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Q ~ Trust Trump's Plan ~ 09/08/21 Vol.369, Q Day 1412
qalerts.net ^ | 9/8/2021 | FReeQs, FReepers, and vanity

Posted on 09/08/2021 8:29:03 PM PDT by ransomnote

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To: Oorang

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


2,021 posted on 09/13/2021 11:03:22 PM PDT by bitt (<img src=' 'width=50%>)
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To: Oorang

@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.


2,022 posted on 09/13/2021 11:07:25 PM PDT by bitt (<img src=' 'width=50%>)
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To: All

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

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


2,023 posted on 09/14/2021 3:14:41 AM PDT by nclaurel (Twice denied my “basic human rights” by being Double Banned by Twitter Communists)
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To: smileyface
"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. 0-02-01-e66ea200fd55ae23de494bc154c4b84fb1c7b9bc869ff6f8848434a294d7846c-b73a1961159f2db4
2,024 posted on 09/14/2021 4:57:37 AM PDT by MomwithHope (Forever grateful to all our patriots, past, present and future. )
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To: RitaOK

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. :-)


2,025 posted on 09/14/2021 6:16:43 AM PDT by AFB-XYZ (Stand up, or bend over)
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To: sevlex

Servlex Good to know!


2,026 posted on 09/14/2021 7:11:37 AM PDT by Pete from Shawnee Mission ( )
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Comment #2,027 Removed by Moderator

To: LittleLinda; gymbeau

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.


2,028 posted on 09/14/2021 9:01:57 AM PDT by AZLiberty (Awaiting the return of the king -- and I don't mean Elvis.)
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To: AZLiberty

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


2,029 posted on 09/14/2021 10:54:38 AM PDT by gymbeau (I refuse to be anonymous. I am THEnonymous.)
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To: Oorang
“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.”

2,030 posted on 09/14/2021 11:16:59 AM PDT by AZLiberty (Awaiting the return of the king -- and I don't mean Elvis.)
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To: mbrfl
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.

2,031 posted on 09/14/2021 5:06:31 PM PDT by numberonepal (WWG1WGA)
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To: ransomnote

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


2,032 posted on 09/14/2021 6:14:33 PM PDT by Axenolith (WOOT! Another day without False Vacuum Decay!!!)
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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

2,033 posted on 09/15/2021 4:44:56 PM PDT by ransomnote (IN GOD WE TRUST)
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To: Melian

“ 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


2,034 posted on 09/15/2021 7:17:01 PM PDT by EasySt (Say not this is the truth, but so it seems to me to be, as I see this thing I think I see #KAG.)
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To: EasySt

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


2,035 posted on 09/15/2021 9:45:42 PM PDT by Melian (The more you tighten your grip, the more star systems will slip through your fingers.)
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To: ransomnote

BKMK


2,036 posted on 09/17/2021 7:31:08 PM PDT by Faith65 (Isaiah 40:31 )
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To: Ymani Cricket
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

JANSSEN18
MODERNA187
PFIZER\BIONTECH209
UNKNOWN VACCINES1

 

