck. He had a hole cut open on left side to lungs and the lungs were drained. He went back to the ICU, they ran another CAT scan and X-ray and gave the medication. He does not know if this medication was antibiotics or what the medication was. The CDC received this information because the patient case was so rare. When the CAT scan and X-rays were run again, the fluid is right back up in the lungs. Then he was taken to surgery for the heart. An incision was cut from where itches is to back on the side, a very big incision. The heart was gone into to cut a little piece around the heart. Something was cut out so the heart could drain, and fluid could get out of the heart. While all of this is happening, he wasn't getting any better, was getting worse. The patient health deteriorated, breathing was about 10 percent and was hooked up to a breathing machine. He was sedated at that time and not awake anymore. The machine was keeping him alive. Now, every day for basically five days he was asleep and not knowing what was going on and was tested for Leukemia, cancer, and A to Z every disease you can think of to try to find common ground. Everything came back negative; nothing was wrong with the caller. He was given this or that medication every day and was sedated for about 5 days. Every day of the sedation was getting worse. He was dying and time was ticking. On the 5th day, everything was getting worse. The woman kicked everyone out of the room and went into his mouthpiece on the ventilator that was keeping the alive doing the breathing for the patient. The woman pulled something out of his lung. The woman started pumping him with steroids. What the woman took out of his lung stopped the fluid from going in. The fluid wouldn't fill back up in the lung. Once the woman started giving the steroids, the steroids killed the Pfizer Covid Vaccine. The steroids reversed the Pfizer Covid Vaccine. He was started breathing on his own again. After a couple of hours, the patient finally woke up. The patient is now recovered and has been home the past few weeks on a whole bunch of medication. He is on blood thinners, steroids, and stomach stuff. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.	No current illness for this event.	1405838-1	30-39 years	2021/06
342	PFIZER\BIONTECH	Patient presented to ED with c/o body aches, cold sweats, night sweats, coughing, weight loss, and fevers that have worsened since onset around 2 weeks ago.  Patient states his symptoms started after receiving the second Pfizer COVID-19 vaccination on 5/22/2021. Presents with fever of 101.4.  Patient was transferred to the hospital for a higher level of care. ED Diagnosis : Leukemia, acute	None documented	1407699-1	18-29 years	2021/06
343	PFIZER\BIONTECH	Acute myeloid leukemia	No current illness for this event.	1415739-1	60-64 years	2021/06
344	PFIZER\BIONTECH	Diagnosed with acute promyelocytic leukemia within 48 hours of vaccine administration. Developed fevers immediately after vaccine, thought to be appendicitis, but diagnosed with leukemia. Currently undergoing induction chemotherapy.	Leg pain, bruising	1417757-1	6-17 years	2021/06
345	PFIZER\BIONTECH	Died 5/11/2021 Causes of death listed on death certificate: 1) covid  2) chronic lymphocytic leukemia	Covid	1425840-1	80+ years	2021/06
346	PFIZER\BIONTECH	little red bumps/ hand over her wrists, you could feel the bumps; Minor rash on back of her hand and wrists; This is a spontaneous report from a contactable consumer (patient, self-reported). A 69-year-old female patient (age at vaccination: 69 year) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9262 and expiry date was not reported), via an unspecified route of administration, in Deltoid Right (upper arm), on 30Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included ongoing lymphoma and leukemia from Jul2018 and fungal lung infection, valley fever, coccidioidomycosis from Sep2020 (Stated she was still taking medicine, it can take over a year for fungus to go away, it is very recalcitrant). Concomitant medications were not reported. The patient reported that she got blood work regularly (unknown result). The patient reported that she got the COVID 19 vaccine, first one on 30Jan2021, at the (Vaccine facility name), afterwards she had a minor rash on wrists, they kept her for an hour to observe, she had no other symptoms, just the rash, it didn't itch, it was slightly on the back of her hand and wrists, and they said if she got the second dose, the reaction could be more severe, she didn't know to get it and take the risk, she was almost 70, and was cautious about being 55% protected with one dose. She talked to her doctor and was told it was up to her. She was calling to ask, it said in the handout, if you have severe allergic reactions you shouldn't, but this wasn't severe, it was mild, a localized rash on both wrists, and she wanted to get the second, she did have other health problems. She went through the clinic, it took a half hour, and she got out to the truck and was going to put on hand sanitizer but didn't, she noticed the rash on her wrists and went back in and told them, they kept her another hour, took her blood pressure, oxygen and what not, and she was fine, had no symptoms, and they said the county may not give her another vaccine, if she got the second she could have a more severe allergic reaction. She was trying to weigh the risk of being about 50% protected versus a severe reaction. There was a hospital about 3 blocks away from the clinic. The rash went away, she was fine now, she had it Saturday, Sunday, into Monday, it went away Tuesday, it was slightly up the back of her hand and both wrists, little red bumps, she didn't itch or anything, but if you ran your hand over her wrists, you could feel the bumps. Vaccine card said to get second dose by 20Feb2021, 3 weeks later. Outcome of the event minor rash on back of her hand and wrists was recovered on 02Feb2021 and for another event, it was unknown.  Follow-up attempts are completed. No further information is expected.	Leukemia; Lymphoma	1426311-1	65-79 years	2021/06
347	PFIZER\BIONTECH	increased SOB; legs much more swollen; feeling bad; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (74, units not provided) received bnt162b2 (PFIZER-BINTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 13Feb2021 as 1st dose, single for COVID-19 immunization. Medical history included multiple back surgeries in the past and leukemia, lymphoedema of legs (in treatment now). The patient's concomitant medications were not reported. The patient reported that post 1st dose of vaccine, she had pretty terrible reaction, feeling bad, wanted to go to bed, legs much more swollen and increased shortness of breath. The patient stated that shortness of breath was common for her. The patient stated that her legs always swell after surgeries. The patient stated that she heard that 2nd dose was worse for symptoms. She stated that other say it was much more painful. The patient asked if she should get the 2nd dose, or will her symptoms be worse and asked why the 2nd dose was worse/what causes it to be worse. The patient asked if she should wait to get 2nd dose so that the vaccine will decrease in her symptom to prevent side effects for the 2nd dose. The clinical outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.	Leukemia (had multiple back surgeries in the past and currently has leukemia); Lymphoedema (has lymphoedema of legs and in treatment now)	1426429-1	Unknown	2021/06
348	PFIZER\BIONTECH	81 yo male patient with a history of leukemia, diabetes, renal failure, htn, hyperlipidemia, and nephrolithiasis presents with increasing weakness over the last several days.  The patient states that he received his second pfizer covid vaccination on Monday.  Since then has felt weak and tired.  Has been short of breath with any exertion.  No fever or chills.  No chest pain.  Has had a cough when he breathes through his mouth.  He states he is only short of breath when he breathes through his mouth.  No nausea or vomiting.  Had one episode of diarrhea.  No blood in the stool or black stool.  No abdominal pain.  No urinary symptoms.  Has been eating.  Has been exposed to a known covid positive contact at home between	No current illness for this event.	1433273-1	80+ years	2021/04
349	PFIZER\BIONTECH	barely breathe; Fatigue extreme; extreme classic COPD symptoms; This is a spontaneous report received from a contactable consumer or other non hcp. A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6208) via an unspecified route of administration in Arm Right on 25Feb2021 11:45 (age at vaccination 72years old) as 1st dose, single for covid-19 immunisation. Medical history included rheumatoid arthritis from 2009 and ongoing for Rheumatoid arthritis did not take any medications for it, but does take supplements, tobacco user from an unknown date and unknown if ongoing her family smokes, so many of them have COPD; her brother and sister had lung cancer, bronchitis from Nov2020 to an unknown date. Concomitant medication(s) included magnesium (MAGNESIUM); ergocalciferol (VIT D); acetylcysteine (NAC [ACETYLCYSTEINE]) taken for an unspecified indication, start and stop date were not reported. 2 years ago, she got a pneumonia booster and a flu vaccine on the same day, both in the right arm, and her right arm did get swollen. The patient had her 1st dose on 25Feb2021 and since then she has had COPD type symptoms where she can barely breathe, but it had been intermittent. She had also had extreme fatigue, but she had been surprised by the intensity of the breathing symptoms. She had never tested positive for covid. She was a smoker. Luckily, she did have some Albuterol Sulfate with a nebulizer on hand from having acute bronchitis last Nov2020, her symptoms are like extreme classic COPD. She was wondering if the vaccine accelerated something, because she had never been diagnosed with COPD. It was intermittent and comes on suddenly, she did not ever know when it would attack her. She was also taking an Allegra-D. She did believe it was a side effect from the vaccine, she just did not know what to do especially since she did not have a primary care doctor that she can go to. It was such a dramatic response that she had not had problems with before. She was not a heavy smoker, and in fact, she was not smoking at all. She had not been smoking since experiencing these side effects because she can't breathe, and she did not want to go to the hospital at all if she did not have to. Now she was worrying about the 2nd dose, which she had been told is more intense. She was scheduled to get that on 25Mar2021. It might be that other smokers might experience these accelerated COPD symptoms. They just started since she got the vaccine. She had the vaccine on 25Feb2021 and was just a little fatigued. On 26Feb2021 and 27Feb2021, she was fine. On 28Feb2021, she was flat on her back the whole day because she was terribly congested. On 29Feb2021, she got up that morning and was reasonably okay. On 30Feb2021 and 31Feb2021, she was down the whole day and March 1st-3rd, she was fine. 04Mar2021, she was down the whole day. This day was the worst and what prompted her to call. She was afraid she would have to go to the ER because she couldn't breathe. She did a breathing treatment of the albuterol sulfate and took an Allegra D and felt like she stabilized and was feeling better today. She did not take any medications, but she did take supplements. She had Rheumatoid Arthritis, which she takes supplements for. She did not take Methotrexate because it was hard on you. Clarified that she never took Methotrexate. When she went to Rheumatoid Arthritis Clinic, a doctor there prescribed a treatment for her including Methotrexate. Before she took it she did research on it and found that she would have to have her liver enzymes tested every 2 weeks and she didn't want to be tied down to that. So, she looked into the natural alternatives to Methotrexate, and that's what she takes now. States that Methotrexate was a type of cancer drug for childhood leukemia, and it arrests the rheumatic arthritis in your joints. Supplements she takes: Omega 3 with DHA and EPA, Vitamin D 5000mg, Magnesium, NAC, and she also takes Allegra-D when she gets congested, which had been a lot recently. The patient underwent lab tests and procedures which included sars-cov-2 test: she had never tested positive for covid on unspecified date. Therapeutic measures were taken as a result of barely breathe. The clinical outcome of the event barely breathe was recovering and other events outcome was unknown.  No follow up attempts are possible. No further information is expected.	Rheumatoid arthritis (doesn't take any medications for it, but does take supplements.)	1436184-1	65-79 years	2021/06
350	PFIZER\BIONTECH	Bone pain in the pelvis and hips; Resting heart rate between 135-145 bpm for ten hours; Fever of 101 degrees; This is a spontaneous report received from a non-contactable consumer, the patient. A 46-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 13Mar2021 at 11:30 (at the age of 46-years-old) as single dose for COVID-19 immunisation. Medical history included acute myeloid leukaemia (AML), stem cell transplant, graft versus host disease (GVHD), Graves' disease and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Concomitant medications included sirolimus (MANUFACTURER UNKNOWN), sulfamethoxazole; trimethoprim (BACTRIM DS), valaciclovir (VALTREX) and levothyroxine (MANUFACTURER UNKNOWN) taken for unknown indications from unspecified dates. The patient previously received penicillin (MANUFACTURER UNKNOWN), levofloxacin (LEVOQUIN), and vancomycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 14Mar2021 at 01:30, 14 hours after the vaccination the patient experienced significant bone pain in the pelvis and hips which caused a resting heart rate between 135 to 145 beats per minute (BPM) for ten hours due to pain and fever of 101 degrees. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Therapeutic measures included intake of paracetamol (TYLENOL) during the same time frame. The patient did not receive any treatment for the event resting heart rate between 135 to 145 beats per minute (BPM). The clinical outcomes of the events bone pain in the pelvis and hips, heart rate between 135 to 145 BPM for ten hours and fever of 101 degrees were recovered on unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.	No current illness for this event.	1436223-1	40-49 years	2021/06
351	PFIZER\BIONTECH	body aches and pains; slight fever; greatly enlarged lymph node under right arm, size of an orange; 6 days later; large red swollen area on right arm; very warm to the touch and serious shoulder pain, can hardly lift arm; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6208) via unspecified route of administration in the right arm on 14Mar2021 at 13:30 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL) and fatty liver. The patient had a history of allergy to Percocet. The patient had previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL9266) via unspecified route of administration in the right arm on 21Feb2021 at 15:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient received medications (unspecified) within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021 at 16:00, the patient experienced severe body aches and pains, slight fever, greatly enlarged lymph node under right arm, which was in a size of an orange. 06 days later he had large red swollen area in the right arm, also had very warm to the touch and serious shoulder pain where he could hardly lift arm. No therapeutic measures were taken for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe body aches and pains, slight fever, greatly enlarged lymph node under right arm, large red swollen area on right arm, and very warm to the touch and serious shoulder pain, can hardly lift arm were not resolved at the time of this report.   No follow-up attempts possible. No further information expected.	No current illness for this event.	1436361-1	65-79 years	2021/06
352	PFIZER\BIONTECH	Tiredness/ tired easily; Viral infection/caught a virus; Small bowel obstruction; Dose 1 on 25Mar2021; Dose 2 on 12Apr2021; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Con-trol No. # 21K-163-3926388-00).   A non-contactable consumer (patient) reported that a 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 12Apr2021 (lot number and expiry date: unknown) at the age of 34-years-old as dose 2, single;  intramuscular on 25Mar2021 (lot number and expiry date: unknown) at the age of 34-years-old as dose 1, single, for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from Mar2019 (lot number and expiry date: unknown) to 27Apr2021, at 8571 mg (40 mg,1 in 2 wk) for Crohn's disease. Medical history included tobacco user from 2004 to May2021 , alcohol user from 2008 to an unknown date, acute myeloid leukaemia from 2017 to an unknown date, smoker, small intestine resection surgery in May2021 (Patient had an inpatient small intestine resection in May2021), and stomach spasm. The patient had a family history of acute myeloid leukemia. Concomitant medications included varenicline tartrate (CHAMPIX) to quit smoking, start and stop date were not reported; metoprolol taken for high blood pressure, start and stop date were not reported; dicyclomine taken for stomach spasm, start and stop date were not reported; venlafaxine hydrochloride (EFFEXOR) taken for antidepressant; start and stop date were not reported; and Tri-Trezisem.  The patient previously took morphine and experienced allergy.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date, the patient was tired easily (tiredness) and caught a virus (viral infection). In Jan2021, the patient experienced small bowel obstruction. The patient was told to quit smoking and was too clean without smoking. She had small intestine re-section surgery and was told not to take HUMIRA during surgery. She also had caught a virus and got over it as of 27May2021. The patient stated that she was told by her doctor that smoking was the cause of her small bowel obstruction. The patient underwent inpatient small intestine resection in May2021. The events tiredness, small bowel obstruction and viral infection/caught a virus were considered serious due to hospitalization on unspecified date, and due to other medically important condition. The patient underwent magnetic resonance imaging in Mar2021 which showed small bowel obstruction. Outcome of the events tiredness and small bowel obstruction was recovering, while for viral infection/caught a virus was recovered on 27May2021. The last action taken in response to the events for adalimumab was dose not changed.  Causality for HUMIRA (adalimumab): The reporter's causality for the events of small intestine resection, tired easily and caught a virus was not provided. The reporter's causality for the events of small bowel obstruction with HUMIRA (ADALIMUMAB) was reported as ""no reasonable possibility"". The company (AbbVie Inc.) assessed that there is no reasonable possibility that the events of small intestine re-section, tired easily and small bowel obstruction are related to HUMIRA (ADALIMUMAB). The company also assessed that there is a reasonable possibility that the event of caught a virus is related to HUMIRA (adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information, the events Tiredness, Viral infection, Small bowel obstruction are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Medical history of acute myeloid leukaemia  may provide an explanation for the event of Tiredness and Viral infection; Crohn's disease may provide an explanation for the event of Small bowel obstruction.  The case will be reassessed if additional information becomes available.""	Tobacco user	1442658-1	30-39 years	2021/07
