Q ~ Trust Trump's Plan ~ 01/23/21 Vol.329, Q Day 1184

qalerts.app ^ | 01/23/21 | FReeQs, FReepers, vanity

[ransomnote]

---

Q is the result of the sacrifices and commitment of countless patriots to win back our captured country from the Deep State and achieve the transformation President Trump promised in this campaign video. President Trump has said the awakening of the public is key to this transformation.

Q describes this awakening as follows: 

"The Great Awakening ('Freedom of Thought’), was designed and created not only as a backchannel to the public (away from the longstanding 'mind’ control of the corrupt & heavily biased media) to endure future events through transparency and regeneration of individual thought (breaking the chains of ‘group-think’), but, more importantly, aid in the construction of a vehicle (a ‘ship’) that provides the scattered (‘free thinkers’) with a ‘starter’ new social-networking platform which allows for freedom of thought, expression, and patriotism or national pride (the feeling of love, devotion and sense of attachment to a homeland and alliance with other citizens who share the same sentiment).

When ‘non-dogmatic’ information becomes FREE & TRANSPARENT it becomes a threat to those who attempt to control the narrative and/or the stable. 

When you are awake, you stand on the outside of the stable (‘group-think’ collective), and have ‘free thought’. 

"Free thought" is a philosophical viewpoint which holds that positions regarding truth should be formed on the basis of logic, reason, and empiricism, rather than authority, tradition, revelation, or dogma. 

When you are awake, you are able to clearly see. 

The choice is yours, and yours alone. 

Trust and put faith in yourself. 

You are not alone and you are not in the minority. 

Difficult truths will soon see the light of day. 

WWG1WGA!!!" ~ Q (#3038)

 

The video, Qanon is 100% coming from the Trump Administration, is just one of many excellent responses to the all-important question, "Whom does Q serve?"

Q Boot Camp is a quick, condensed way to learn the background and basics about the Q movement. 

Q has reminded us repeatedly that together, we are strong. As the false "narrative" is destroyed and the divisive machinery put in place by the Deep State fails, the fact that patriotism has no skin color or political party is exposed for all to see. 

In the battle between those who strip us our constitutional rights, we can't afford to let false divisions separate us any longer. We, and our country, will be forever made stronger by diligently seeking the truth, independence and freedom of thought.

Where We Go 1, We Go All

[Openurmind]

Please do. It would be our pleasure and privilege. :)

We will update. :)

[Faith65]

BKMKING

In case any newbies haven’t seen this, CoryDigs offers tool for research:

MY TOOLBOX FOR DIGGING – Help Yourself, and Dig In!

2-Part Article on Hunting The Hunters - digging into webs, nests, and foundations:
https://www.coreysdigs.com/hunting-the-hunters/hunting-the-hunters-inside-the-minds-of-elite-corrupt/

Over 80 resources for digging (I use them all): https://www.coreysdigs.com/resources/

Background Search Database I use:
https://bit.ly/2GfRTM8

2 VPNs I use when doing research:
https://bit.ly/3bk2VMN
https://bit.ly/3bpx5y5

The File Drawer - filled with unclassified docs, transcripts, court docs, flight logs, etc.:
https://www.coreysdigs.com/the-file-drawer/

I’ve written 8 articles on “how to...” research, assess fact from fiction, spot tactics, helpful tools, plus more: https://www.coreysdigs.com/category/learn-how-to/

DIG IN!

https://gab.com/CoreysDigs/posts/105617634275208418

[ransomnote]

TRANSCRIPT BELOW:

Not the usual fair for 60 Minutes: ritual sexual abuse and human sacrifice. I'd seen this interview before but it was scrubbed from that site.