RowVaccine ManufacturerAdverse Event DescriptionCurrent
Illness
VAERS IDAgeMonth
Reported
1JANSSENStarted 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 Leukemia1187744-165-79 years2021/04
2JANSSENTREMORS 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 disorder1189466-165-79 years2021/04
3JANSSENFEVER; 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.Asthma1253163-1Unknown2021/03
4JANSSENDIARRHEA; 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.Leukemia1253294-1Unknown2021/03
5JANSSENNEUROENDOCRIME 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.1261314-160-64 years2021/04
6JANSSENBURNING 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.)1261342-150-59 years2021/04
7JANSSENTOE 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 month1262094-1Unknown2021/04
8JANSSENNEGATIVE 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.1269174-1Unknown2021/04
9JANSSENPatient 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)1274327-150-59 years2021/04
10JANSSENDULL 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 allergy1366821-180+ years2021/06
11JANSSENCHRONIC 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).Fatigue1390698-160-64 years2021/06
12JANSSENACHY 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 leukemia1463885-1Unknown2021/07
13JANSSENABNORMAL 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 mellitus1485946-150-59 years2021/07
14JANSSENapproximately 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 leukemianone1523657-160-64 years2021/08
15JANSSENFatigue and trouble breathing.  Blood tests led to diagnosis of Acute B Lymphoblastic leukemia. Current treatment is aggressive chemotherapy. Blood transfusionsNo current illness for this event.1558249-130-39 years2021/08
16JANSSENACUTE 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.1677101-1Unknown2021/09
17JANSSENHospitalized;  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)1678858-118-29 years2021/09
18JanssenNEUROENDOCRIME 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.1261314-160-64 years2021/04
19MODERNAPatient 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.Strep0936993-140-49 years2021/01
20MODERNAAcute 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 home0980352-180+ years2021/01
21MODERNAI 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 vaccination1017765-165-79 years2021/02
22MODERNAPt 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, SCC1039221-165-79 years2021/02
23MODERNADeveloped 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.1048914-160-64 years2021/02
24MODERNAPatient 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.1064080-165-79 years2021/03
25MODERNA2/28/21 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.1065546-180+ years2021/03
26MODERNAI 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 dayNo current illness for this event.1098845-165-79 years2021/03
27MODERNAHer 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.1107179-180+ years2021/03
28MODERNATired; 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)1107189-1Unknown2021/03
29MODERNADeveloped leukemia and kidney failure. Died in 6 days.No current illness for this event.1107648-180+ years2021/03
30MODERNAhad 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.1129674-165-79 years2021/03
31MODERNAplates 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.Leukemia1129726-165-79 years2021/03
32MODERNAPatient 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 survivor1134379-118-29 years2021/03
33MODERNAPatient 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)1134671-180+ years2021/03
34MODERNADiagnosis 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 caseNo current illness for this event.1135307-180+ years2021/03
35MODERNAAbnormal CT of the abdomen Anemia due to GI blood loss CLL (chronic lymphocytic leukemia) (CMS/HCC) Abnormal EKG  Macrocytosis Anemia requiring transfusions Symptomatic anemiaNo current illness for this event.1145392-180+ years2021/03
36MODERNAmild 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.Leukemia1149901-165-79 years2021/03
37MODERNAPatient 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 failure1170447-180+ years2021/04
38MODERNATired; 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.Leukemia1173592-1Unknown2021/04
39MODERNAstroke; 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)1188859-165-79 years2021/04
40MODERNADeep 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 requestedChronic lymphocytic leukemia; Depression; Drug allergy (allergic reaction to Rituxan.); Glaucoma1189625-165-79 years2021/04
41MODERNACovid 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.1206921-165-79 years2021/04
42MODERNAPt 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.1209570-118-29 years2021/04
43MODERNADeath 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.1213285-180+ years2021/04
44MODERNAPatient 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 4/7/2021depression, hyperlipidemia1216264-180+ years2021/04
45MODERNAelevated 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.1220867-160-64 years2021/04
46MODERNAPneumonia; 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 excludedNo current illness for this event.1235518-1Unknown2021/04
47MODERNAPneumonia; 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 impaired1241376-180+ years2021/04
48MODERNA1/5 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/a1243466-180+ years2021/04
49MODERNATested 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.1249662-1Unknown2021/04
50MODERNAMass 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)1261547-165-79 years2021/04
51MODERNASince 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 longNo current illness for this event.1289956-160-64 years2021/05
52MODERNAHyponatremia; 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.1294096-1Unknown2021/05
53MODERNADecreased 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 leukemia1298894-165-79 years2021/05
54MODERNAPatient 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.1300022-160-64 years2021/05