353	PFIZER\BIONTECH	Chronic lymphatic leukaemia; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient experienced chronic lymphatic leukaemia on an unspecified date in Apr2021. The patient (caller) stated that she was diagnosed with chronic lymphatic leukaemia, and she did not have a problem in Jan, so it must had happened between Jan and Apr, that particular situation came up. Caller was wondering if the antibodies from the vaccine are compromised when you have chronic lymphatic leukaemia. Caller stated Chronic Lymphatic Leukemia, was one of those that's not really critical, with that type of leukemia you could have no problem for years and years. Caller added, but if the immune system was compromised to a point, would the antibodies from vaccine be destroyed from the chronic lymphatic leukaemia. Caller stated she could find out by being monitored with blood tests and wanted to see had the antibodies changed or not. Caller stated, she had a blood test back in Apr, and that's how they discovered she had chronic lymphatic leukaemia, at her regular doctor's office. She asked them to check for antibodies, and at that time, she did not know if she had chronic lymphatic leukaemia, she asked them to check antibodies since she was vaccinated. Caller stated they said they were good, and doctor would have the numbers, and if she had another blood test to continue checking them, and if the same, then nothing was happening, she could go that route. The patient visited the physician office for the above event. The patient underwent lab tests and procedures which included blood test: chronic lymphatic leukaemia on an unspecified date in Apr2021. Outcome of the event was reported as Unknown.   Information on the lot/batch number has been requested.	No current illness for this event.	1442662-1	Unknown	2021/07
354	PFIZER\BIONTECH	Left arm started to heat up like fire up hot sunburn hot to neck and right arm; Panic attack; Arm a bit sore; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route administration in the left arm on 24Mar2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included leukaemia (childhood in remission). The patient had no known allergies. Concomitant mediation included norethindrone; ethinyl estradiol (MICROGESTIN), esomeprazole (MANUFACTURER UNKNOWN), omega3 (MANUFACTURER UNKNOWN) and turmeric all drugs started on an unknown date for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 24Mar2021 at 12:00 (minutes after the injection), the patient's whole left arm started to heat up like fire up hot, sunburn hot. No spots no rashes were present, it continued to travel over neck to right arm which was not as severe, but also not amazing. After about 10 minutes and a panic attack later it was gone. The patient felt completely fine but reported to have had a sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events experienced. The clinical outcome of the events left arm started to heat up like fire up hot sunburn hot to neck and right arm and panic attack was resolved on 24Mar2021. The clinical outcome of the event arm a bit sore was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.	No current illness for this event.	1445924-1	40-49 years	2021/07
355	PFIZER\BIONTECH	joint pain; This is a Follow-up spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, Expiration Date: unknown), dose 2 via an unspecified route of administration on 08Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing nodal marginal zone b-cell lymphoma, neoplasm malignant and arthritis. Concomitant medication(s) included ibrutinib (IMBRUVICA) taken for neoplasm malignant; valaciclovir hydrochloride (VALTREX) taken for neoplasm malignant. Historical vaccine included BNT162B2 on 20Jan2021 for covid-19 immunization. The physician reported, he has no antibodies against Sars-CoV-2, he waited a little over a month and saw his oncologist who ran a blood test to see what antibodies he had. He has CLL (chronic lymphocytic leukemia, he is on medication for cancer (Imbruvica and Valtrex). Since he tested negative for antibodies to protect from the virus caller would like to know if possibly the vaccine gives you or helps your immunity with elevated T cells. Also, he added that he experienced joint pain causing pain at the back and knees, but did not have any adverse events such as fever, tiredness etc. after taking the vaccine and he can't identify if it is joint pain due to his arthritis or the side effects of the Covid-19 vaccine. Outcome of events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021421720 Same product and event, different patient	Small lymphocytic lymphoma (Nodal marginal zone B-cell lymphoma) (Working Formulation)	1445956-1	Unknown	2021/07
356	PFIZER\BIONTECH	102 fever; SOB; sweats; chills; This is a spontaneous report from a contactable pharmacist. A 69-year-old male patient received BNT162B2 (Solution for injection) via an unspecified route of administration, administered in arm right on 11Feb2021 at 15:45 (at the age of 69-year-old) (Lot Number: EL3302) as dose 1, single for covid-19 immunisation. Medical history included congestive heart failure (CHF) (20 years), chronic lymphocytic leukemia (CLL) (25 year) and SARS-CoV-2 test positive on 15Dec2020. Concomitant medications included apixaban (ELIQUIS), simvastatin, sacubitril valsartan sodium hydrate (ENTRESTO) and furosemide. On 12Feb2021 at 06:00, the patient experienced 102 fever, shortness of breath (sob), heart rate (hr) about 90-100, sweats and chills for last 3 days and improving slowly. It was reported that the patient was tests positive nasal swab COVID on 15Dec2020. The patient was mildly sick 2-3 weeks. She was much more fit and did not feel well for a day or two (slight fever, too, CHF and CLL, WBC of 80,000 for 25 years). It was reported that the patient did not experienced arm pain. The patient was wondering if patient need the second dose with such a strong booster reaction. Hard on his heart. The outcome of the events was not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.	No current illness for this event.	1458831-1	65-79 years	2021/07
357	PFIZER\BIONTECH	Participated in skilled therapy, continued visits w/oncologist, vaccine requested and administered, continued skilled therapy w/decrease  in strength as what brought resident to SNF w/RLE cellulits w/MRSA, Vaccine series completed, continued skilled therapy, WBCs chronically elevated per oncologist as expected may occur w/cancer tx med for active leukemia. Continued decline overall w/decline in intake of food and fluids, hospice care initiated. Over the course of months, resident declined to bedrest w/expiration 5/24/21.	UTI	1459938-1	80+ years	2021/07
358	PFIZER\BIONTECH	Wellness visit on 3/23/21 indicated platelet count of 55,000.  Previous counts were always above 150,000.  No other symptoms.  Lab work repeated and count still low.  Referred to oncologist and determined not leukemia or lupus.  Vitamin B12 very low also.   He mentioned could be one of three things, one of which was ITP.  Treatment at this time - B12 shots.  Rechecked labs in July with platelet count still low.  Will recheck again in August and see oncologist in November.  Doctors don?t indicate caused from vaccine but suspicious to me.	Afib	1464048-1	65-79 years	2021/07
359	PFIZER\BIONTECH	received a third Pfizer vaccine; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 24Jun2021 (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL) with a compromised immune system. Concomitant medication included PI3K inhibitor. The patient previously received dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. It was reported that the patient received second of two doses of the Pfizer vaccine in February. Patient since twice tested negative for the spike protein anti-body. On 24Jun2021, the patient received a third Pfizer vaccine. Outcome of the event was unknown.  Information about lot/batch number has been requested.	No current illness for this event.	1466133-1	Unknown	2021/07
360	PFIZER\BIONTECH	The adverse reaction was with my son who is breast fed not with my wife.  On June 28th we took our son  to the doctors for a normal 6 month visit and showed them some of the bruises he had on his arms caused by our daughter grabbing his arms.  They asked normal questions about any bleeding he may have had from circumcision or past shots and we told them none. They said the bruising is okay but to be careful with how our daughter plays with him.   He got his 6 month shots and we went home.  My wife noticed that he was bleeding through the bandaids and his shorts so we went back to the doctors office. They were now concerned and sent us to Hospital. Hospital did extensive blood work and ruled out things like Leukemia and things like lupus for now since his red and white blood cell count was normal. However his Platelet Count is extremely low.   They think he was experiencing ITP or Immune Thrombocytopenic Purpura. His platelet count was 5 and should be between 159-350  His body thinks he has a virus and is attacking his platelets. They treated him with immunoglobulins.    Update on Alek. A normal platelet count should be between 159-350 was 5.    The infusion of immunoglobulins he got last night worked. He got his results back and they were good news.  He increase to 132 and then 218.   The hope is that he will maintain or increase the platelet count from here on out.  He?s had a few blood tests last week and his count is very high and hopefully will level out.   My concern is this:  My wife had her 2nd Pfizer shot on June 9th. We started noticing the bruising on or around the 12th or 13th.   I?ve asked at least a dozen doctors and nurses if the virus that my son?s immune system was fighting could have been caused by my wife?s 2nd Pfizer vaccine since she breast feeds. No one can give me an answer nor will they do any testing. Not to mention my son is a COVID baby. My wife and I both had COVID while she was pregnant with him.   If anything you would think someone would care enough to at least test him for COVID or the antibodies. But no. Everyone just blows me off.   Maybe what happened to him and his case could save another little babies life. If it wasn?t for the bruising on his arms caused by my daughter who knows what could have happened. Some doctors say he could have had a brain bleed and died.	None	1467513-1	18-29 years	2021/07
361	PFIZER\BIONTECH	joint pain; headache; diarrhea; rashes all over her body and face; swollen tongue; Nausea; chills; fevers; muscle aches; sore throat; fast heartbeat; Dizzy; swelling at the injection site; the injection site had pain; the injection site had pain and swelling and was a little bit red; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6201) via an unspecified route of administration in left side of her upper arm on 04Mar2021 as dose 1 single (at the age of 74-year-old) for COVID-19 immunization.  Medical history included Psoriasis from 2005 to an unknown date, vertigo attack, immune system disorder. The caller had to see this doctor ever 4 months because of her Psoriasis. The caller usually doesn't even take the flu vaccine, normally she was in good health. Then she was diagnosed with eczema or psoriasis. Then sent to (name-held within) who thinks she may have leukemia. Methotrexate 2.5 mg one tablet by mouth every week The caller did not take this medication 2-3 weeks prior to the vaccine per her friend who is a doctor, the caller still isn't taking these medications because of the reaction. Concomitant medications were not reported. The patient took the Pfizer covid 19 injection on 04Mar2021 and the first day the injection site had pain and swelling and was a little bit red. On the second day, the swelling was there. On the third day the pain and swelling is gone. On the 4th day after the injection the caller started having fevers, muscle aches, chills, headache, joint pain, nausea, sore throat so she cannot swallow well. The caller also had a fast heartbeat and felt dizzy and cannot go out because it is dangerous. Starting yesterday, the caller found rashes all over her body and face and her fever is still there. The caller's friends did not have that many side effects and they suggested the caller call Pfizer. Last night the caller's tongue started to swell and she had pain and couldn't move her tongue or eat. The caller feels like she has been touched by an angel this morning. The caller wanted to know what can she take as a home remedy for her headache and does she need to take the second injection, the caller is going to travel. It was reported that, the caller was going to take the pain killing drug but her friends said not to do that because someone has died. The patient mentioned she had a pink face. The muscle aches stopped this morning the caller can raise her arm this morning. Every night the caller feels chills, even after drinking warm water, otherwise she was shaking. The caller feels nauseous when she gets up, she also feels dizzy when she has the nausea, she feels like she is going to have a vertigo attack. The caller has a sore throat, sometimes her voice changes, she used to not sound this bad, sometimes she cannot swallow well, she has been eating liquid things. Sometimes the caller has dizziness constantly, or when she turns or when she picks up something from the grounds, feels sometimes uneasy when she is sitting there, like she is going to faint. When the caller opened her mouth she could not put the toothbrush into her mouth because the tongue was swollen so big, pain, no blisters. On an unspecified date, patient experienced rash, diarrhea. The caller did not eat anything unusual, her friends thought it was an side effect from the injection. The caller's friends told her to report this to Pfizer because this did not happen to them. The left side of the caller's tongue is still pain, right side is swollen and painful. The caller's friend told her to put vinegar on it but she did not. Product: Second dose is scheduled for 25Mar2021. Therapeutic measures were taken as a result of rash. Prednisone for the rashes on her legs a while ago, the prednisone did not help they got worst. Unknown lot or expiration. Only took for one week and the rash didn't go away it got worse. The outcome of the events fevers, chills, sore throat, rash, nausea was not recovered muscle aches, fast heartbeat recovered on 11Mar2021, swollen tongue was recovering, outcome of the other events was unknown.  No follow up attempts are possible. No further information is expected.	No current illness for this event.	1481904-1	65-79 years	2021/07
362	PFIZER\BIONTECH	the injection arm swelled; red blotch; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 19Mar2021 at 12:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL). The patient had a history of allergy (unspecified). Concomitant medications were reported as no. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on an unspecified date in Feb2021 at 17:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Since the vaccination, patient had not been tested for COVID-19. On 25Mar2021 at 09:30, six days after vaccination the patient had experienced swelling in the injected arm and a red blotch which was not at injection site. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events the injection arm swelled and red blotches was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.	No current illness for this event.	1482049-1	60-64 years	2021/07
363	PFIZER\BIONTECH	both doses, throat tightness; This is a spontaneous report from a contactable physician. A 63-years-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot Number: FN6205) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma, environmental allergy, chronic myeloid leukemia and overactive bladder. Past drug history included fluticasone propionate, salmeterol xinafoate (ADVAIR) 100/50 twice daily inhalation taken for asthma from an unspecified start date and ongoing, azelastine hydrochloride, fluticasone propionate (DYMISTA) 1 spray each nostril twice daily taken for environmental allergy from an unspecified start date and ongoing; dasatinib monohydrate (SPRYCEL, NDC: 0003-0524-11) 70 mg, one tablet every evening taken for chronic myeloid leukaemia from 2013 to an unspecified stop date; spironolactone (SPIRONOLACTONE) 25 mg once daily taken for fluid retention from 2017 to an unspecified stop date and mirabegron (MYRBETRIQ) 50 mg once daily by mouth taken for hypertonic bladder, start and stop date were not reported. On an unspecified date, the patient experienced some throat tightness the day of the COVID vaccine that dissipated late that afternoon and that was for both doses. Caller was calling about the Pfizer BioNtech COVID vaccine. She had some throat tightness the day of the COVID vaccine that dissipated late that afternoon and that was for both doses. The outcome of the event both doses, throat tightness was recovered on an unspecified date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.	No current illness for this event.	1482273-1	60-64 years	2021/07