Teresa's escape from brutal 'satanic cult' and bizarre rituals (1989) | 60 Minutes Australia - YouTube

to describe this story as horrifying

would be an understatement and if that

sounds like a warning

then that's exactly what it's meant to

be it deals with the sexual abuse of

children

by satanic cults and not only that human

sacrifices

as well we started investigating these

secret satanic cults

when a british member of parliament

linked them with the ritual murder of

children

in this day and age it sounded too

far-fetched

as did suggestions that the same thing

might be happening

in australia but then we met teresa

she's only 15 and for 12 of those years

she's been the victim of relentless

depravity teresa's story

is both shocking and compelling yet it's

a story she's anxious to tell

but again we should warn you that parts

of this report

may be distressing my friends are family

and

strangers and my family used to rape me

maybe i bought the babies i had

it would be hard to imagine more misery

and suffering

than what theresa says she's had to

endure and us kids

would be made to do

things with the adults and animals

and then a sacrifice would happen

the sacrifice were these animal

sacrifices

animals and um people on what scale do

you think this was happening

enormous far beyond what we've ever

heard of here before

teresa's mother bridget you're talking

about mass murder

yes on a scale that this country's never

heard of before

like the old people's homes

for the first time theresa is learning

what it's like

to live with love instead of fear

in this quiet english village with the

help of a mother

she's slowly repairing her broken life

teresa is now 15 but at the age of two

she was left in the care of this woman

the grandma

she called nan and that she says is when

a torment started

who was the leader who was uh who was

the boss

of the king of the cult

at home it was my name your nan

made you have sex with animals yeah

like goats and donkeys

the story of teresa is a story almost

too horrible to recount a case of child

abuse that goes well beyond the kind of

things

we normally associate with the abuse of

children in 27 years of reporting

it has to be one of the most painful

stories i have ever had to tell

how many men or how many people would

have sex with you

well at one time yes

but everyone who was there which must

have been about 20

you know from 10 to 20 people

if it was a big ceremony it used to be

30.

what would your grandma be doing when

these men were forcing themselves on you

usually laughing or smiling

or having sex with another man

or other men a chronicle of debauchery

and depravity so horrific it's hard to

believe

you have to ask yourself could theresa

be just

making it up no

i know what's true and what's not

now i know what i saw children don't

make up

elaborate lies that this would have to

be if it was a lie

which i i know it is not it isn't

this couldn't be a terrible dream a

nightmare

that you're reliving

no it's no dream

it's a nightmare but it's it's not one

you can wake

up from it's there all the time

this really happened you're quite sure

of that yeah

the police don't think teresa made up a

story

some of the cult members are to stand

trial

five men have been charged with rape as

fernan

the grandmother she's 61 and lives in

this council flat

in south london she's charged on seven

counts of aiding and abetting rape and

two counts

of performing abortions on teresa

if you're finding this hard to believe

so did i at first but then there are the

medical reports

evidence of sustained sexual abuse

and there's this a statement prepared

for 60 minutes

by teresa's psychiatrist it says

in my opinion teresa's account is not

the product

of a psychotic illness nor the figment

of a fertile imagination

i believe her to be telling the truth

i know what's true what's not we also

took teresa's story

to this man therapist ray wire

he reads a transcript of our interview

and listens to her voice

it's no dream few people of any in

britain

have counseled as many victims of

satanic abuse or satanists themselves

as rywire has if there is an expert on

satanic cults

it would have to be him do you believe

teresa's story

i believe theresa's story it's exactly

the same

story as i've heard from men who says

they've done it

you've dealt with other cases like hers

yes 21

cases like hers he says in the past two

years alone

themes like they were put in boxes with

spiders and worms

where they were trapped in fear where

there was a high use of excrement in

urine

where there was talk of human sacrifice

take just one of those rituals putting

children in boxes

with spiders and worms now listen to

what theresa

told her mother and they had a

coffin-like box

that children were put in with spiders

and snakes and the lid shut and left in

there

i would have come out deranged i could

not have coped with that mentally

at all you have evidence to back up

stories like teresa's that this is

really happening we have

that age of child six five and four

giving information that ties up with

teresa

how do those children know

how do those children able to describe

rituals to talk about ceremonies

to talk about sacrificing animals how do

those

children know nightmares imagining it

you can't imagine

those things at three and four years old

and you also

don't have the evidence of anal sex

abuse and oral sex abuse and all that

other abuse

that clearly those children have

experienced and endured

during these ceremonies was satan the

devil ever referred to

he was called lucifer

um

what did they say about the devil about

lucifer

that um killing the people made him

happy

sacrifices to please the devil according

to teresa

the worst rituals took place at a house

somewhere in the country

it was big you know expensive

from the front it looked like a castle

you know i had a long drive

and big double wooden doors

do you think they were rich people then

very rich

now where was this big house somewhere

in the country

teresa says she can't take the police

there because the satanist

made sure she'd never know how to find

it

theresa was always drugged or

on a couple of occasions she said she

was knocked out

um so that she never fully knew the

route

there was a [ __ ] who was brought in

once

you know and he was killed

i used cut from his throat down to his

stomach

and that they hear him

little bits of him they killed a man at

a ceremony

yeah in front of you yeah in front of

all of

all of us did the [ __ ]