55MODERNAfluid 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 cofounderAllergic reaction to drug; Allergy to chemicals; Blood pressure high; Chronic lymphocytic leukemia; Fatigue; Fruit allergy (Cantaloupes); Swelling; Swollen lymph nodes1301804-180+ years2021/05
56MODERNA4/28 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 clindamycin1302850-150-59 years2021/05
57MODERNAVaccination 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.1309305-165-79 years2021/05
58MODERNAhallucinating; 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 describedChronic lymphocytic leukemia1312881-165-79 years2021/05
59MODERNAED 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 MDNo current illness for this event.1313931-165-79 years2021/05
60MODERNAModerna 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 nerve1327760-165-79 years2021/05
61MODERNADetached 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 cancer1334854-165-79 years2021/05
62MODERNACOVID-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.1345838-165-79 years2021/05
63MODERNA71 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, 2021See chronic/long standing conditions1354838-165-79 years2021/05
64MODERNAPatient 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 mother1355782-118-29 years2021/05
65MODERNAdiagnosed 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.1359985-165-79 years2021/05
66MODERNAAdmit 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 homeNo current illness for this event.1368493-160-64 years2021/06
67MODERNATuesday 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.1371656-180+ years2021/06
68MODERNACMML 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 leukemia1375714-1Unknown2021/06
69MODERNAneuropathy; 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.1380709-150-59 years2021/06
70MODERNAExperienced 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.1392407-165-79 years2021/06
71MODERNASaddle 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 lymphoma1401708-160-64 years2021/06
72MODERNAI experience face and ear swollen. Couldn't chew. Since vaccination I been diagnosis with A-Fib and Lymphocytic Leukemia.No.1406711-165-79 years2021/06
73MODERNALeukemia diagnosed April 2021 after ~1 mo of fatigue, bruisingnone1418096-150-59 years2021/06
74MODERNAPt 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.None1425042-165-79 years2021/06
75MODERNAPancreatitis; 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 leukemia1435903-160-64 years2021/06
76MODERNAOn 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.none1437986-150-59 years2021/06
77MODERNAMy 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 elbow1446639-160-64 years2021/07
78MODERNAPt 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.None1459400-150-59 years2021/07
79MODERNAAcute 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.1465095-140-49 years2021/07
80MODERNAAfter 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!!None1467508-165-79 years2021/07
81MODERNAIt'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"".)""1481719-150-59 years2021/07
82MODERNALow 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 leukemia1481773-140-49 years2021/07
83MODERNApatient reports that she started with reactivation of cancer symptoms (Chronic lymphocytic leukemia ) after Moderna Covid vaccineUNKNOWN1485034-165-79 years2021/07
84MODERNAWithin 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.1485987-180+ years2021/07
85MODERNApatient says after her 2 shot covid 19 vaccine series her leukemia numbers went up and have since come back down.CML1509485-165-79 years2021/07
86MODERNAI 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)1514445-165-79 years2021/07
87MODERNAFollowing 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.1528639-165-79 years2021/08
88MODERNASore; 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; CLL1536851-1Unknown2021/08
89MODERNAI 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.1543295-160-64 years2021/08
90MODERNASevere 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 contactNo current illness for this event.1544580-150-59 years2021/08
91MODERNAchills; 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.1548329-165-79 years2021/08
92MODERNAElevated 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 requestedNo current illness for this event.1551059-165-79 years2021/08
93MODERNAarea 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: AdvilLeukaemia1551189-165-79 years2021/08
94MODERNAMalaise; 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.1551423-165-79 years2021/08
95MODERNAstomach 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.1555419-165-79 years2021/08
96MODERNAbig 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.1556651-165-79 years2021/08
97MODERNAtested 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.1557046-140-49 years2021/08
98MODERNADisgusted 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 leukaemia1559460-165-79 years2021/08
99MODERNAslight 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; Leukemia1560224-165-79 years2021/08
100MODERNAThis 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.1561039-165-79 years2021/08
101MODERNAThis 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.1561359-165-79 years2021/08
102MODERNAFelt 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.)1561897-165-79 years2021/08
103MODERNATooth 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.1563326-165-79 years2021/08
104MODERNAHeart 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 contactChronic lymphocytic leukemia1563428-180+ years2021/08
105MODERNABoth 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 informationLeukemia1564125-165-79 years2021/08
106MODERNAfelling 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)1564295-165-79 years2021/08
107MODERNADeveloped 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.Leukemia1564646-165-79 years2021/08
108MODERNAA 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 low1565768-165-79 years2021/08
109MODERNAvaccination 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.1565923-150-59 years2021/08
110MODERNAlymph 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 leukemia1567525-165-79 years2021/08