364	PFIZER\BIONTECH	Chronic Myeloid Leukemia; Dose Number: 1, Date of start of drug: 21Feb2021 / Dose Number: 2, Date of start of drug: 21Feb2021; This is a spontaneous report from a contactable Nurse (patient). A 61-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL9264) via an intramuscular route of administration in left arm on 21Feb2021 at 16:15 (age at vaccination 61-year-old) as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6200) via an unspecified route of administration in left arm on 21Feb2021 (age at vaccination 61-year-old) as dose 2, single for Covid-19 immunization. Patients medical history included asthma and fuchs. Patient did not have any known allergies. Patients concomitant medications included Vitamin C [Ascorbic Acid], Vitamin D3 and multivitamins (ascorbic acid, biotin, calcium, choline bitartrate, chromium, copper, folic acid, inositol, iodine, iron, magnesium, manganese, molybdenum, nicotinamide, pantothenic acid, phosphorus, potassium, pyridoxine, retinol, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos, vitamin d nos, zinc) for unspecified indication and start and stop date was not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for Covid-19.The patient had a routine CBC performed and her white blood cells (WBC) count was abnormally high, and she was diagnosed with chronic myeloid leukaemia On 29Jun2021 07:30. On 21Feb2021, patient took both doses and experienced overdose. Adverse event WBC increased and chronic myeloid leukaemia resulted into emergency room/department or urgent care. Patient was hospitalized for 4 days. Treatment included for adverse event WBC increased and chronic myeloid leukaemia was chemotherapy. The patient underwent lab tests and procedures which included full blood count: WBC count was abnormally high on jun2021, WBC count was abnormally high and was diagnosed with chronic myeloid leukaemia, since the vaccination, the patient had been tested for COVID-19. sars-cov-2 test: negative on 29Jun2021 nasal swab. The outcome of event was unknown.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event chronic myeloid leukaemia . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.	No current illness for this event.	1483427-1	60-64 years	2021/07
365	PFIZER\BIONTECH	Has had some fatigue and a mild headache but so far nothing further; Has had some fatigue and a mild headache but so far nothing further; This is a spontaneous report from a contactable consumer, the parent. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 10:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included kostmann's syndrome, acute myeloblastic leukemia, bone marrow transplant (first of its kind), did not take as quickly as hoped and was immunocompromised. The patient has not been storing antibodies for vaccines. The patient also had multiple drug allergy. The list was quite extensive from antibiotics to Dextran 40. The patient was taking multiple medications (unspecified) for post BMT (bone marrow transplant). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The reporter was not sure where to contact. The patient was compromised and a post bone marrow transplant (BMT) patient whose system did not recover quite like it should. They were iffy about giving the vaccine to the patient but his mother, the reporter insisted. He was doing great with it. Has had some fatigue and a mild headache on 01Apr2021 at 15:00, but nothing further 20 hours post shot. They said they don't have data on these patients. The reporter would keep track of any responses the patient has. Did not know if he would store the antibodies. He so far has not with any other vaccine. Therapeutic measures were taken as a result of fatigue and mild headache and included treatment with ibuprofen (MANUFACTURER UNKNOWN). The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue and mild headache was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.	No current illness for this event.	1492938-1	18-29 years	2021/07
366	PFIZER\BIONTECH	Large red swollen spot on the right cheek; Large red swollen spot on the right cheek; Tenderness; This is a spontaneous report from a contactable other hcp (Nurse). This report based on the information received by Pfizer.   A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 13Mar2021 (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on 03Apr2021 as dose 2, single for covid-19 immunisation; hyaluronic acid (RESTYLANE), via an unspecified route of administration from 14Jun2021 (Batch/Lot number was not reported) to 14Jun2021, at unspecified dose for an unspecified indication. The patient's medical history included leukaemia for 7 years and had gotten clearance from her oncologist to receive HA Fillers. The patient is currently taking multiple medications. Patient is a female that smokes daily. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced tenderness; On 15Jun2021, large red swollen spot on the right cheek. It was reported that the patient was injected on 14Jun2021 with Restylane Refyne and Restylane Defyne into her nasal labial folds and Restylane Kysse injected in her lips. On 15Jun2021 she developed a large red swollen spot on the right cheek. It was treated with ice, Tylenol, and Augmentin 875/125/ po BID for 10 days. No fever was noted. Tenderness subsided and swelling was improving. The outcome of event tenderness was recovered on an unspecified date in 2021, while outcome of event large red swollen spot on the right cheek was recovering.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.	No current illness for this event.	1493206-1	Unknown	2021/07
367	PFIZER\BIONTECH	autoimmune disorder; odd pain in her hips, lower back, lower abdomen, anterior groin; odd pain in her hips, lower back, lower abdomen, anterior groin; odd pain in her hips, lower back, lower abdomen, anterior groin; odd pain in her hips, lower back, lower abdomen, anterior groin; she had a significant reaction from the second shot, on her arm, she had a decent sized red indurated area; she had a significant reaction from the second shot, on her arm, she had a decent sized red indurated area; Chills/rigors; high fever; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK9231), dose 2 via an unspecified route of administration, administered in deltoid left on 05Jan2021 (at the age of 53-year-old) as single dose for COVID-19 immunisation. Th patient's medical history included basal cell skin cancer on her leg, diagnosed many year ago. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No family medical history. There were no concomitant medications. The patient previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730) in right deltoid on 17Dec2020 (at the age of 53-year-old) for COVID-19 immunisation. Patient received both, the first on 17Dec2020, and second 05Jan2021, and starting the beginning of Jun2021, she was having odd pain in her hips, lower back, lower abdomen, anterior groin, and she went to the doctor, this may be completely unrelated, but she was a nurse, and thought to see what if it's related, so thought to call. She did see her doctor, who ordered a ton of bloodwork, thinking this was an autoimmune disorder, so she was referred to rheumatologist, and she wanted to let Pfizer know, prior to Jun2021, she was 52, on no meds, was healthy, she had a basal cell skin cancer on her leg, but otherwise no medical issues, and this was probably unrelated, but what if it was. She didn't know a specific day when this pain started, she noticed it, at the beginning of Jun2021, she got up in the morning, and was achy, she thought it was odd, but as the day went on it improved, and then each day she started up in the morning achy, now it was to the point, she saw her doctor on 23Jun2021, and had started to become, this was interfering with her work, when she got up from seated, it was debilitating pain, almost like her legs couldn't hold her up, and she walked and it lessens, but it was horrible discomfort, she saw the doctor on 23Jun2021, who ordered autoimmune lab work, which she had done and they called her back, said it was suspicious of autoimmune disorder, some things were positive or high, and they want her to see a specialist, and she had an appointment on 27Aug2021. She didn't take meds, just with being a nurse, she worked through it, but it was to the point, she was a leukaemia nurse, inpatient, and did lifting and pulling, and when she first got up and people ask if she was ok, she was slow to walk, and she went from totally normal, had all the energy, was able to walk fast to debilitated, but it was probably a coincidence. Seriousness: She felt disabled when she first got up, it was worse, but she said to her husband, she felt disabled, but she did not think really, it was only when she was first up, then she started walking and it's better through the day, but if she sit or laid for a period of time, it was horrible; so she clarified seriousness as medically significant. Patient stated she had a significant reaction from the second shot, on her arm, she had a decent sized red indurated area, and for exactly 8 hours, had chills, rigors, high fever, which lasted 8 hours and that was it. First dose was nothing, no sore arm, no achy arm. Red indurated area happened on 07Jan2021 at 15:29PM and it went away, it was there for maybe a couple days and faded away. Stated she expected these reactions. Investigations: Stated she had to have the blood work repeated, the first time she went to the lab, they wanted her to go to a certain one, but she didn't and they didn't did run the tests properly. Labs were collected 23Jun2021, that same day, caller had labs after that, but they didn't send those, she had no additional copy. ANA titer: caller stated it said low antibody level but it's listed as high. The patient underwent lab tests and procedures which included Sjogren's Antibody: positive at 2.2, ANA screen: positive, ANA titer: critical high of 1;40 (h), SSA: negative at less than 1.0, SSB: positive at 2.2, all on 23Jun2021. The outcome of the events ""odd pain in her hips, lower back, lower abdomen, anterior groin"" and ""autoimmune disorder"" was not recovered, of the other events was recovered on an unspecified date.; Sender's Comments: Based on the available information in the case,a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events autoimmune disorder,arthralgia,backpain,groin pain and abdominal pain lower.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate""	No current illness for this event.	1497416-1	50-59 years	2021/07
368	PFIZER\BIONTECH	New-onset Chronic Lymphocytic Leukemia with severe anemia	No current illness for this event.	1505882-1	80+ years	2021/07
369	PFIZER\BIONTECH	Pericarditis; a-fib; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) via an unspecified route of administration in the left arm on 09Feb2021 as single dose for Covid-19 immunization. Medical history included chronic lymphocytic leukemia, thyroid cancer, right lobe was removed. Concomitant medications included ibrutinib (IMBRUVICA) for chronic lymphocytic leukaemia, levothyroxine sodium (LEVOXYL) for thyroid cancer, vitamins. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283) in the left arm on 19Jan2021 for Covid-19 immunization, with 0.3mg on the card. On 08Jun2021, the patient developed atrial fibrillation and pericarditis. 4 months after the second  COVID 19 vaccine, she developed pericarditis. Like the male guys get from the vaccine. She was just curious. The patient had heard that these can be side effects for young boys. She wanted to know if there's a report on atrial fibrillation and pericarditis for people belonging to her age group. At first they thought she had A-fib from one of her other pills, but they also had to pull 16oz bloody fluid off of her heart. They put her on pills for the A-fib. They think the A-Fib could be related to her other pill, but they couldn't figure out the fluid. The biopsy didn't answer the question. She was not on the medication that caused the A-fib anymore. That medication was Imbruvica for her CLL, Chronic lymphocytic leukemia. On that medication 5% of people can get A-fib. She was on it 2.5 years. Her Imbruvica was 140mg. She was no longer on it. She wanted to donate the ones she didn't use, but they wouldn't let her. Outcome of the event pericarditis was recovered in 2021, of the event a-fib was unknown.    Follow-up attempts are completed. No further information is expected.	No current illness for this event.	1509017-1	Unknown	2021/07
370	PFIZER\BIONTECH	Dizziness; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267, Expiration date: Unknown), via an unspecified route of administration in left arm on 17Feb2021 (at the age of 75-year-old) as dose 2, single for COVID prevention/ COVID-19 immunisation. The patient's medical history included chronic lymphocytic leukemia (CLL), blood pressure. Patient was diagnosed CLL about 3 years ago but stated that she was currently at a stage 0, so she was not on any medication for this, she just gets her bloodwork checked regularly for monitoring. Concomitant medications were none. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318, NDC number, Expiration date were unknown), via an unspecified route of administration in right arm on 27Jan2021 (at the age of 75-year-old) as dose 1, single for COVID-19 immunisation. It was reported that, patient was calling regarding the second dose of her COVID-19 shot. Patient stated that she has dizziness on 02Mar2021 and someone else in her building has it also. Patient had dizziness all day long. Patient stated that she went to her internist because she thought the dizziness could be her blood pressure, but that was ruled out. Patient then went to an ear, nose, and throat doctor, and he put her on some kind of steroid, and that was not the issue either, so then she was referred to a neuro ENT, and it seemed to be nothing wrong with the patient. Patient stated that she did find out that there was someone else in her building, who a few days after getting the second COVID-19 shot, had dizziness as well. Patient stated that she was unsure if he had the Pfizer version or the Moderna version. Patient stated that she did not know what Pfizer could do for her with her dizziness. She just wanted it to be on record that she had this side effect, and she would be reporting this to VAERS as well, because it should be on record. Patient stated that it seemed to be over 2000 people in the PRIVACY or world-wide that had dizziness, and so people have to realize they are not crazy when they experience that. Patient stated that some other people had to go to the ER, and went to multiple doctors and had MRIs, and all that. So, patient's concern was that she was hoping the dizziness would pass, but she wanted Pfizer to know about it, so that it could hopefully be listed as a side effect of the product. Patient was wondering if people have been reporting this side effect or not. Treatment: Patient stated that the ear doctor gave her a steroid but that did not work, so the patient was referred to a neuro ENT, and he did not see anything wrong with the patient. Patient was given two scripts for a 6-day methylprednisolone 4 mg, dose pack. Patient stated that with the first script, she took it for 5 days and then she was still dizzy, so she went back to the ENT, and he prescribed the patient another and she took all 6 days' worth of dosing for that second pack and neither got rid of her dizziness. No investigation assessment. The outcome of the event was not resolved.  Description of product complaint: Description of complaint: While providing adverse event information for the suspect product, patient stated that an ENT doctor gave her a script to help her dizziness. Patient stated that the ear doctor gave her a steroid but that did not work, so she was referred to a neuro ENT, and he did not see anything wrong with the patient. Patient was given two scripts for a 6-day methylprednisolone 4 mg, dose pack. Patient stated that with the first script, she took it for 5 days and then she was still dizzy, so she went back to the ENT, and he prescribed the patient another and she took all 6 days' worth of dosing for that second pack and neither got rid of her dizziness.   No follow-up attempts are needed. No further information is expected.	No current illness for this event.	1511675-1	65-79 years	2021/07
371	PFIZER\BIONTECH	red splotches on right arm below site; burning; red bump/tiny white bumps left leg above knee, Left torso; temperature was 1-1.2 degrees above normal; 4x7 uniformly reddish area; itchiness on right arm below site; Itchiness on left side of torso; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the right arm on 29Mar2021 at 10:00 (at the age of 68-year-old), as a single dose for COVID-19 immunisation. Medical history included low IgG, chronic lymphocytic leukemia (CLL) and the patient had a history of allergy to Neosporin slight, but bacitracin fine grass, cats and dust allergy. Concomitant medications included levetiracetam (KEPPRA) for an unknown indication from an unknown date. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the right arm on 08Mar2021 at 10:00 (at the age of 68-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 02:00 morning after, temperature was 1-1.2 degrees above normal (by afternoon, back to normal), had 6 red splotches on right arm below site and red bumps on left leg above knee. Over next two days, spread into a 4"" x 7"" uniformly reddish area, some itchiness, some burning. The patient used warm compresses, switched to cool. By day 10, spread on arm halted. Itchiness elsewhere, left side of torso, small patch. Day 11, some fading, receding on arm. On day 12, better, but still pink and uncomfortable. Left torso still small itchy area, tiny white bumps. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken for the events itchiness on right arm below site and burning with warm and cold compressors. The clinical outcome of the event temperature was above normal was recovered on 03Apr2021 while the events red splotches, ""4 x 7"" uniformly reddish area, itchiness on right arm below site, burning, red bump/tiny white bumps and itchiness on left torso were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.""	No current illness for this event.	1530827-1	65-79 years	2021/08
372	PFIZER\BIONTECH	On the indicated date, I used a stamper to add info to vax cards at the center where i was working.  I did not apply any extreme pressure to my hand, but i felt something odd.  I looked at the inside knuckle of my ring finger and there was a large ""blood blister"" (like 3/4 by 1/2 inch).  I literally thought to myself that i might have leukemia and would need to see a doctor when i return from the work trip.  A few minutes later - having switched to the other hand - I had the SAME experience.    I spoke with the public health nurse on site who suggested I report to VAERS.  I forgot until last week, I got another bleed under the same right knuckle by turning a key in a door.    I never had a prior incident like this.""	none	1541836-1	50-59 years	2021/08