did this man fight back no i think he

was

you know drunk or something he

seemed really dopey he was laughing a

lot when he was brought in

and

he started screaming when they began to

cut

but after a while you know he died

i had seen a few killings before then

although i wasn't used to it you know

that was the worst one

i really don't know what i thought

i suppose i thought thank god it's not

me let me get this right now

are you saying that you saw more than

one person

killed in that house yeah

i've seen um loads of babies

killed there just newborn babies

or aborted ones which were only small

you know four-year-olds

any age really did they ever say they

might kill you

uh they threatened to kill my little

girl who's

when i left was still at the house a

friend

huh what little girl my little girl

alex she's about four now

you mean you had a child yeah

how old were you when you had that child

eleven

motherhood at the age of 11.

but from what teresa told her mother it

wasn't the only pregnancy

we think um about seven or eight times

it's hard to say um

it was constantly happening from the

time she was capable

of being pregnant what happened to the

pregnancies to the babies

um they were aborted

by my nan or by one of the doctors at

the house

there were doctors there at that house

yeah there was

um two i think yeah and there

and a nurse what would happen uh

to the fetus as the unborn babies

i used to be taken away most of the time

and one time baby was taken out of me

and then killed

in front of me

because it was still alive and then

what would happen well after they killed

it

i would eat it

well we were also made to eat it

you were made to eat your own fetus yeah

who made you do this

my name

you'd think the one person in the world

you could leave

a little girl with would be grandma

someone to give a love and protector

from harm

yet when theresa was left to live with

her grandmother

they might as well have handed her to

the devil himself

grandmothers i mean the vision it

conjures up for you know sweet old lady

gray hair rosy cheeks holding her arms

out to love her grandchildren

and it was exactly the reverse but why

was theresa

living with nan in the first place and

not with her mother

when my first marriage broke up

um i took the children with me and

couldn't cope

so i gave them to their father

who in turn moved to his mother's

den's place yeah and when he left the

nan's place

um he left the children there how do you

feel now towards her grandma

and the other people who who did all

those things to your daughter

uh they disgust me

they are the worst form of life

this earth has had the misfortune to

create

uh the vile

you ever try to to run away you must

have been

must have been frightened a couple of

times i did

put my uncle he caught me and brought me

back going to the police

did that occur to you no

i thought it was normal you know even

though i didn't like it

you know

i mean you don't like to eat greens but

you you know somewhere you

you know you thought i thought it was

just her being cool to be kind or

something like that

she said to me it was something that

everybody did

she thought you know like you don't like

going to school with a dentist

you don't like going to the black masses

it was never any different i didn't have

nothing to compare it to

all part of life theresa thought even a

miscarriage one day

at school yeah i asked the teacher if i

could

go to the toilet and she allowed me out

i went to the toilet and

um the baby was in the knickers

i thought it was dead but it it wasn't

it was still moving

and yet no one at school knew no saw

anything

no or if they did they didn't say

no she was treated for a high

temperature

a fever nothing more

what did she do with the baby she kept

her

for a while because she was frightened

that they'd use the child as part of the

rituals

so uh she turned

pencil case into a little coffin

apparently

she put roses in to make her smell sweet

put a letter with her pictures of

herself

and her brother a picture of me

and then i put it down the chute

because i didn't want my nan to get it

as we said earlier the police have

already charged some members of the cult

and we know they're also investigating

teresa's accounts

of those ritual killings if there were

as many she told us

then the satanists had a problem how did

they get rid of the bodies

they had um a tub you know

pretty big i don't know

if very big tub and they used to put the

bodies and bones in there and it used to

go like you know fizzy in it

and then there was nothing left

well they didn't seem to be but when

they cleared it out

there used to be a sludge at the bottom

teresa's story her account doesn't

really surprise you

it doesn't surprise me in the light of

satanic abuse now

do you get frustrated with people who

just won't accept that these things do

happen

yes because i i've worked with murderers

in prisons for years

not that long ago a boy was found in a

forest in southern england without a

head

we have no doubts that men can do that

and yet when we start

talking about men within satanism who

actually believe

in evil and it's the right to express

evil we suddenly have a

a doubt as i was leaving teresa's place

she handed me this note it's addressed

to the film crew

she says thanks for bothering to help

kids like me

i hope it helps on the other side

there's a poem

theresa made up while she was staying at

nan's place

she calls it nothing left

nothing left i would scream but there is

no voice left

i would cry but there are no tears left

i'd fight there is no strength left

that was just part of our investigation

of satanism in britain

we're also gathering evidence about the

activities of such cults

here in australia

hello i'm liam bartlett thanks for

watching to keep up with the latest from

60 minutes australia

make sure you subscribe to our channel

you can also download the nine now app

for full episodes and other exclusive 60

minutes content

[Luigi Vasellini]

Satans children link bump

[NetAddicted]

Read later.

[Steve Van Doorn]

Thank you for these figures on total turn out. Much better.
About doubles the average presidential turnout and about 60% greater then our all time record of 2008.

[Steve Van Doorn]

Doubles the average presidential turnout and about 60% 40% greater then our all time record of 2008

[MagnoliaB]

I’m sure Zero was cheated into office that year.

[ransomnote]

Here is the link

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#annex-1-vaccine-analysis-print

Here's the title/link combination

Coronavirus vaccine - weekly summary of Yellow Card reporting - GOV.UK (www.gov.uk)

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

I copied the blob of HTML of the article below in case you want to post it that way. I think uK.gov is copyright free so you could probably post the whole thing. Copy and paste into body of a thread if you decide to post it.

The content about the pregnancies is not at the top of the page, I didn't see it but I didn't look hard so you may want to excerpt or tell people where to look. Or it could be linked to the article (indrectly referenced)

Full article HTML below:

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<div class="gem-c-organisation-logo brand--department-of-health"><a class="gem-c-organisation-logo__container gem-c-organisation-logo__link gem-c-organisation-logo__crest gem-c-organisation-logo__crest--single-identity brand__border-color" href="https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency"><span class="gem-c-organisation-logo__name">Medicines &amp; Healthcare products<br />Regulatory Agency</span></a></div>
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<div class="gem-c-title gem-c-title--inverse govuk-!-margin-top-8 govuk-!-margin-bottom-0"><span class="govuk-caption-xl gem-c-title__context">Research and analysis</span>
<h1 class="gem-c-title__text ">Coronavirus vaccine - weekly summary of Yellow Card reporting</h1>
</div>
<p class="publication-header__last-changed">Updated 25 March 2021</p>
</header>
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<h2 class="gem-c-contents-list__title">Contents</h2>
<ol class="gem-c-contents-list__list">
<li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--numbered"><a class="gem-c-contents-list__link govuk-link " href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#summary" data-track-category="contentsClicked" data-track-action="content_item 1" data-track-label="#summary" data-track-options="{&quot;dimension29&quot;:&quot;Summary&quot;}">Summary</a></li>
<li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--numbered"><a class="gem-c-contents-list__link govuk-link " href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#introduction" data-track-category="contentsClicked" data-track-action="content_item 2" data-track-label="#introduction" data-track-options="{&quot;dimension29&quot;:&quot;\n1. Introduction&quot;}"><span class="gem-c-contents-list__number">1.</span><span class="gem-c-contents-list__numbered-text">Introduction</span></a></li>
<li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--numbered"><a class="gem-c-contents-list__link govuk-link " href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#yellow-card-reports" data-track-category="contentsClicked" data-track-action="content_item 3" data-track-label="#yellow-card-reports" data-track-options="{&quot;dimension29&quot;:&quot;\n2. Yellow Card reports&quot;}"><span class="gem-c-contents-list__number">2.</span><span class="gem-c-contents-list__numbered-text">Yellow Card reports</span></a></li>
<li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--numbered"><a class="gem-c-contents-list__link govuk-link " href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#analysis-of-data" data-track-category="contentsClicked" data-track-action="content_item 4" data-track-label="#analysis-of-data" data-track-options="{&quot;dimension29&quot;:&quot;\n3. Analysis of data&quot;}"><span class="gem-c-contents-list__number">3.</span><span class="gem-c-contents-list__numbered-text">Analysis of data</span></a></li>
<li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--numbered"><a class="gem-c-contents-list__link govuk-link " href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#conclusion-1" data-track-category="contentsClicked" data-track-action="content_item 5" data-track-label="#conclusion-1" data-track-options="{&quot;dimension29&quot;:&quot;\n4. Conclusion&quot;}"><span class="gem-c-contents-list__number">4.</span><span class="gem-c-contents-list__numbered-text">Conclusion</span></a></li>
<li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--numbered"><a class="gem-c-contents-list__link govuk-link " href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#annex-1-vaccine-analysis-print" data-track-category="contentsClicked" data-track-action="content_item 6" data-track-label="#annex-1-vaccine-analysis-print" data-track-options="{&quot;dimension29&quot;:&quot;Annex 1: Vaccine Analysis Print&quot;}">Annex 1: Vaccine Analysis Print</a></li>