111MODERNAThis 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)1567566-165-79 years2021/08
112MODERNAdizziness; 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 informationMigraine (Improvement since pregnancy); Sulfonamide allergy1570856-130-39 years2021/08
113MODERNABrown 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.Leukemia1572381-180+ years2021/08
114MODERNADizzy; 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 informationLeukemia1572774-165-79 years2021/08
115MODERNAHad 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.)1573316-165-79 years2021/08
116MODERNAsoreness 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 contactNo current illness for this event.1580781-150-59 years2021/08
117MODERNASwollen 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.1580874-165-79 years2021/08
118MODERNAImprovement 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.1594661-165-79 years2021/08
119MODERNAterrible 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.1597650-165-79 years2021/08
120MODERNADeveloped 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 FLeukemia (Had leukemia for 30 years)1599355-165-79 years2021/08
121MODERNA"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.1599405-1Unknown2021/08
122MODERNALeg 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 cancer1599681-165-79 years2021/08
123MODERNAExposure 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.1601260-130-39 years2021/08
124MODERNAinjection 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.Leukemia1601613-180+ years2021/08
125MODERNASoreness 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 reportedChronic lymphocytic leukemia (partial remission)1601991-165-79 years2021/08
126MODERNAAches; 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.1601992-165-79 years2021/08
127MODERNApain 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 leukemia1603794-150-59 years2021/08
128MODERNAAntibodies 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.Leukemia1604717-180+ years2021/08
129MODERNAlack 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 NOS1604795-165-79 years2021/08
130MODERNAEnlarge 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 ProvidedChronic lymphocytic leukemia1605887-1Unknown2021/08
131MODERNAHigh 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 leukemia1608316-165-79 years2021/08
132MODERNALeukemia/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 caseArthritis; Tinnitus1608978-1Unknown2021/08
133MODERNAjitters; 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)1609133-165-79 years2021/08
134MODERNAThis 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 breast1610256-165-79 years2021/08
135MODERNAheadache; 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 emailNo current illness for this event.1610720-150-59 years2021/08
136MODERNAThis 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 leukemia1610727-1Unknown2021/08
137MODERNAvaccination 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)1610742-165-79 years2021/08
138MODERNAAbscess; 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 sensitivity1610745-165-79 years2021/08
139MODERNAPatient 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)1612481-165-79 years2021/08
140MODERNAfracture 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)1612844-180+ years2021/08
141MODERNAinjection 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)1612982-165-79 years2021/08
142MODERNAThis 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 leukemia1613624-165-79 years2021/08
143MODERNASwollen 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 contactNo current illness for this event.1613684-160-64 years2021/08
144MODERNAsevere 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 leukaemia1613714-1Unknown2021/08
145MODERNAa 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 leukemia1613952-165-79 years2021/08
146MODERNASore 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 leukemia1614101-140-49 years2021/08
147MODERNAshortness 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 updatedNo current illness for this event.1614136-180+ years2021/08
148MODERNAInjection 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)1614338-165-79 years2021/08
149MODERNARheumatoid 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 leukemia1614640-160-64 years2021/08
150MODERNAVery 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 .Leukemia1616197-180+ years2021/08
151MODERNAdrowsiness; 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 contactNo current illness for this event.1616234-160-64 years2021/08
152MODERNAThis 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.1616858-150-59 years2021/08
153MODERNAPatient 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.1617479-150-59 years2021/08
154MODERNADry 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 syndrome1617868-165-79 years2021/08
155MODERNAWBC 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 leukemia1619314-130-39 years2021/08
156MODERNABruised; 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 leukemia1621108-160-64 years2021/08
157MODERNAA 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 leukemia1621114-160-64 years2021/08
158MODERNAInjection 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.1621135-165-79 years2021/08
159MODERNATold 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.1621440-1Unknown2021/08
160MODERNAExpired 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)1622113-160-64 years2021/08
161MODERNAlittle 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 kidney1622687-150-59 years2021/08
162MODERNAVaccine 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 fungal1626968-160-64 years2021/08
163MODERNASores 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; Welts1627198-165-79 years2021/08
164MODERNAPATIENT 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 ILLNESSES1632483-180+ years2021/08
165MODERNARheumatoid 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 leukemia1635391-160-64 years2021/08
166MODERNAHeadache; 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 disorder1635818-165-79 years2021/08