373	PFIZER\BIONTECH	ED visit, Non-prescription medication, Prescription medication No significant past medical history who presents to the ED with 2-week history of fever, chills, fatigue, sweating and frontal headache.  The patient states that 4 days after getting her Covid Pfizer vaccine//2021 she started developing the symptoms on a daily basis.  The symptoms have been constant with no day/night variations. The patient has been taking Tylenol and Advil with mild improvement in symptoms.  Patient also reports some ""swelling"" at the side of her neck, but no URI symptoms or problems with swallowing.  She did report also dry cough with no CP, SOB, palp, wheezing, or hemoptysis; On presentation the patient had mild fever 37.9, heart rate 122, BP 80/52, she received 1 L bolus of Plasma-Lyte and pressure responded.  CBC showed mild hypochromic microcytic anemia Hgb 11.3, MCH 25.1, MCV 78.2, platelets 295, no leukocytosis WBC 7.4.  Her metabolic panel showed mild hyponatremia NA 132, K4.7, CR 0.9.  There was mild AST 84 and ALT 69 elevation with normal bilirubin 0.6, alk phos 241.  Lactate x2 normal.  Troponin x1 normal.  Normal coagulation panel.  Negative Covid and respiratory panel.  UA showed SG 1.020, trace ketones, protein, leukocyte Estrace, 1-5 WBC and RBC.  Blood and urine cultures were sent.  Patient was started on Vanco and Zosyn.  Chest x-ray normal. Abdominal ultrasound shows GB wall thickening 6.9 mm, negative sonographic Murphy sign. Mild hydronephrosis of right kidney.. Portal lymph node. Borderline enlarged liver 18.2 cm. Left liver cyst 2.2 x 1.6 x 2.3 cm; Extensive workup was done and patient presented with diagnosis of chronic Hepatitis B and extensive retrorperitoneal lymphadenopathy on CT abdomen. Patient followed by Infectious disease and oncology for differential diagnosis of lymphadenopathy that included infection x lymphoma/leukemia.""	No current illness for this event.	1573853-1	40-49 years	2021/08
374	PFIZER\BIONTECH	Pt developed fever and was tested for COVID which was positive.  Due to history of leukemia on chemo she was admitted to the hospital	No current illness for this event.	1578102-1	65-79 years	2021/08
375	PFIZER\BIONTECH	I did not have an adverse reaction to the vaccine, I am just trying to report a break through covid 19 infection.  Because I have CLL and was taking Imbruvica, I had heard it may have affected the vaccine's efficacy, so I joined a study with the Leukemia and Lymphoma society and found I only go 19 antibodies.  While apparently not enough to stop the infection, I never got so bad the I felt I required hospitalization.	No current illness for this event.	1586661-1	65-79 years	2021/08
376	PFIZER\BIONTECH	On July 9 I went for my general check up and my platelets were down to 67,  My GP recommended me to see a hematologist, Dr., who took some blood work ups and also recommended a bone marrow biopsy to rule out any chance of Leukemia.  The biopsy showed everything was normal with the bone marrow.  However after more blood tests my platelets this past Tuesday went down to 28 and she put me on 40mg Dexamethasome for 4 days and will take more blood this coming Monday.  I am showing no signs at all for ITP and the only thing that could've brought this on is the Covid  vaccine.  There is a possibility this could be the second occurrence for me since in March I did have bronchitis and was given prednisone for 2 weeks, so that might have made an increase in platelets without me knowing I ever had a problem until I went for my yearly checkup.  As I stated I am showing no other signs of ITP at all.  My son in law works at Facility, a local health care provider in the region and he spoke to the head hematologist there and they are also finding many cases of ITP with no underlying causes besides having the COvid vaccine.	none	1602566-1	65-79 years	2021/08
377	PFIZER\BIONTECH	I am a AML Leukemia patient. I had a Bone Marrow Transplant on 11/16/2018. My donor was a 23 year old Male. After the second vaccine, I had severe reactions. I had pericarditis, dizziness, headache, and fatigue. The pericarditis was treated and lasted about a month. The other conditions lasted 2 months. I thought that this information was important since I am an older female but had immune system of 23yr old male and the pericarditis is usually more common in young males.	None	1636421-1	50-59 years	2021/08
378	PFIZER\BIONTECH	rubbing his chest at boobs and went down to his knees. He said it was hurting bad; rubbing his chest at boobs and went down to his knees. He said it was hurting bad; has a brown oval spot at the injection site of both arms.  It is not black and blue.; has lost weight because of pain; This is a spontaneous report from a contactable consumer (Patient wife). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 at 16:30 (at the age of 66 year) as dose 2, single for COVID-19 immunisation at Hospital. Medical history included Leukemia (Diagnosed about 5 years ago). Concomitant medication(s) included ongoing nilotinib hydrochloride (TASIGNA) taken for leukaemia. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in right arm on 25Mar2021 (at the age of 66 year) for COVID-19 immunisation and experienced brown oval spot at injection site from first dose right arm. On an unspecified date in Jul2021, a week ago consumer stated that patient started rubbing his chest at boobs and went down to his knees. It was hurting bad. This has happened several times in the last 2 weeks. On an unspecified date in 2021, Patient has lost weight because of pain. They saw the doctor the other day and didn't know what to do. The doctor said he would give him some Tramadol. Patient (reporter husband) said he would get it for her (reporter) if she had pain because it doesn't do anything for him. Patient started having this pain about three weeks ago. Patient has leukemia. Patient was diagnosed prior to getting the vaccine. His numbers are going down. Patient arm was black and blue and was still there. Then clarified, on 19Apr2021 that patient has a brown oval spot at the injection site of both arms. It was not black and blue. Tramadol doesn't work for patient. The patient underwent lab tests and procedures on an unknown date in 2021 which included weight: lost weight. AE(s) require a visit to Physician Office. The outcome of event weight decrease was unknown while for rest events was not recovered.  Information about lot/batch has been requested.	No current illness for this event.	1645522-1	65-79 years	2021/08
379	PFIZER\BIONTECH	has a brown oval spot at the injection site of both arms.  It is not black and blue.; This is a spontaneous report from a contactable consumer or other non hcp (Patients wife).  A 66-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 25Mar2021 16:30 (Age at vaccination: 66-years-old) as single dose for covid-19 immunization. Vaccination Facility was Hospital. Medical history included leukaemia (Diagnosed about 5 years ago). Concomitant medication included nilotinib hydrochloride (TASIGNA) taken for leukaemia from an unspecified start date and ongoing (Started taking 4-5 years ago). Patient did not receive Additional Vaccines on Same Date of the Pfizer Suspect. Prior vaccinations within 4 weeks was reported as none. It was reported that caller is speaking on behalf of her husband. Her husband received the Pfizer vaccine. On 25Mar2021 patient experienced has a brown oval spot at the injection site of both arms. It is not black and blue. It was reported that a week ago he started rubbing his chest at boobs and went down to his knees. He said it was hurting bad. This has happened several times in the last 2 weeks. caller looked online and saw that this could be side effects. When providing weight caller adds that her husband has lost weight because of pain. They saw the doctor the other day and didn't know what to do. The doctor said he would give him some Tramadol. Her husband said he would get it for her if she had pain because it doesn't do anything for him. Caller thinks he started having this pain about three weeks ago. Adds that her husband has leukaemia. He was diagnosed prior to getting the vaccine. His numbers are going down. He received the second dose on 19Apr2021. It was given in his left arm. Caller does not have the vaccine card to provide NDC, Lot or Expiry. Caller asked if the second dose was scheduled for 26 days later after the first dose. stated that her husbands arm was black and blue and is still there. Then clarified that he has a brown oval spot at the injection site of both arms. It is not black and blue. Adverse event resulted in physician office visit. The outcome for he event was reported as not resolved at the time of this report.   Information about lot/batch has been requested.	No current illness for this event.	1645524-1	65-79 years	2021/08
380	PFIZER\BIONTECH	A little soreness; Antibodies went from zero to 1000 after receiving a third dose; Antibodies went from zero to 1000 after receiving a third dose; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Vaccine Lot Number was unknown; vaccine lot expire date was unknown), dose 3 via an unspecified route of administration, administered in the left arm on 14Jun2021 (age at vaccination was 77-year-old) as a dose 3, single for covid-19 immunisation at Pharmacy/Drug Store. The patient medical history included chronic lymphocytic leukaemia from an unknown date and unknown if ongoing Diagnosed 6 years ago; they just monitor his white blood cell count up to 60,000. He had immunodeficiency from an unknown date and unknown if ongoing He does have a Compromised immune system as far as his Chronic lymphocytic leukemia (CLL). He did have a Compromised immune system as far as his Chronic lymphocytic leukemia (CLL). There were no concomitant medications. The patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in the left arm on Jan2021 around 11am (age at the time of vaccination 76-year-old) as a dose 1, single and dose 2 via an unspecified route of administration, administered in the left arm on 05Feb2021 around 11am (at the age of 76-years-old) as a DOSE 2, SINGLE both for covid-19 immunisation at Hospital. Other Products reported as No. The reporter believed he was administered all three doses in his left arm. He had no effects, just a little soreness the next day. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) included First dose of the COVID Vaccine; Second dose of the COVID Vaccine (Lot Number / Expiry Date: Unknown). Additional Vaccines Administered on Same Date of the Pfizer Suspect considered as suspect were none. Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s) were None. The patient experienced antibodies went from zero to 1000 after receiving a third dose on 14Jun2021 and a little soreness on 15Jun2021. Patient did not have antibodies in his system after the first and second dose. The Reporter was reporting, this experience with the COVID vaccine. he reported that, first of all, he was 77 years old, and he had a condition called Chronic lymphocytic leukemia (CLL). He had his first 2 vaccines back in Jan and beginning of Feb. Then, somewhere like 4 months later, he got tested for antibodies twice, about a month apart. Both tests revealed he did not have any antibodies in his system. He states the tests and blood work were through withheld. He confirmed he did not have any antibodies. Recently, back in the beginning of Jun, he got a third vaccine. Nobody told him to do it, he just walked in and got a third shot. He got another antibody testing done after receiving the third vaccine and his antibodies went from zero to 1000. Reporter stated when he initially received the first two vaccines, he was 76 years old; he had a birthday in June and was now 77. His doctor (Oncologist/Hematologist) treated his Leukemia is separate. The reporter verified he did not have his vaccine record card with him to provide any details regarding the three doses he received.  He believed he received his second dose on 05Feb2021, so if you count back 3 weeks prior to that date, that was about the time he received his first dose. The third dose he received on 14Jun2021. The reporter believed he was administered all three doses in his left arm. He had no effects, just a little soreness the next day. He doesn't take any other medications at all. He knew he got the third dose on 14Jun2021 and wanted to wait a month or a little longer after getting the third vaccine. He didn't want to be tested right after the third shot. He got his lab work done around 26Jul2021 where his antibodies were at 1,000. He had his first 2 COVID vaccines back in Jan and beginning of Feb. Then, somewhere like 4 months later, he got tested for antibodies twice, about a month apart. Both tests revealed he did not have any antibodies in his system. Back in the beginning of Jun, he got a third vaccine. Nobody told him to do it, he just walked in and got a third shot. He got another antibody testing done after receiving the third vaccine and his antibodies went from zero to 1000. The reporter verified he does not have his vaccine record card with him to provide any details regarding the three doses he received. Antibodies test, he had the lab results, but doesn't have the dates of his test with him. The patient underwent lab tests and procedures which included sars-cov-2 antibody test that was 0 on 2021 and did not have antibodies in his system after the first dose, sars-cov-2 antibody test that was 0 on 2021 did not have antibodies in his system after the second dose, sars-cov-2 antibody test that were 1000 on 26Jul2021 antibodies went from zero to 1000 after receiving a third dose and white blood cell count that was unknown on an unspecified date. Reporter seriousness for the event was unspecified. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.	No current illness for this event.	1646058-1	65-79 years	2021/08
381	PFIZER\BIONTECH	After her vaccine she had a very confused state; Panicked; She had a UTI; Shingles; Within 2 days it looked like somebody had punched her in her face, her face was  purple on one side; shooting pain, across left cheek from her nose, her cheeks, down to her mouth; She suffered like hell for 90 days after she got her shot; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) (at the age of 88-years-old) as dose 1, single for COVID-19 immunisation. Medical history included myeloid leukaemia from 2020. It was believed that she had been diagnosed about one year previous to her getting the shot, so it could be said sometime in early 2020. Concomitant medication included ruxolitinib phosphate (JAKAFI) taken for an unspecified indication, start and stop date were not reported. On 06Feb2021, the day after the vaccine, she had a very confused state, the first which they had never seen before in her, she was panicked and was taken to the hospital and by a coincidence she had a UTI and then in the 'in room' she contracted shingles, within 2 days it looked like somebody had punched her in her face, her face was purple on one side and from that day forward for the next 90 days, she grabbed her face, at least one time every 5 minutes with the shooting pain, it would be across left cheek from her nose, her cheek and down to her mouth and she would scream out and because of her age, they didn't want to give her any pain medicine, so for 90 days she lived through that. The patient suffered like hell for 90 days after she got her shot. Patient did not recovered from 'shooting pain, across left cheek from her nose, her cheeks, down to her mouth' and 'suffered like hell' while outcome of remaining events was unknown.   Information about the lot/batch number has been requested.	No current illness for this event.	1646212-1	80+ years	2021/08
382	PFIZER\BIONTECH	complete state of confusion and disillusion; Dose 1 on 05Feb2021, doe 2 on 25Mar2021; shingles; acute reaction to the vaccine and it killed her/ the shot killed her; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25Mar2021 (at the age of 88 years old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Myeloid leukaemia from early 2020. Concomitant medication included ruxolitinib phosphate (JAKAFI) taken for myeloid leukaemia. The patient previously received the first dose of BNT162B2 on 05Feb2021 (at the age of 88 years old) for Covid-19 Immunization and experienced confused state; panicked; Urinary tract infection (UTI); shingles; within 2 days it looked like somebody had punched her in her face, her face was purple on one side; shooting pain, across left cheek from her nose, her cheeks, down to her mouth. On 25Mar2021, somebody at that recovery center thought that it was a good idea for her to go get another vaccine. And the patient also had acute myeloid leukemia (Later clarified as history) and this was known by all parties. And when she got that vaccine on 25Mar2021, she didn't even make it back to the recovery center, they took her straight to the hospital because she went in to a complete state of confusion and disillusion then. And she really never recovered and she died on 07May2021 and the reporter just want to let you all know because reporter just listened to NPR and listened to doctors try to prove some relationship between the shingles and the vaccine, and reporter was not saying shingles caused it or vice versa but she had an acute reaction to the vaccine and it killed her. For the patient's Height and Weight, Reporter stated She was 4 foot 11, she was a little bit taller but as she got older her spinal cord begin to kind of shrink up on her, so 4 foot 11 works, she was barely 100 pounds when she died. For the Reason of Death, Reporter stated Somebody decided that it was a good idea to give her second COVID vaccine, that's what killed her. If she hadn't got the second COVID vaccine, she was recovering, she was doing much better, and the reporter spoke to her on 24Mar2021, just before she got that shot and she was never the same after that, the shot killed her, reporter was not saying you all killed her, she was saying the person who said it was a good idea to give her the shot, killed the patient. The reporter was not a doctor, resisted it somebody not do that but they went ahead and did it anyway and it killed her. She suffered for 90 days after she got her shot and suffered like hell after she got her second shot. It was unknown if Autopsy was performed. The outcome of event ""acute reaction to the vaccine and it killed her/ the shot killed her"" was fatal, of the other events was unknown.  The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: acute reaction to the vaccine and it killed her/ the shot killed her""	No current illness for this event.	1646213-1	80+ years	2021/08