<li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--numbered"><a class="gem-c-contents-list__link govuk-link " href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#annex-2-glossary" data-track-category="contentsClicked" data-track-action="content_item 7" data-track-label="#annex-2-glossary" data-track-options="{&quot;dimension29&quot;:&quot;Annex 2 Glossary&quot;}">Annex 2 Glossary</a></li>
</ol>
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<p>This report covers the period 9 December 2020 to 14 March 2021.</p>
<h2 id="summary">Summary</h2>
<p>At the time of this report, over 125,000 people across the UK have died within 28 days of a positive test for coronavirus (COVID-19).&nbsp;<a class="govuk-link" href="https://coronavirus.data.gov.uk/" rel="external">Rates of COVID-19 infection and hospitalisation</a>&nbsp;remain high.</p>
<p>Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. A national immunisation campaign has been underway since early December 2020.</p>
<p>Two COVID-19 vaccines, Pfizer/BioNTech and Oxford University/AstraZeneca vaccines, are currently being used in the UK. Both have been authorised for supply by the Medicines and Healthcare products Regulatory Agency (MHRA) following a thorough review of safety, quality and efficacy information from clinical trials. In&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/collections/mhra-guidance-on-coronavirus-covid-19#vaccines-and-vaccine-safety">clinical trials</a>, both vaccines showed very high levels of protection against symptomatic infections with COVID-19. We expect data to be available soon on the impact of the vaccination campaign in reducing infections and illness in the UK.</p>
<p>All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness.</p>
<p>The Pfizer/BioNTech vaccine was evaluated in clinical trials involving more than 44,000 participants. The most&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/information-for-healthcare-professionals-on-pfizerbiontech-covid-19-vaccine">frequent adverse reactions</a>&nbsp;in trials were pain at the injection site, fatigue, headache, myalgia (muscle pains), chills, arthralgia (joint pains), and fever; these were each reported in more than 1 in 10 people. These reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Adverse reactions were reported less frequently in older adults (over 55 years) than in younger people.</p>
<p>The Oxford University/AstraZeneca vaccine was evaluated in clinical trials involving more than 23,000 participants. The most&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/information-for-healthcare-professionals-on-covid-19-vaccine-astrazeneca">frequently reported adverse reactions</a>&nbsp;in these trials were injection-site tenderness, injection-site pain, headache, fatigue, myalgia, malaise, pyrexia (fever), chills, arthralgia, and nausea; these were each reported in more than 1 in 10 people. The majority of adverse reactions were mild to moderate in severity and usually resolved within a few days of vaccination. Adverse reactions reported after the second dose were milder and reported less frequently than after the first dose. Adverse reactions were generally milder and reported less frequently in older adults (65 years and older) than in younger people.</p>
<p>The MHRA&rsquo;s role is also to continually monitor safety during widespread use of a vaccine. We have in place a&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance">proactive strategy to do this</a>. We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects.</p>
<p>Part of our monitoring role includes reviewing reports of suspected side effects. Any member of the public or health professional can submit suspected side effects through the&nbsp;<a class="govuk-link" href="https://yellowcard.mhra.gov.uk/" rel="external">Yellow Card scheme</a>. The nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated, and especially when most vaccines are being given to the most elderly people and people who have underlying illness.</p>