167MODERNATiredness; 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 leukemia1635823-165-79 years2021/08
168MODERNAPatient 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""Leukemia1639528-140-49 years2021/08
169MODERNAIt 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); Leukemia1639647-150-59 years2021/08
170MODERNAImprovement 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)1639802-160-64 years2021/08
171MODERNABlood 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 addedChronic 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)1640250-180+ years2021/08
172MODERNAAdmit 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 leukemia1641330-165-79 years2021/08
173MODERNAFiscally 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; Rash1643181-165-79 years2021/08
174MODERNAshe 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))1643977-150-59 years2021/08
175MODERNAjoint 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.1644229-165-79 years2021/08
176MODERNAshe 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)1644513-140-49 years2021/08
177MODERNApain 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 excludedNo current illness for this event.1644984-165-79 years2021/08
178MODERNAdiagnosed 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).1645146-165-79 years2021/08
179MODERNAMultiple 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 excludedNo current illness for this event.1645355-165-79 years2021/08
180MODERNAChronic 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.1645368-140-49 years2021/08
181MODERNAchronic phase chronic myeloid leukemiaNo current illness for this event.1651510-140-49 years2021/08
182MODERNADiarrhea; 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.""CLL1658093-165-79 years2021/08
183MODERNA1 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.none1660130-165-79 years2021/08
184MODERNApatient 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).""Leukemia1673013-165-79 years2021/09
185MODERNACongested 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.1673104-150-59 years2021/09
186MODERNAStarted not feeling good on day of injection. This continued until I was diagnosed w Acute myeloid leukemia on  May 28th 2021Atrial fibrillation1674967-165-79 years2021/09
187MODERNAFever; 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).Leukemia1677186-165-79 years2021/09
188MODERNACould 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 leukemia1677222-180+ years2021/09
189MODERNAfirst 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 contactChronic lymphocytic leukemia1678288-1Unknown2021/09
190MODERNA52 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):  PNEUMONIACLL 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-borderline1678911-150-59 years2021/09
191MODERNAI 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.1679235-165-79 years2021/09
192MODERNAEmergency 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; Leukemia1681674-1Unknown2021/09
193MODERNAAcute 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.1681682-180+ years2021/09
194ModernaDeep 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 requestedChronic lymphocytic leukemia; Depression; Drug allergy (allergic reaction to Rituxan.); Glaucoma1189625-165-79 years2021/04
195Modernafluid 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 cofounderAllergic reaction to drug; Allergy to chemicals; Blood pressure high; Chronic lymphocytic leukemia; Fatigue; Fruit allergy (Cantaloupes); Swelling; Swollen lymph nodes1301804-180+ years2021/05
196ModernaCOVID-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.1345838-165-79 years2021/05
197ModernaSaddle 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 lymphoma1401708-160-64 years2021/06
198ModernaPancreatitis; 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 leukemia1435903-160-64 years2021/06
199ModernaHeart 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 contactChronic lymphocytic leukemia1563428-180+ years2021/08
200Modernavaccination 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.1565923-150-59 years2021/08
201Modernaheadache; 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 emailNo current illness for this event.1610720-150-59 years2021/08
202Modernavaccination 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)1610742-165-79 years2021/08
203Modernafracture 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)1612844-180+ years2021/08
204Modernadrowsiness; 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 contactNo current illness for this event.1616234-160-64 years2021/08
205ModernaSores 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; Welts1627198-165-79 years2021/08
206PFIZER\BIONTECHPatient 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.none0934028-130-39 years2021/01
207PFIZER\BIONTECHHeadache; 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.0939432-118-29 years2021/01
208PFIZER\BIONTECHResident 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.0942290-180+ years2021/01
209PFIZER\BIONTECHhe 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.0942622-1Unknown2021/01
210PFIZER\BIONTECH49 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 normalnone0972553-140-49 years2021/01
211PFIZER\BIONTECHResident expired on  1/23/21 . Resident receiving care under  hospice ,diagnosis Acute Myeloid Leukemia.Acute Myeloid Leukemia0972782-180+ years2021/01
212PFIZER\BIONTECHred 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.0973428-180+ years2021/01
213PFIZER\BIONTECHPatient 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.0977432-165-79 years2021/01
214PFIZER\BIONTECHPatient 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.0977472-165-79 years2021/01
215PFIZER\BIONTECHThis 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.0986049-150-59 years2021/01
216PFIZER\BIONTECHSore 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.0990514-1Unknown2021/01
217PFIZER\BIONTECHshe 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.""CLL0997236-1Unknown2021/02
218PFIZER\BIONTECHHeadache; 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.1000523-160-64 years2021/02