383	PFIZER\BIONTECH	my face began to swell; my BP went to 198/120 plus 110/196/110 plus still at 110; I was unable to breath and chocking on my own fluids in my lungs; My lungs were chocking me; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in left arm on 30Jul2021 at 14:15 (Batch/Lot Number: FA7485) as a single dose for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD), chronic myeloid leukaemia (CML) in remission and heart condition. Concomitant medications included topiramate, metoprolol and lisinopril; all taken for an unspecified indication from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19. About thirty minutes after the injection at 16:00, the patient face began to swell, and her BP went to 198/120 plus 110. Then 2 hours later she was rushed to hospital and was unable to breath and chocking on her own fluids in her lungs. She arrived at hospital unable to breathe nor catch her breath. Her lungs were chocking her, and her BP was 196/110 plus still at 110. After entering emergency room (ER) they had no clue what to do and treated her as a covid patient. She needed a nebulizer and was told the ER doctor couldn't give it to her there and no beds were available. The doctor gave her pills without explaining and then kept treating her like she came in for covid. She had the worst reaction of her life and was treated horribly. The doctor did not give her discharge paperwork, nor did hospital follow up. It was not until she went yesterday to her GP and he even said the notes were missing information, also the doctor supposedly sent me with prescriptions which she never got. She encountered, all side effects of the shot. The adverse events resulted in emergency room/department or urgent care. The outcome of the events was recovered with sequel.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose-event temporal relationship likely hypersensitivity post-vaccination  the causal role of  bnt162b2 vaccine cannot be excluded for reported events. Underlying CMLL and chronic onstructive pulmonary disease are significant risk factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate	No current illness for this event.	1646690-1	40-49 years	2021/08
384	PFIZER\BIONTECH	my arm is as red as it can be; My arm is as red as it can be, it's feverish; Still be this feverish and red and sore; Chills; Sweating; Fever of 101.6; just scratch it really bad; I have recently been diagnosed with Leukemia; cough; head congestion; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number: FA6780, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 02Aug2021 (at the age of 78-year-old) as dose 1, single for covid-19 immunization. The patient medical history included blood cholesterol, blood pressure, covid-19 and she had pacemaker. Concomitant medications included fluorometholone, ketorolac tromethamine, unspecified heart medicine, unspecified cholesterol medicine, unspecified blood pressure medicine, she taken eyedrops (two different eyedrops) all taken for unknown indications and apixaban (ELIQUIS) a blood thinner from an unknown date. It was reported that, patient got the first vaccine monday morning, her arm was as red as it could be, it's feverish, and she went this morning to show the pharmacist what it looked like and they advised her to call, because it is not normal for the five days, and still be this feverish and red and sore. She did find on Monday that she had took it but Tuesday afternoon was when she started getting feverish, chills, sweating and her ran a fever of 101.6 and then her arm started getting red and feverish (confirmed that date as 03Aug2021). She did find that on Monday, she was pleased that it did not seem like anything on Monday. She has had COVID for 8 months, she is a long hauler. She still has cough and head congestion on an unspecified date in Aug2021, she have had mini anti-biotics (Unspecified medications), nothing has helped and I have recently been diagnosed with Leukemia on an unspecified date in Aug2021 (further clarification unknown). Well, it's been maybe three weeks. No, it was a week ago this past Tuesday, she didn't remember the date was, because they needed to check to see if she has antibodies, because she has had antibodies up until now and that's why she didn't had vaccine. But they called her and told her that she no more have antibodies, and that she needed to get the vaccine, because she was getting ready for the chemotherapy on the 18th, the pill and the infusion. She didn't see an expiration date on here, she got it on 02Aug2021 (02Aug2021). There is no expiration date on here, it was scheduled for the second one at 23Aug (23Aug2021). The patient has just taken Tylenol as treatment and she have put ice pack on it. No, it kind of reduces the pain on it, she just wanted to claw it, she just wanted to get in there and just scratch it really bad on an unspecified date in Aug2021. She did take 'Xyzal' allergy medicine, she taken it every night. Tylenol helped some but it's not taking the care of the problem. The patient underwent lab tests and procedures which included antibody test: no more have antibodies on 2021, body temperature: 101.6 on 03Aug2021, Covid-19 Test: covid (that I have had COVID for 8 months) on an unspecified date. Therapeutic measures were taken as a result of her arm is as red as it can be, her arm is as red as it can be, it's feverish, still be this feverish and red and sore, chills, sweating, cough, head congestion, fever of 101.6. The outcome for events her arm is as red as it can be, her arm is as red as it can be, it's feverish, Still be this feverish and red and sore, chills, sweating, cough, head congestion, fever of 101.6 was not recovered and outcome was unknown for other events.  No follow-up attempts are possible. No further information is expected.	No current illness for this event.	1646751-1	65-79 years	2021/08
385	PFIZER\BIONTECH	Leukaemia; Type 2 diabetes mellitus; Off label use; Acute myeloid leukemia; Dyspnoea; Mental disorder; Platelet count decreased; Haemoglobin decreased; Epistaxis; Haemorrhage; White blood cell count decreased; Pneumonia; Shortness of breath; Diabetes steroid-induced; This is a non-interventional study report from an unspecified marketing program received from a contactable consumer, information received by Pfizer from agency. (Mfr. Control No.: 21K-163-3931733-00). A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 intramuscular on 16May2021 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 72-year-old) for COVID-19 immunization; venetoclax (VENCLEXTA), oral from Jun2020 (Batch/Lot Number: 1134458) to Jun2020, at 200 mg, daily, oral from Jun2020 (Batch/Lot Number: 1134458) to Mar2021, at 2 DF, daily (Take 2 tablet(s) by mouth every day (2 in 1 D)), oral from Mar2021 (Batch/Lot Number: 1134458) and ongoing, at UNK, 1x/day, oral from Jun2020 (Batch/Lot number was not reported) to Dec2020, at 200 mg, 1x/day, oral from Dec2020 (Batch/Lot number was not reported) to Jul2021, at 100 mg, 1x/day for acute myeloid leukaemia, vitamin b12 deficiency, aortic aneurysm. Medical history included type 2 diabetes mellitus, leukaemia, acute myeloid leukaemia, white blood cell count decreased, antihistamine allergy, penicillin allergy manifested by hives, unspecified abdominal pain, calculus of kidney, calculus in bladder, malignant neoplasm of prostate, unspecified urinary incontinence, male erectile dysfunction, unspecified, parkinson's disease, ileus, unspecified, familial dysautonomia, anxiety disorder, unspecified, unspecified abnormalities of gait and mobility, allergic to dye, unspecified osteoarthritis, unspecified site, essential primary hypertension, diverticulosis of intestine, part unspecified, without perforation, vitamin d deficiency, unspecified, major depressive disorder, single episode, unspecified, mastodynia, hypertrophy of breast, adverse effect of unspecified drugs, medicaments and biologics, hydroureter, dorsalgia, unspecified, acute cystitis without hematuria, calculus of ureter, thrombocytopenia, unspecified, abdominal aortic aneurysm, without rupture, deficiency of other specified b group vitamins, diabetes insipidus, alcohol user, prostate cancer, three hernia operations, intravenous contrast dye allergy manifested by breakout in hives, antiviral, antibiotic, pneumonia, unspecified urinary incontinence, penicillin allergy manifested by hives, unspecified abnormalities of mobility from an unknown date and tobacco user from an unknown date to 1987 , radical prostatectomy from 2011 to an unknown date , appendicectomy from 2013 to an unknown date. Concomitant medication(s) included azacitidine (VIDAZA) taken for acute myeloid leukaemia; aciclovir sodium (ACYCLOVIR ABBOTT VIAL) taken for antiviral treatment; levofloxacin (LEVAQUIN) taken for antibiotic therapy; metoprolol (METOPROLOL) taken for hypertension; posaconazole (POSACONAZOLE) taken for prophylaxis; allopurinol (ALLOPURINOL) taken for acute myeloid leukaemia; bicalutamide (BICALUTAMIDE) taken for prostate cancer, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for contrast media allergy, start and stop date were not reported. The patient previously took reglan [metoclopramide] and experienced sulfa [sulfacetamide sodium; sulfadiazine; sulfadimidine; sulfamerazine] and experienced drug hypersensitivity, sulfa [sulfacetamide sodium; sulfadiazine; sulfadimidine; sulfamerazine] and experienced urticaria. The past drug included antihistamine 12 hour tablet, penicillins, dye and Sulfa (Sulfonamide Antibiotics). Patient mentioned he started smoking when he was 14 years old and stopped on mid 30s, 40 years ago. Patient started drinking alcohol when he was 19 years old. Patient had three hernia operations for the past 15 years. The patient experienced pneumonia, platelet count decreased, haemoglobin decreased, epistaxis, haemorrhage, white blood cell count decreased, shortness of breath (hospitalization, medically significant) on 18May2021, type 2 diabetes mellitus, leukaemia (hospitalization, medically significant) on an unspecified date with outcome of unknown , acute myeloid leukemia, dyspnoea (hospitalization, medically significant) on 02Aug2021, mental disorder (hospitalization, medically significant) on 01Jun2021, diabetes steroid-induced (hospitalization, medically significant) on May2021, (dyspnoea) (hospitalization, medically significant) on 18May2021, off label use (hospitalization, medically significant) on an unspecified date. The patient was hospitalized for pneumonia (pneumonia) from May2021 to May2021. It was reported that On unknown dates, the patient experienced type 2 diabetes, leukaemia was getting worse, venclexta intentionally used for unlabeled indication/off label use and low white blood cell count. in May2021, the patient experienced steroid induced diabetes. on 18May2021, the patient experienced hard time breathing, low platelets, low haemoglobin, bleeding in the nose, bleeding in the arms, pneumonia and low white blood cells. On 20May2021, the low haemoglobin and bleeding in the nose resolved. On 01Jun2021, the patient experienced mind scattered. In Jul2021, the bleeding in the arms resolved. On 02Aug2021, the patient experienced shortness of breath and worsened acute myeloid leukaemia. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient was in the hospital for a couple of weeks in May2021 with pneumonia. The pneumonia mixed with leukaemia was a bad thing. The physician ordered him off of the medication for the duration of his hospital stay. His mind was scattered on 01Jun2021. He stated that developed type 2 diabetes and was supposed to resume chemo with VENCLEXTA and VIDAZA, missed dose. Two days after he received the Covid 19 vaccine he went to the emergency room. He was given two bags of platelets on 29Jul2021. The alternative etiology for the event of bleeding in the nose was reported as low haemoglobin and low white blood cells. The alternative etiology for the event of bleeding in the arms was reported as too much drugs. The alternative etiology for the event of steroid induced diabetes was reported as steroids. Primary reporter did not have the lot number information because his bottle was not the original bottle and he had the pharmacy bottle. In last May2021, Patient stated that he went to emergency room and had to hospitalized for two days. On 02Aug2021, Patient had hospitalized again due to the shortness of breath, worsened acute myeloid leukaemia and low white blood cell count. Patient stated that he was still in the hospital. Patient had a platelet transfusion yesterday due to the low white blood cell count and worsened acute myeloid leukaemia. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 16May2021 patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. The patient was treated with DAPSONE, PREDNISONE and INSULIN. On 16Jun2021, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The event of ""type 2 diabetes"" was added. On 15Jul2021, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of leukaemia was getting worse was added. On 30Jul2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, treatment drug information, laboratory/diagnostic procedures and narrative description. The events of hard time breathing, low platelets, low haemoglobin, bleeding in the nose, bleeding in the arms, low white blood cells and steroid induced diabetes were added. On 10Aug2021, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology , suspect drug information and narrative description. The events of ""shortness of breath, worsened acute myeloid leukaemia and low white blood cell count were added. Causality for Venclexta(Venetoclax): The reporter's causality for the event(s) of type 2 diabetes, venclexta intentionally used for unlabeled indication/off label use and mind scattered was not provided. the reporter's causality for the event(s) of leukemia was getting worse, hard time breathing, low platelets, low hemoglobin, bleeding in the nose, bleeding in the arms, pneumonia, low white blood cells and steroid induced diabetes with Venclexta (Venetoclax) was no reasonable possibility. Agency's opinion is that there is no reasonable possibility that the events of type 2 diabetes, leukemia was getting worse, low platelets, low hemoglobin, bleeding in the nose, bleeding in the arms, low white blood cells, venclexta intentionally used for unlabeled indication/off label use, mind scattered and steroid induced diabetes are related to Venclexta(Venetoclax). Agency's opinion is that there is a reasonable possibility that the events of hard time breathing and pneumonia are related to Venclexta (Venetoclax). The patient underwent lab tests and procedures which included haemoglobin: low on 18May2021, platelet count: low on 18May2021, ultrasound scan: pneumonia on 18May2021, ultrasound scan: pneumonia mostly cleared up on Jul2021, white blood cell count: low on 18May2021. Therapeutic measures were taken as a result of events includes two bags of platelets on 29Jul2021 and Prednisone, Insulin and Dapsone. Outcome of the events Pneumonia, dyspnoea, steroid diabetes was reported as recovering, for events acute myeloid leukemia, platelet count decreased, white blood cell count decreased it was not recovered, the events haemoglobin decreased, epistaxis, haemorrhage were recovered and unknown for events type 2 diabetes mellitus, leukaemia, mental disorder, dyspnoea and off label use.   Information about lot/batch number has been requested.; Sender's Comments: Events Pneumonia, Type 2 diabetes mellitus, Acute myeloid leukaemia, Leukaemia, Dyspnoea, Platelet count decreased, Haemoglobin decreased, Epistaxis, Haemorrhage, White blood cell count decreased, Mental disorder, Shortness of breath, Off label use most likely represent intercurrent medical conditions ( Type 2 diabetes mellitus , Leukaemia )and unrelated to bnt162b2 (COMIRNATY). Also consider effect of co-suspect drug VENETOCLAX""	No current illness for this event.	1646816-1	65-79 years	2021/08
386	PFIZER\BIONTECH	COVID-19; COVID-19; Lyme disease; Loss of teeth; Sickness; Unable to walk; Sinus disorder; Blood pressure abnormal; Infected bite; Lymphocytes raised; This is a solicited report based on the information received by Pfizer from company (Mfr. Control No.#: 21K-163-4021754-00).   A non-contactable consumer (patient) reported that a 74-year-old male patient received bnt162b2 (BNT162B2), dose 1 and dose 2; both intramuscular on unspecified dates (Batch/Lot number was not reported) as single doses for COVID-19 immunisation; ibrutinib (IMBRUVICA), oral from 30Nov2018 (Batch/Lot number was not reported) and ongoing, at 280 mg, daily for chronic lymphocytic leukemia of b-cell type not achieve remission. Medical history included chronic lymphocytic leukemia of b-cell type not achieve remission from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced COVID-19 (drug ineffective), Lyme disease, loss of teeth, sickness, unable to walk, sinus disorder, blood pressure abnormal, infected bite and lymphocytes raised on an unspecified date with outcome of not recovered. Events were described as follows: Solicited report from the country by a consumer of an elderly male with events of LOSING TEETH and SICK, LOST ABILITY TO WALK, LOT OF SINUS PROBLEMS, PRESSURE WAS KIND OF BORDERLINE, INFECTED TICK BITE, LITTLE RISE IN LYMPHOCYTES, COVID and LYME DISEASE with IMBRUVICA (IBRUTINIB). On unknown dates, the patient experienced LOSING TEETH, SICK, LOST ABILITY TO WALK, LOT OF SINUS PROBLEMS, PRESSURE WAS KIND OF BORDERLINE, INFECTED TICK BITE, LITTLE RISE IN LYMPHOCYTES, COVID and LYME DISEASE. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient reported that his pressure was kind of borderline. He had a tick bite, that looked infected, and they wanted to treat as though Lyme disease. The patient also reported that recent labs were pretty good, but there was a little rise in his lymphocytes. His oncologist thought this may be lingering effects from COVID, which he had over the winter. The patient got sick as well when he got both of his shots. He lost his ability to walk for 7-8 hours after the first dose of Pfizer vaccine, terrible headache, fever, and chills. It was just bad. The patient also experienced lot of sinus problems. He had to have his teeth extracted. The patient thought the chemotherapy had affected his teeth. The patient started losing them like a kid. He had some surgery to get all those out, and now using dentures and a partial. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures on an unspecified date which included, recent labs were pretty good,  blood pressure measurement: abnormal, lymphocyte count: increased (little rise), and COVID test: positive. The action taken in response to the events for ibrutinib was dose not changed. Events reported as other medically important condition.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the events of LOSING TEETH, SICK, LOST ABILITY TO WALK, LOT OF SINUS PROBLEMS,PRESSURE WAS KIND OF BORDERLINE, INFECTED TICK BITE, LITTLE RISE IN LYMPHOCYTES, COVID and LYME DISEASE was not provided. Company's opinion is that there is no reasonable possibility that the events of LOSING TEETH, SICK, LOST ABILITY TO WALK, INFECTED TICK BITE, LITTLE RISE IN LYMPHOCYTES, COVID and LYME DISEASE are related to IMBRUVICA(IBRUTINIB). Company's opinion is that the events of LOT OF SINUS PROBLEMS and PRESSURE WAS KIND OF BORDERLINE are not assessable.  Company's opinion is that there is no reasonable possibility that the events of LOSING TEETH, LOT OF SINUS PROBLEMS, PRESSURE WAS KIND OF BORDERLINE, LOST ABILITY TO WALK, INFECTED TICK BITE, LITTLE RISE IN LYMPHOCYTES, COVID and LYME DISEASE are related to PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN). Company's opinion is that the event SICK was not assessable.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 can be excluded for the reported event of losing teeth, lot of sinus problems, pressure was kind of borderline, lost ability to walk, infected tick bite, little rise in lymphocytes, COVID-19, Drug ineffective, sickness and lyme disease.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.	No current illness for this event.	1646817-1	65-79 years	2021/08
387	PFIZER\BIONTECH	positive for COVID; positive for covid; This is a spontaneous report from a contactable other healthcare professional. An adult male patient received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot numbers were not reported), via unspecified routes of administration on unspecified dates as single doses for COVID-19 immunization. Medical history included leukemia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient who was fully vaccinated got exposed to his wife who was not vaccinated, and he came up positive for COVID which resulted in hospitalization. The patient underwent lab tests and procedures which included COVID-19 test: positive on 09Aug2021. The events resulted in emergency room/department or urgent care visit. It was unknown if treatment was received for the events. The outcome of the events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported positive for COVID  based on the known safety profile.	No current illness for this event.	1646897-1	Unknown	2021/08
388	PFIZER\BIONTECH	leukemia advancing or progressing; leukemia advancing or progressing; white blood cells have quite taken a jumped up to 20,000; This is a spontaneous report from a Pfizer-sponsored program , received from a contactable Other-HCP via medical information team. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose 2, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said that when she went to her doctor in May2021 after having received two doses of the vaccine, her white blood cells have quite taken a jumped up to 20,000 and heard that after getting the vaccine the white blood cells can go up. Her physician told her that it might be her leukaemia advancing or progressing, but he said some people are getting their elevated white blood cell count from the Pfizer COVID vaccine. Caller was going to see her doctor again next week and wants to know if Pfizer have seen increase in white blood cells as a side effect after receiving the vaccine. Adverse events resulted into physician's office visit. The patient underwent lab test which included White Blood Cell count: white blood cells jumped up to 20,000 on an unspecified date in 2021. The outcome of events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expe; Sender's Comments: Based on the limited information provided the role of the vaccine BNT162B2 in contributing/triggering the event advancement or progression of leukemia cannot be meaningfully assessed nor excluded. The case will reassessed once information regarding patients medical history and concomitant medications are available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.	No current illness for this event.	1647374-1	Unknown	2021/08
389	PFIZER\BIONTECH	fever; headache; This is a spontaneous report received from a consumer(patient). A 56-Years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiry Date were not reported) dose 1, via on an unspecified route on 22Mar2021 as DOSE 1, SINGLE for COVID-19 Immunization (at the age of 56-Years-Old). Medical history included Leukaemia and Lymphoma on an unknown date. The concomitant medications were not reported. It was reported, is it normal to have fever of 99 degrees and headache for 2 weeks after the first Pfizer covid-19 vaccine. And asked what is the incidence of these and how long do they last and are side effects worse with the second injection and this male consumer reported receiving his first injection of the Pfizer covid-19 vaccine about two weeks ago. Ever since the injection, he had been experiencing headaches every day and fever off and on. The consumer has a history of leukaemia and lymphoma and is being treated with Imbruvica. The consumer also takes hydrocodone as well as some other unspecified medications and that he's not sure if that's part of the side effects that he is experiencing or not. Caller reported that he was told not to take Aleve, so he has been taking Tylenol for his headache and also doesn't last all day, but that most of the day he has a headache even if he takes Tylenol and also stated, he did not want to return a sample of the acetaminophen if a sample was requested that he just wanted something that worked for his pain (included Tylenol, Acetaminophen 500 mg; 100 tablets (Lot Number: ACA120055/A, Expiry date: Apr2022)). Once in a while he had a fever after receiving the Covid-19 vaccine, but the fever goes away quickly. The patient needed to reschedule second vaccine appointment for next week has a dental appointment the day before scheduled vaccine. The patient underwent lab tests and procedures which included fever of 99 degrees after first vaccine on an unspecified date. The clinical outcome of the events were unknown.     Further information needed, Information about batch/lot number has been requested.	No current illness for this event.	1648996-1	50-59 years	2021/08
390	PFIZER\BIONTECH	Soreness localised to injection site; similar to a bruise.; Soreness localised to injection site; similar to a bruise.; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 14Apr2021 at 10:45 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included acute lymphocytic leukemia (Childhood acute lymphocytic leukemia: 18 years post-diagnosis, considered cured for >10 years), seasonal allergy. The patient had no known allergies for products or food. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), and vitamins nos (MULTIVITAMIN) from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced soreness localised to injection site; similar to a bruise. It was reported that no adverse events six hours post injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events soreness localised to injection site; similar to a bruise was unknown.   No follow-up attempts are needed. No further information is expected.	No current illness for this event.	1649962-1	18-29 years	2021/08
391	PFIZER\BIONTECH	stomach ache; Diarrhea; shoulder pain; lower back pain; feeling unwell; body pain; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 13:45 as a single dose for COVID-19 immunisation. Medical history included leukemia from 2013 to 2018. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medication within two weeks prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16May2021, the patient experienced stomach ache, diarrhea, shoulder pain, lower back pain, feeling unwell and body pain. No therapeutic measures were taken as a result of the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event stomach ache, diarrhea, shoulder pain, lower back pain, feeling unwell and body pain was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.	No current illness for this event.	1651968-1	6-17 years	2021/08
392	PFIZER\BIONTECH	my neck swelled up; lumps and bumps became very hard and painful; lumps and bumps became very hard and painful; lumps and bumps became very hard and painful; This is a spontaneous report from a contactable consumer (Patient) or other non-health care professional. A 73-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9265), via an unspecified route of administration, administered in Arm Left on 27Jan2021 (Age at vaccination: 73 years) as single dose for COVID-19 immunisation.  Medical history included chronic lymphocytic leukaemia from an unknown date and unknown if ongoing. The patient previously took benadryl and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2(lot number: EL9261), administered in left arm on 27Jan2021 09:00 AM for COVID-19 immunisation. Patient received 1st dose on 27Jan2021 at 9:00 in left arm with lot number EL9261. Patient did not receive any other vaccine in four weeks. Patient received 7 prescrip-tions and 4 OTC in two weeks. Patient did not have COVID prior vaccination. Patient tested COVID post vaccination. The patient experienced my neck swelled up, lumps and bumps became very hard and painful on 18Feb2021 at 08:00. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative on 08Feb2021. Primary care doctor and oncologist waited for a while, we then tried round of Rituxan. We were trying the chemotherapy, Treanda. Lump were quite painful, and she have not felt well since 17Feb. The outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.	No current illness for this event.	1652705-1	65-79 years	2021/08
393	PFIZER\BIONTECH	Shooting pain from injection area; The pain goes down my left arm and across my chest and into my neck.; The pain goes down my left arm and across my chess and into my neck; The pain goes down my left arm and across my chess and into my neck; The pain also goes behind the shoulder; I can not lift my arm or carrying anything in my left hand; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 (at the age of 57-year-old) as dose 2, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, chronic myeloid leukaemia from an unknown date and unknown if ongoing, bronchopulmonary aspergillosis allergic from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Patient took other medications within 2 weeks prior vaccination. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EZ6199), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 02:30 PM (at the age of 57-year-old) as dose 1, single for covid-19 immunisation within four weeks from dose 2. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jun2021 07:00, the patient experienced shooting pain from injection area, the pain goes down my left arm and across my chest and into my neck, the pain also goes behind the shoulder, can not lift arm or carrying anything in left hand. It is a constant pain patient can't get rid of. Patient had tired heating pad, massages and acupuncture. Therapeutic measures were taken as a result of shooting pain from injection area, the pain goes down my left arm and across my chest and into my neck, the pain also goes behind the shoulder included aleve twice a day for the pain. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events were not recovered.   Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (30Jul2021): Follow-up attempts are completed. No further information is expected.	No current illness for this event.	1652747-1	50-59 years	2021/08
394	PFIZER\BIONTECH	Patient diagnosed with Leukemia.; Blood work done shortly (1-2 weeks) after the vaccine, showed lowered platelet count.  Previous tests had always been normal (most recent being in Nov 2020). Subsequent blood work continued to show lo; This is a spontaneous report from a Contactable consumer (patient). A 79-year-old male patient received an unknown dose of BNT162B2 via an unspecified route of administration in May2021 at the age of 79-year-old as single dose for COVID-19 immunization. Medical history included Rheumatoid arthritis. The patient did not received other vaccine in four weeks. The patient was not COVID prior vaccination. The patient did not tested COVID post vaccination. Concomitant medication was not reported. In May2021, the patient diagnosed with Leukemia, blood work done shortly (1-2 weeks) after the vaccine, showed lowered platelet count. Previous tests had always been normal (most recent being in Nov 2020). Subsequent blood work continued to show lowered platelet counts. Previous tests had always been normal (most recent being in Nov2020). Ae resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The outcome of events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.	No current illness for this event.	1655086-1	65-79 years	2021/08
395	PFIZER\BIONTECH	raised her CLL (Chronic Lymphatic Leukemia) levels; This is a spontaneous report from a Pfizer sponsored program COVAX support, received from a contactable consumer (patient) via medical information team. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included irregular heartbeat for 2 years from an unknown date. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date in 2021 for COVID-19 immunization. On an unspecified date in 2021, the patient reported that she experienced irregular heartbeat, but was told by her doctor that she has had this for 2 years. The patient also reported that she had a raised CLL (chronic lymphatic leukemia) levels. The patient underwent lab tests and procedures which included heart rate: irregular   on 2021, chronic lymphatic leukemia levels: raised on 2021. The outcome of the event was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.	No current illness for this event.	1661124-1	Unknown	2021/08
396	PFIZER\BIONTECH	swollen lymph nodes armpit; itchy skin; mild headache; mild chills; This is a spontaneous report from a contactable consumer.  A 67-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 16Feb2021 09:00 AM (at the age of 67-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Diabetes mellitus and Chronic lymphocytic leukaemia from an unknown onset and unknown ongoing and concomitant medications include Insulin Glargine (TOUJEO), Metformin, Dapagliflozin Propanediol Monohydrate (FARXIGA), Simvastatin. On 21Feb2021 06:00 AM, after the vaccination, the patient experienced swollen lymph nodes armpit, itchy skin, mild headache, mild chills. Patient received treatment with antihistamine and Tylenol. The events assessed as non-serious. No other vaccines were taken in four weeks. Patient was not found covid prior vaccination. Patient was not tested covid post vaccination. The outcome of the events was recovering at the time of this report.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (17May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.	No current illness for this event.	1661488-1	65-79 years	2021/08
397	PFIZER\BIONTECH	slight headache; light headed; heart raced; throat felt a bit constricted; diarrhea; a ringing in my left ear; My Tinnitus seems to have increased as well in both ears; Lymph nodes under arms are so big they are cutting off circulation to my arms. As big as baseballs; This is a spontaneous report from a contactable consumer (patient) or other non HCP.  A 62-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch no./Lot number and Expiration date was not reported), via an unspecified route of administration in Arm Left on 18Apr2021 at 15:00 (at the age of 62-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Chronic lymphocytic leukaemia, Known allergies: Pneumonia vaccine all from unknown date unknown if ongoing. The patient concomitant medications included Atorvastatin, fenofibrate, carvedilol, losartan all taken for unspecified indication start and stop date were not reported. patient did not received any other vaccine within four week prior to the vaccination. patient did not diagnosis covid prior and post to the vaccination. On 18Apr2021, at 15:15, 15 min after first dose, patient experienced light headed, heart raced, throat felt a bit constricted. on 18Apr2021, patient experienced a ringing in his left ear, diarrhea, his Tinnitus seems to have increased as well in both ears, Lymph nodes under arms are so big they are cutting off circulation to my arms. As big as baseballs. on 18Apr2021, 1 hr 15 min after first dose patient experienced slight headache. Adverse events resulted in Doctor or other healthcare professional office/clinic visit it was reported. patient did not received any treatment for events. it was reported that on 18Apr21 at 3:05 at (specialty pharmacy name) in left upper arm his Arm never got sore at 3:15 he had got light headed heart raced, throat felt a bit constricted, at 4:15 developed slight headache. Continued for 6 days he had diarrhea for 4 days he also have had a ringing in his left ear that was not there. his tinnitis seems to have increased as well in both ears. Lymph nodes under arms are so big they are cutting off circulation to his arms. As big as baseballs. Both arms. The outcome of events a ringing in his left ear was recovered on unspecified date in Apr2021, outcome of event his Tinnitus seems to have increased as well in both ears, Lymph nodes under arms are so big they are cutting off circulation to my arms. As big as baseballs was unknown, outcome of event slight headache recovered on 25Apr2021, outcome of event diarrhea recovered on 22Apr2021, while outcome of other events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.	No current illness for this event.	1674036-1	60-64 years	2021/09
398	PFIZER\BIONTECH	I had a 104.2 temperature/ Fever; I was in bed for 2 days Saturday and Yesterday and day before that I got it my shot on Friday, Saturday and Sunday I was in bed; Dizziness; Weakness; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; the first time had the swelling at the injection site; Last time I had lot of redness at the injection site into my arms; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (patient) reported that a patient of an unknown age and gender received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EP6955), via an unknown route of administration on an unknown date as Dose number unknown, Single for COVID-19 immunisation. The patient's medical history included chronic lymphocytic leukaemia and COVID-19 in Dec2020 to Jan 2021. Concomitant medications were not reported. On an unknown date, the patient had a 104.2 temperature/ fever; I was in bed for 2 days Saturday and Yesterday and day before that I got it my shot on Friday, Saturday and Sunday I was in bed; dizziness; weakness; injection site pain; tiredness; headache; muscle pain; chills; joint pain; the first time had the swelling at the injection site; last time I had lot of redness at the injection site into my arms; nausea; feeling unwell. The patient had a bad case of Covid for the whole month from the middle of December from the middle to the January, I was not hospitalized I just ended up in the emergency room. I had all the symptoms for 2 days and today I just feel tired and last time I was bed for 2 days and I was tired and now I was bed for 2 days. The patient confirmed that, ""I had after I got both of my Pfizer Vaccine"". The outcome of the events was unknown.  No follow-up attempts completed. No further information is expected.""	COVID-19	1674384-1	Unknown	2021/08