219PFIZER\BIONTECHStroke; 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.1000658-165-79 years2021/02
220PFIZER\BIONTECHPatient 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, ESRDsee below1000709-165-79 years2021/02
221PFIZER\BIONTECHChills/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.1004218-165-79 years2021/02
222PFIZER\BIONTECHApproximately 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 CDCnone1017232-130-39 years2021/02
223PFIZER\BIONTECHmuscle 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.1018663-165-79 years2021/02
224PFIZER\BIONTECHI 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.None1028557-150-59 years2021/02
225PFIZER\BIONTECHBody 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.1030046-150-59 years2021/02
226PFIZER\BIONTECHshe 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.1035533-165-79 years2021/02
227PFIZER\BIONTECHFall; 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 AMLNo current illness for this event.1035539-180+ years2021/02
228PFIZER\BIONTECHChest 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.1037939-130-39 years2021/02
229PFIZER\BIONTECHChest 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.1039929-150-59 years2021/02
230PFIZER\BIONTECHhe 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.1048205-1Unknown2021/02
231PFIZER\BIONTECHWhite 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.1048691-1Unknown2021/02
232PFIZER\BIONTECHhard 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 disorder1051002-180+ years2021/02
233PFIZER\BIONTECHgrade 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.1051446-165-79 years2021/02
234PFIZER\BIONTECHMy 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.No1051992-165-79 years2021/02
235PFIZER\BIONTECHPatient 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.1053620-1Unknown2021/02
236PFIZER\BIONTECHinjection 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.1061940-180+ years2021/02
237PFIZER\BIONTECHeyelids 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.1062225-165-79 years2021/02
238PFIZER\BIONTECHPatient 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 2/24/21.1063882-180+ years2021/03
239PFIZER\BIONTECHacute 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.1065922-180+ years2021/02
240PFIZER\BIONTECHbilateral 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.1068264-180+ years2021/03
241PFIZER\BIONTECHacute 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.1070724-1Unknown2021/03
242PFIZER\BIONTECHPatient 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.Unknown1073435-150-59 years2021/03
243PFIZER\BIONTECHBlood 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.1090212-1Unknown2021/03
244PFIZER\BIONTECHitching 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.1100319-165-79 years2021/03
245PFIZER\BIONTECHthey 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 patientNo current illness for this event.1100334-1Unknown2021/03
246PFIZER\BIONTECHhave 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.1100386-1Unknown2021/03
247PFIZER\BIONTECHPain 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.1100444-1Unknown2021/03
248PFIZER\BIONTECHpatient 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.1102132-180+ years2021/03
249PFIZER\BIONTECHPatient was vaccinated with the Pfizer vaccine in early February.  On February 19th, she was diagnosed with Acute Myeloid Leukemiastatin--muscle weakness1103186-165-79 years2021/03
250PFIZER\BIONTECHlymph 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)1106223-140-49 years2021/03
251PFIZER\BIONTECHFever 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 high1106232-165-79 years2021/03
252PFIZER\BIONTECHShingles; 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.1114347-165-79 years2021/03
253PFIZER\BIONTECHblood 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.1115270-180+ years2021/03
254PFIZER\BIONTECH72 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 ITPNo current illness for this event.1115498-165-79 years2021/03
255PFIZER\BIONTECHChills; 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.1119934-160-64 years2021/03
256PFIZER\BIONTECHBilateral 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.1121596-165-79 years2021/03
257PFIZER\BIONTECHMultifocal 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 HemorrhageNo current illness for this event.1140696-165-79 years2021/03
258PFIZER\BIONTECHModerate 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.""Leukemia1150322-165-79 years2021/03
259PFIZER\BIONTECHKnot 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.1153251-165-79 years2021/03
260PFIZER\BIONTECHCAT 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.1153547-165-79 years2021/03
261PFIZER\BIONTECHleukemia; 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.1153552-165-79 years2021/03
262PFIZER\BIONTECHhe 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 leukemia1154027-160-64 years2021/03
263PFIZER\BIONTECHangioedema; 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.1154031-130-39 years2021/03
264PFIZER\BIONTECHtested 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.1158698-1Unknown2021/03
265PFIZER\BIONTECHLeukemia 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.1174027-1Unknown2021/04
266PFIZER\BIONTECHmild 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.1174359-165-79 years2021/04
267PFIZER\BIONTECHFever/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.1183941-165-79 years2021/04
268PFIZER\BIONTECHleukemia; 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 mellitus1191848-160-64 years2021/04
269PFIZER\BIONTECHflu 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.1224061-165-79 years2021/04
270PFIZER\BIONTECHthroat 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 obtainedNo current illness for this event.1224117-160-64 years2021/04
271PFIZER\BIONTECHher 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.1224492-1Unknown2021/04
272PFIZER\BIONTECHa 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.1224498-165-79 years2021/04
273PFIZER\BIONTECHdeveloped 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 200