399	PFIZER\BIONTECH	lymphadenopathy in the left cervical/neck area; My WBC and Neutrophils are low; My WBC and Neutrophils are low; This is a spontaneous report from a contactable Nurse.   A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot Number: EL0142) via an intramuscular administered in Arm Left on 13jan2021 08:00 as single for COVID-19 immunisation. Medical history included drug hypersensitivity known allergies: PCN from an unknown date and unknown if ongoing and other medical history was none. Concomitant medications included (IBUPROFEN [IBUPROFEN SODIUM]) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot Number: EN9899) via intramuscular administered in arm right on dec2020 9:00 am as single dose for COVID-19 immunisation. On 12Feb2021 A month after receiving  2nd COVID 19 vaccine she developed lymphadenopathy in the left cervical/neck area. This has persisted to present.  WBC and Neutrophils were low and shr was seeing a Hem/Oncconcerns (as reported) about Lymphoma or Leukemia or autoimmune disease onset. Workup is pending. I wanted you to be aware of this data point being a possibility of adverse reaction. The patient underwent lab tests and procedures which included neutrophil count: low on 12Feb2021 her WBC and Neutrophils are low, white blood cell count: low on 12Feb2021 her WBC and Neutrophils are low. She had not tested for covid prior and post vaccination. The outcome of all events was not recovered.	No current illness for this event.	1677299-1	40-49 years	2021/09
400	PFIZER\BIONTECH	swollen lymph nodes under arm; extremely large swelling under arm that spread to front of chest.; large swelling also at site of shot and itchy.; large swelling also at site of shot and itchy.; This is a spontaneous report from a contactable consumer(patient) reported that. A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 09Mar2021 14:15 (Batch/Lot number was not reported) as DOSE 2 SINGLE for covid-19 immunization. The patient past Medical history included chronic lymphocytic leukemia from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) included insulin (INSULIN) taken for an unspecified indication, metformin (METFORMIN) taken for an unspecified indication, dapagliflozin propanediol monohydrate (FARXIGA) taken for an unspecified indication, simvastatin (SIMVASTATIN) taken for an unspecified indication, and acetylsalicylic acid (ASP) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On an unspecified date the patient experienced swollen lymph nodes under arm, extremely large swelling under arm that spread to front of chest and large swelling also at site of shot and itchy. No treatment was reported. The event outcome was recovering.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.	No current illness for this event.	1677772-1	65-79 years	2021/09
401	PFIZER\BIONTECH	About 2 or 3 weeks after the second does I started to break out in a rash or hives, it was itching a lot and has continued for the last 5 months. I was given an antihistamine and a course of prednisone for 6 days. After the prednisone, it started itching and breaking out again. I was given another course of prednisone of 12 days, during that time I didn't have any break outs or itching at all. I saw my hematologist, internist and dermatologist. My dermatologist diagnosed it as seborrheic dermatosis and discovered squamous cell skin cancer. I have 2 of those spots removed. I am now taking a 7-week course of prednisone and gradually as I have cut down on the dose each week, the itchy has come back gradually and small wart like out breaks have occurred. The antihistamine is taken as needed for itching; I do take more now than I did in the beginning. I will be seeing an allergist this Thursday 09/09/2021. I have been really bothered by the itching. The middle of April I was diagnosed with CLL (chronic lymphocytic leukemia). I was also given a topical steroid cream, triamcinolone acetonide.	No	1679194-1	65-79 years	2021/09
402	PFIZER\BIONTECH	Burping; her left ear was hurting; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: EW0217, Expiry date:30-Sep-2021), via an unspecified route of administration, administered in Arm Left on 27Jul2021 13:30 (at the age of 69-years-old) as dose 1, single for COVID-19 immunisation. Medical history included leukaemia , chronic kidney disease ,hypertension ,hearing aid user from an unknown date and unknown if ongoing . The patient had no known allergies. The patient's concomitant medications included Sprycel, Levothyroxine, Amlodipine, Rosuvastin, Clopidogrel, vitamin C, vitamin D. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient got the first dose on 27Jul2021 and after that her left ear was hurting and that went away. The patient experienced burping on 13Aug2021. This started about two weeks after the first shot, or 1.5 weeks something like that. She received the second dose on 17Aug2021, and her right ear started throbbing and it is constant. She stated right now she is ""so-so"" because her ear is irritating her. The caller stated she is waiting until 8 to see if she can get in to see her doctor.  She asked if this is a known side effect or if anyone has been reporting this. The caller went to urgent care on 19Aug2021 because she couldn't see her primary care provider. The caller was burping and every time she did, it caused the throbbing in her ears. The urgent care provider thought that the caller may be having acid reflux. The burping has gone away but the right ear is constantly throbbing whereas the left ear would come and go. left ear hurting. The outcome of the event burping was recovering and outcome of the other event was recovered on 21Aug2021.""	No current illness for this event.	1681857-1	65-79 years	2021/09
403	PFIZER\BIONTECH	Graft vs. Host disease, after both vaccines; This is a spontaneous report from a contactable consumer.     A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included acute myeloid leukaemia (AML) and stem cell transplant. The patient's concomitant medications were not reported.  Previously on an unknown date, the patient received the first dose of the vaccine for covid-19 immunisation.The patient experienced Graft vs. Host disease, after both vaccines on an unspecified date with outcome of unknown.  The reporter stated was trying to get the patient Rapamune/Sirolimus, she would like to secure Sirolimus for a stem cell transplant patient.The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.	No current illness for this event.	1681894-1	Unknown	2021/09
404	PFIZER\BIONTECH	mild GI upset; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse and consumer reported that a 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021(Batch/Lot number was not reported) at the age of 67-years-old as single dose for covid-19 immunisation; bosutinib (BOSULIF), via an unspecified route of administration from 26Mar2021 (Batch/Lot number was not reported, expiration date: 31Dec2023) at 400 mg, once daily for chronic myeloid leukaemia. Medical history included acute sinusitis, allergic rhinitis, anemia, chronic myeloid leukemia, cough, depression, elevated white blood cell count, gastro-esophageal reflux disease, anxiety, osteoarthrosis, fatigue, pleural effusion, postanasal drip, allergies: sulfa, doxycycline, morphine, stadolol, vytorin. Concomitant medications included atorvastatin taken for an unspecified indication, start and stop date were not reported; furosemide taken for an unspecified indication, start and stop date were not reported; montelukast taken for an unspecified indication, start and stop date were not reported; escitalopram taken for an unspecified indication, start and stop date were not reported, dasatinib monohydrate (SPRYCEL) taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant. Patient recieved covid vaccination yesterday on 25Mar2021 and the patient experienced mild GI upset this morning on 26Mar2021. The action taken in response to the event for bosutinib was unknown. The outcome of the event GI upset was unknown.  No follow-up attempts are needed. No further information is expected.	No current illness for this event.	1174359-1	65-79 years	2021/04
405	PFIZER\BIONTECH	her left side was very weak; her left arm was sore for a while which radiated to shoulder; her left arm was sore for a while which radiated to shoulder; back pains; her ears hurt on left side; hearing ringing and a loud noise which hurts the brain; hearing ringing and a loud noise which hurts the brain; hearing ringing and a loud noise which hurts the brain; heavy sweating around the neck; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 30Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included thyroid (disorder), had 2 bad strokes a few years ago, heart attack on the left side, chronic pain, bone issues, leukemia in the bone, TIA, and miniature strokes. Concomitant medication included warfarin sodium (COUMADIN). The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 for COVID-19 immunization in her right arm and it hurt a little bit. The patient also experienced coumadin level increased; she takes coumadin regularly and measured her coumadin level to be at 1.6 after getting the 1st dose. 2 weeks after, she mentioned that her level was 3 point something which was too high. The patient received her 2nd dose of the Pfizer COVID19 vaccine on 30Mar2021 on her left arm. She mentioned that her left arm was sore for a while which radiated to shoulder on 2021. It was hurting real the first night, but she mentioned that she was going to be fine and take Tylenol. She mentioned that her left arm was her dominant arm. She also had some back pains and that her ears hurt on left side and she has been hearing ringing and a loud noise which hurts the brain on 2021. She also mentioned that her left side was very weak on 2021. She takes coumadin regularly and measured her coumadin level to be at 1.6 after getting the 1st dose. 2 weeks after, she mentioned that her level was 3 point something which was too high. Upon receiving her 2nd dose, it went down to 2.4. She specifically mentioned that she did not bleed from the injection site. She also had heavy sweating around the neck last night (2021) to the point that she woke up to ""a pool of her own sweat"". She mentioned that she had the sweating in the winter times too and maybe associated with her thyroid. She is asking if these have been reported with the vaccine and if coumadin or blood thinners may interact with it. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.""	No current illness for this event.	1224492-1	Unknown	2021/04
406	PFIZER\BIONTECH	Nose bleeds/ worsened; Nose bleeds/ worsened; This is a spontaneous report from a contactable consumer (the patient). A 79-year-old male patient received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 24Feb2021 (lot number EN6198) in the right arm, and on 20Mar2021 (lot number EP7534) (unsure which arm), respectively, both via an unspecified route of administration (at the age of 79-years-old), as a single dose for COVID-19 immunization; and apixaban (ELIQUIS) film-coated tablet, oral from an unspecified date (lot number 1743875, expiration date Feb2023), at 5 mg, twice a day as blood thinner. The patient's medical history included: chronic lymphoma leukemia from 2006- he is presently MRD negative, cardiomyopathy, alcohol ablation- where they go in through the groin and shoot alcohol to shrink the size of the heart to kill the fat around the heart. There were no concomitant medications. In Feb2021, after the first dose, the patient experienced nose bleeds. The patient never had nose bleeds before until after getting the first dose and was having more since getting the second dose. He has had two in one day. He was asking if the vaccine causes nose bleeds with taking a blood thinner. The nose bleeds have been more frequent. The nose bleeds were reported as worsened. The nose bleeds did not require an emergency room or physician office visit. The action taken in response to nose bleeds/ worsened for apixaban was unknown. The outcome of nose bleeds/ worsened was not recovered.  Follow-up (26Mar2021): This is a follow up spontaneous report from a contactable consumer based on information received by Pfizer from US-BRISTOL-MYERS SQUIBB (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-031555), license party for apixaban (ELIQUIS).  This case was received via Pfizer Inc (Reference number: 2021339514) on 26-Mar-2021 and was forwarded to BMS on 30-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose Bleeds) in 79-year-old male patient who received apixaban (Eliquis) film-coated tablet (batch no. 1743875) for an unknown indication. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19 immunisation. The patient's past medical history included Chronic lymphoid leukemia (He is presently MRD negative) in 2006, Cardiomyopathy and Alcohol septal ablation (where they go in through the groin and shoot alcohol to shrink the size of the heart to kill the fat around the heart). On an unknown date, the patient started Eliquis (batch no. 1743875) (Oral), 5 milligram twice a day. On 24-Feb-2021, the patient started Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced EPISTAXIS (Nose Bleeds). The action taken with Eliquis(Oral) was unknown. At the time of the report, EPISTAXIS did not resolve. For Eliquis(Oral), the reporter did not provide any causality assessments. The reporter stated that he never had nose bleeds before until after getting the first dose and was having more since getting the second dose. He has had two in one day. He was asking if the vaccine caused nose bleeds with taking a blood thinner. The nose bleeds have been more frequent. He received he first dose on 24-Feb-2021 and the second dose on 20-Mar-2021. Event nose bleeds did not require a visit to emergency room or physician office. Relevant Tests: none.	No current illness for this event.	1245596-1	65-79 years	2021/04
407	PFIZER\BIONTECH	developed rash to the chest, head and all over the body/Rash looked like measles; Scalp was extremely itchy; dermal hypersensitivity reaction; This is spontaneous stimulated report received from a contactable health care professional. A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in right arm on 04Mar2021 (Lot Number: EN2605) as single dose for covid-19 immunisation; hydrocodone bitartrate, paracetamol (NORCO), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included gastrooesophageal reflux disease (GERD), hyperlipidaemia, chronic lymphocytic leukaemia (CLL), Degenerative joint disease (DJD). No allergies to medications, food, or other products. Concomitnat medications the patient received within 2 weeks of vaccination including amlodipine, celebrex, lipitor, omeprazole. The patient previously took first dose BNT162B2 on 11Feb2021 for covid-19 immunisation via intramuscular at left arm, developed rash on chest bilaterally on 20Feb2021. Went to dermatology, doctor gave triamcinolone for treatment. The most recent COVID-19 vaccine was administered at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Few days after second dose patient developed rash to the chest, head and all over the body. He went back to dermatology and had biopsy near his hair line. Scalp was extremely itchy, so given clobetasol. Rash looked like measles. Not on face or hands. Saw derm again on 18Mar2021, received cortisone injection with second one on 25Mar2021- first shot-4 hours of relief from itching, rash lessened temporarily and then new areas started developing. BX results (as reported): some of the features raise possibility of angiolyphoid hyperplasia with eosinophilia but favors dermal hypersensitivity reaction. No swollen lymph nodes that patient notes. Patient is extremely itchy. Taking benadryl and taking allegra during the day. Only change recently has been switching norco from 7.5/325 three times a day to 5/325 four times a day.  Wonders if the increased APAP dose caused the rash. Events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Treatment received for adverse events included pepcid, benadryl, clobesatol, allegra, Zyrtec. The event outcome for events was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events measles-like rash, itchiness, and dermal hypersensitivity with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.	No current illness for this event.	1266017-1	65-79 years	2021/04
408	PFIZER\BIONTECH	Deafness right ear; Urinary tract infection; Feeling bad; Weakness; This is a solicited report based on the information received by Pfizer.  A 85-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; ibrutinib (IMBRUVICA), oral from 02Jun2015 (Batch/Lot number was not reported) to an unspecified date, at 140 mg, 3x/day [(140 mg, 3 in 1 D)] for chronic lymphocytic leukaemia; ibrutinib (IMBRUVICA), oral from an unspecified date (Batch/Lot number was not reported) and ongoing, at 420 mg, 1x/day [420 mg (420 mg, 1 in 1 D)] for Chronic Lymphocytic Leuk of B-Cell Type Not Achieve Remis The patient had no known medical history    The patient's concomitant medications were not reported.  The patient experienced deafness right ear, urinary tract infection, feeling bad and  weakness. All events involved hospitalization and were medically significant. The patient's hospitalization was prolonged as a result of deafness right ear, urinary tract infection, feeling bad,  weakness. The action taken in response to the event(s) for ibrutinib was permanently withdrawn on an unspecified date , for ibrutinib was dose not changed. The clinical outcome of the events was recovering.  Solicited report by a consumer of an elderly male with events of couldn't hear from right ear and urinary tract infection and non-serious feel crummy and weakened with Imbruvica (Ibrutinib) and Imbruvica (Ibrutinib). There was no reported medical history.  On unknown dates, the patient experienced couldn't hear from right ear, urinary tract infection, feel crummy and weakened. Covid-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown, expiration date unknown. Patient was in hospital for a week and had lots of tests. And came out to being urinary tract infection that made him feel crummy and was weakened. Patient also reported that couldn't hear from right ear it could be from Pfizer vaccine. Which was finished a month ago. And never had much trouble with Imbruvica.  Causality for Imbruvica (Ibrutinib) The reporter's causality for the event(s) of couldn't hear from right ear, urinary tract infection, feel crummy and weakened was not provided. Company's opinion is that there is no reasonable possibility that the event of couldn't hear from right ear is related to Imbruvica (Ibrutinib). Company's opinion is that there is a reasonable possibility that the events of Urinary Tract Infection, feel crummy and weakened are related to Imbruvica (Ibrutinib).  Causality for Imbruvica (Ibrutinib) The reporter's causality for the event(s) of couldn't hear from right ear, urinary tract infection, feel crummy and weakened was not provided. Company's opinion is that there is no reasonable possibility that the event of couldn't hear from right ear is related to Imbruvica (Ibrutinib). Company's opinion is that there is a reasonable possibility that the events of Urinary Tract Infection, feel crummy and weakened are related to Imbruvica (Ibrutinib).    Suspect Drug (s):  Seq.No . : 1 Drug: Imbruvica (capsule) (Ibrutinib), Unknown Daily dose: 420 mg (140 mg, 3 in 1 D) Route of Admin:  Oral Therapy dates/Duration: 02Jun2015-Discontinued Indications for Use: Chronic Lymphocytic Leuk of B-Cell Type Not Achieve Remis  Causality Deafness right ear (Deafness unilateral)  Action(s) taken with drug: Drug discontinued Causalis per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): No reasonable possibility Dechallenge:  Unk Urinary Tract infection (Urinary Tract infection) Action(s) taken with drug:  Drug discontinued Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge:  Unk Feeling bad (Feeling abnormal) Action(s) taken with drug:  Drug discontinued Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge: Unk Weakness (Asthenia)  Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge:  Unk  Seq No.: 2 Drug: Imbruvica (Tablet) (Ibrutinib) Daily dose:  420 mg (420 mg, 1 in 1 D) Route of Admin:  Oral Therapy dates/Duration: Unk-Ongoing  indications for Use: Chronic Lymphocytic Leuk of B-Cell Type Not Achieve Remis  Causality Deafness right ear (Deafness unilateral)  Action(s) taken with drug: Dose not changed Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): No reasonable possibility Dechallenge:  N/A Urinary Tract infection (Urinary Tract infection) Action(s) taken with drug:  Dose not changed Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge:  N/A Feeling bad (Feeling abnormal) Action(s) taken with drug:  Dose not changed Causality as per reporter (Drug/Vaccine):  Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge: N/A Weakness (Asthenia)  Action(s) taken with drug: Dose not changed Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr. (Drug/Vaccine): Reasonable possibility Dechallenge: N/A  Seq No.: 3 Drug: COVID-19 Vaccine (COVID-19 Vaccine), Unknown Daily dose:  Pfizer Vaccine Route of Admin:  Intra-muscular Indications for Use: COVID-19 Vaccination  Causality Deafness right ear (Deafness unilateral)  Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine):  Reasonable possibility Dechallenge:  N/A Urinary Tract infection (Urinary Tract infection) Action(s) taken with drug:  Unknown Causality as per reporter (Drug/Vaccine):  Not Reported Dechallenge:  N/A Feeling bad (Feeling abnormal) Action(s) taken with drug:  Unknown Causality as per reporter (Drug/Vaccine):  Not Reported Dechallenge: N/A Weakness (Asthenia)  Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  The reporter assessment of the causal relationship of the events UTI, Feeling bad and Weakness  with the suspect product BNT162B2 was not provided at the time of this report.  Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information, the reported  events deafness right ear, urinary tract infection, feeling bad and  weakness are attributed to underlying or intercurrent medical conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.	No current illness for this event.	1288422-1	Unknown	2021/05
409	PFIZER\BIONTECH	Mitral valve disease; Breathing difficult; This is a solicited report based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-3759679-00). A contactable 77-year-old male consumer received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: not reported: Expiration date: not reported) dose 1 via unspecified route of administration on unspecified date as 1st dose, single for COVID-19 immunisation. The patient received Imbruvica (Ibrutinib) tablet 280mg, once in a day, orally for CLL (Chronic lymphocytic leukaemia). The patient's medical history includes Melanoma. Patient's concomitant medication includes Amlodipine Besylate 10mg for unknown indication, Aspirin (adult low dose) 81mg for unknown indication, Atenolol 100mg for unknown indication, Eliquis (Apixaban) 5mg for unknown indication, Hydrochlorothiazide 12.5mg for unknown indication, Imfinzi (Durvalumab) for unknown indication, Lasix (Furosemide) for unknown indication, Opdivo (Nivolumab) for unknown indication, Pravastatin Sodium for unknown indication on unspecified dates. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On Nov2020 patient experienced breathing difficult and mitral valve disease on unspecified date. The patient had no known allergies. Causality for Imbruvica(Ibrutinib): The reporter's causality for the event(s) of Trouble Breathing with Imbruvica(Ibrutinib) was no reasonable possibility. The reporter's causality for the event(s) of Possible Mitral Valve Issue was not provided.The outcome of all the events was unknown.  Follow-up (07May2021): Follow-up attempts completed. No further information expected. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the information available ,Vaccine BNT162B2 or comirnarity was unrelated to the events dyspnea and mitral valve disease.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.	No current illness for this event.	1332565-1	Unknown	2021/05
410	PFIZER\BIONTECH	BCR-ABL test jumped very high; This is a spontaneous report received from a contactable consumer (patient) via medical information and via Pfizer-sponsored program. An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 80 years old via an unspecified route of administration, administered in arm left on 26Jan2021 (Batch/Lot Number: CN5318) as 2nd dose, single for COVID-19 immunization and bosutinib (BOSULIF), oral from an unspecified date (Batch/Lot Number: unknown) to an unspecified date at 300 mg, 1x/day for chronic myeloid leukemia. Patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right on 05Jan2021 (Batch/Lot Number: EK4176) as 1st dose, single. Medical history included chronic myeloid leukemia. The patient's concomitant medications were not reported. Patient experienced: BCR-ABL (Philadelphia chromosome) test jumped very high on 12Apr2021 (her results went from 1.9 to 11.8). The event was considered related to the medicinal products. Seriousness criteria reported as serious. Outcome of the event was unknown. She has not had any testing since. Action taken in response to the event for bosutinib was dose not changed.	No current illness for this event.	1332682-1	80+ years	2021/05
411	PFIZER\BIONTECH	Pneumonia; This is a solicited report from a contactable consumer, based on information received by Pfizer (Mfr. Control Number: 21K-163-3826688-00), from a non-Pfizer marketing program (marketing program name not available). A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a 1st dose, single for COVID-19 immunisation and ibrutinib (IMBRUVICA), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 420 mg daily for chronic lymphocytic leukaemia.  Medical history included diabetes mellitus and allergies IV-dye, both from unknown dates. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications included apixaban (ELIQUIS); lisinopril (LISINOPRIL); loperamide hydrochloride (LOPERAMIDE HYDROCHLORIDE); pantoprazole sodium anhydrous (PANTOPRAZOLE SODIUM ANHYDROUS); tamsulosin hydrochloride (TAMSULOSIN HYDROCHLORIDE); colecalciferol (VITAMIN D3); all taken from unknown dates for unspecified indications.  On 11Mar2021 the patient experienced pneumonia. The patient was hospitalized for pneumonia from 11Mar2021 to 19Mar2021.  The action taken in response to the event for ibrutinib was temporarily withdrawn on an unspecified date. The outcome of the event pneumonia was recovering. The causality assessment for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the event pneumonia was not provided by the reporter.  The reporter's assessment of the causal relationship of the pneumonia with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.  Follow-up (18May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Based on the current available information, the event Pneumonia is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.  The case will be reassessed if additional information becomes available.	No current illness for this event.	1367053-1	Unknown	2021/06
412	PFIZER\BIONTECH	Kidney disorder; Absolute lymphocyte count increased; CLL progression; This is a spontaneous report from a contactable physician. An 85-year-old male patient received the second dose of BNT162B2, intramuscularly on 16Feb2021 at single dose for COVID-19 immunisation, and ibrutinib (IMBRUVICA), orally from an unspecified date to an unspecified date at 420 mg, daily, then from an unspecified date to an unspecified date at 280 mg, daily, and then from 2016 to an unspecified date at 140 mg, daily for chronic lymphocytic leukaemia (CLL). Medical history included minor environmental allergies and chronic lymphocytic leukemia. No drug abuse/illicit drug use, non-smoker, and no alcohol use. Concomitant medications included clonazepam, diphenhydramine hydrochloride (BENADRYL), iodine for supplement, zinc chloride, and quercetin. Patient previously received the first dose of BNT162B2 (COVID-19 Vaccine) on 26Jan2021 for COVID-19 immunisation. The patient experienced CLL progression in Feb2021, kidney disorder (stress on kidney) on an unspecified date, and absolute lymphocyte count increased in Feb2021. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The patient's ibrutinib dose was reduced so that he could take the minimal amount required to reduce stress on his kidney per his physician's instructions. His absolute lymphocyte count stayed stable taking ibrutinib 140 mg daily. His absolute lymphocyte count became elevated after he received his second COVID-19 vaccination. The patient saw his physician on 14May2021. The physician's opinion was that the elevated lymphocyte count was a progression of his disease. The patient asked if it was caused by the COVID-19 vaccine and the physician said it might have but he was unsure. The physician sent in a new prescription for ibrutinib 280 mg daily but the patient had not started taking it yet. The patient underwent lab tests and procedures which included absolute lymphocyte count: 3.5 ul/ml on 10Mar2021, and 5.7 ul/ml on 01May2021. The action taken in response to the events for ibrutinib was unknown. Outcome of event kidney disorder was unknown, and of other events was not resolved.  Causality for ibrutinib: The reporter's causality for the events of progression of CLL, off label dose-280 mg daily, off label dose-140 mg daily, stress on kidney and absolute lymphocyte count became elevated was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.	No current illness for this event.	1381170-1	80+ years	2021/06
413	PFIZER\BIONTECH	Large red swollen spot on the right cheek; Large red swollen spot on the right cheek; Tenderness; This is a spontaneous report from a contactable other hcp (Nurse). This report based on the information received by Pfizer.   A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 13Mar2021 (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on 03Apr2021 as dose 2, single for covid-19 immunisation; hyaluronic acid (RESTYLANE), via an unspecified route of administration from 14Jun2021 (Batch/Lot number was not reported) to 14Jun2021, at unspecified dose for an unspecified indication. The patient's medical history included leukaemia for 7 years and had gotten clearance from her oncologist to receive HA Fillers. The patient is currently taking multiple medications. Patient is a female that smokes daily. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced tenderness; On 15Jun2021, large red swollen spot on the right cheek. It was reported that the patient was injected on 14Jun2021 with Restylane Refyne and Restylane Defyne into her nasal labial folds and Restylane Kysse injected in her lips. On 15Jun2021 she developed a large red swollen spot on the right cheek. It was treated with ice, Tylenol, and Augmentin 875/125/ po BID for 10 days. No fever was noted. Tenderness subsided and swelling was improving. The outcome of event tenderness was recovered on an unspecified date in 2021, while outcome of event large red swollen spot on the right cheek was recovering.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.	No current illness for this event.	1493206-1	Unknown	2021/07
414	PFIZER\BIONTECH	COVID-19; COVID-19; Lyme disease; Loss of teeth; Sickness; Unable to walk; Sinus disorder; Blood pressure abnormal; Infected bite; Lymphocytes raised; This is a solicited report based on the information received by Pfizer from company (Mfr. Control No.#: 21K-163-4021754-00).   A non-contactable consumer (patient) reported that a 74-year-old male patient received bnt162b2 (BNT162B2), dose 1 and dose 2; both intramuscular on unspecified dates (Batch/Lot number was not reported) as single doses for COVID-19 immunisation; ibrutinib (IMBRUVICA), oral from 30Nov2018 (Batch/Lot number was not reported) and ongoing, at 280 mg, daily for chronic lymphocytic leukemia of b-cell type not achieve remission. Medical history included chronic lymphocytic leukemia of b-cell type not achieve remission from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced COVID-19 (drug ineffective), Lyme disease, loss of teeth, sickness, unable to walk, sinus disorder, blood pressure abnormal, infected bite and lymphocytes raised on an unspecified date with outcome of not recovered. Events were described as follows: Solicited report from the country by a consumer of an elderly male with events of LOSING TEETH and SICK, LOST ABILITY TO WALK, LOT OF SINUS PROBLEMS, PRESSURE WAS KIND OF BORDERLINE, INFECTED TICK BITE, LITTLE RISE IN LYMPHOCYTES, COVID and LYME DISEASE with IMBRUVICA (IBRUTINIB). On unknown dates, the patient experienced LOSING TEETH, SICK, LOST ABILITY TO WALK, LOT OF SINUS PROBLEMS, PRESSURE WAS KIND OF BORDERLINE, INFECTED TICK BITE, LITTLE RISE IN LYMPHOCYTES, COVID and LYME DISEASE. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient reported that his pressure was kind of borderline. He had a tick bite, that looked infected, and they wanted to treat as though Lyme disease. The patient also reported that recent labs were pretty good, but there was a little rise in his lymphocytes. His oncologist thought this may be lingering effects from COVID, which he had over the winter. The patient got sick as well when he got both of his shots. He lost his ability to walk for 7-8 hours after the first dose of Pfizer vaccine, terrible headache, fever, and chills. It was just bad. The patient also experienced lot of sinus problems. He had to have his teeth extracted. The patient thought the chemotherapy had affected his teeth. The patient started losing them like a kid. He had some surgery to get all those out, and now using dentures and a partial. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures on an unspecified date which included, recent labs were pretty good,  blood pressure measurement: abnormal, lymphocyte count: increased (little rise), and COVID test: positive. The action taken in response to the events for ibrutinib was dose not changed. Events reported as other medically important condition.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the events of LOSING TEETH, SICK, LOST ABILITY TO WALK, LOT OF SINUS PROBLEMS,PRESSURE WAS KIND OF BORDERLINE, INFECTED TICK BITE, LITTLE RISE IN LYMPHOCYTES, COVID and LYME DISEASE was not provided. Company's opinion is that there is no reasonable possibility that the events of LOSING TEETH, SICK, LOST ABILITY TO WALK, INFECTED TICK BITE, LITTLE RISE IN LYMPHOCYTES, COVID and LYME DISEASE are related to IMBRUVICA(IBRUTINIB). Company's opinion is that the events of LOT OF SINUS PROBLEMS and PRESSURE WAS KIND OF BORDERLINE are not assessable.  Company's opinion is that there is no reasonable possibility that the events of LOSING TEETH, LOT OF SINUS PROBLEMS, PRESSURE WAS KIND OF BORDERLINE, LOST ABILITY TO WALK, INFECTED TICK BITE, LITTLE RISE IN LYMPHOCYTES, COVID and LYME DISEASE are related to PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN). Company's opinion is that the event SICK was not assessable.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 can be excluded for the reported event of losing teeth, lot of sinus problems, pressure was kind of borderline, lost ability to walk, infected tick bite, little rise in lymphocytes, COVID-19, Drug ineffective, sickness and lyme disease.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.	No current illness for this event.	1646817-1	65-79 years	2021/08
415	UNKNOWN VACCINES	ADMITTED TO HOSPITAL 6/11/2021 WITH RESPIRATORY DISTRESS, SEVERE SOB EXPIRED 6/12/2021 HX. OF METASTATIC LUNG CANCER AND LEUKEMIA	No current illness for this event.	1420526-1	60-64 years	2021/06

END

[ransomnote]

Thank you for countless, glorious posts! You are such a fabulous resource!

Re Cyber Ninja's report: I see the source you quoted appears to have accidentally omitted one page. His document numbered them pages 1-6, not counting the title page, and appears to be missing page 5.

Another source I found numbered them pages 1-6 and then only had 5 pages?!

Anyway, this looks like the text of page 5 ( HTML below). I don't have time right now to find a better source.

This posted out on an old Q thread. I hope you find your way back to the forum safely! :D

<p><img src="https://i.imgur.com/KGJhR88.png" /></p>
<p><img src="https://i.imgur.com/OPAiQLs.png" /></p>