<p>This safety update report is based on detailed analysis of data up to 14 March 2021. At this date, an estimated 10.9 million first doses of the Pfizer/BioNTech vaccine and 13.7 million doses of the Oxford University/AstraZeneca vaccine had been administered, and around 1.3 million second doses, mostly the Pfizer/BioNTech vaccine, had been administered. This represents an increase of 2.3 million on the previous week, predominately Oxford University/AstraZeneca vaccine.</p>
<p>As of 14 March 2021, for the UK, 38,084 Yellow Cards have been reported for the Pfizer/BioNTech, 78,223 have been reported for the Oxford University/AstraZeneca vaccine, and 325 have been reported where the brand of the vaccine was not specified.</p>
<p>For both vaccines the overall reporting rate is around 3 to 6 Yellow Cards per 1,000 doses administered.</p>
<p>In the week since the previous summary for 07 March 2021 we have received a further 2,759 Yellow Cards for the Pfizer/BioNTech vaccine, 16,919 for the Oxford University/AstraZeneca vaccine and 44 where the brand was not specified. A higher number of doses of the Oxford University/AstraZeneca vaccine were administered in the last week than the Pfizer/BioNTech vaccine.</p>
<p>It is important to note that Yellow Card data cannot be used to derive side effect rates or compare the safety profile of COVID-19 vaccinations as many factors can influence ADR reporting.</p>
<p>For both vaccines, the overwhelming majority of reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as &lsquo;flu-like&rsquo; illness, headache, chills, fatigue (tiredness), nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness.</p>
<p>These types of reactions reflect the normal immune response triggered by the body to the vaccines. They are typically seen with most types of vaccine and tend to resolve within a day or two. The nature of reported suspected side effects is broadly similar across age groups, although, as was seen in clinical trials and as is usually seen with other vaccines, they may be reported more frequently in younger adults.</p>
<h3 id="severe-allergy">Severe allergy</h3>
<p>On 9 December 2020, the MHRA issued preliminary guidance on severe allergic reactions after the Pfizer/BioNTech vaccine due to early reports of anaphylaxis. Following further detailed review, this advice was amended on 30 December to the&nbsp;<a class="govuk-link" href="https://www.gov.uk/drug-safety-update/covid-19-vaccines-pfizer-slash-biontech-and-covid-19-vaccine-astrazeneca-current-advice">current advice</a>. This advice is that people with a previous history of severe allergic reactions to any ingredients of the vaccine should not receive it. People who receive the vaccine should be monitored for at least 15 minutes afterwards.</p>
<p>Widespread use of the vaccine now suggests that severe allergic reactions to the Pfizer/BioNTech vaccine are very rare. Anaphylaxis can also be a very rare side effect associated with most other vaccines.</p>
<p>Following very substantial exposure across the UK population, no other new safety concerns have been identified from reports received so far.</p>
<h3 id="blood-clots">Blood clots</h3>
<p>Following a rigorous scientific review of all the available data, the available evidence does not suggest that blood clots in veins (venous thromboembolism) are caused by COVID-19 Vaccine AstraZeneca.</p>
<p><a class="govuk-link" href="https://www.gov.uk/government/news/uk-regulator-confirms-that-people-should-continue-to-receive-the-covid-19-vaccine-astrazeneca">The MHRA&rsquo;s advice remains that the benefits of the vaccines against COVID-19 continue to outweigh any risks</a>&nbsp;and that the public should continue to get their vaccine when invited to do so.</p>
<h3 id="conclusion">Conclusion</h3>
<ul>
<li>The increases in number of ADR reports reflects the increase in vaccine deployment as new vaccination centres have opened across the UK</li>
<li>The number and nature of suspected adverse reactions reported so far are not unusual in comparison to other types of routinely used vaccines</li>
<li>The overall safety experience with both vaccines is so far as expected from the clinical trials</li>
<li>Based on current experience, the expected benefits of both COVID-19 vaccines in preventing COVID-19 and its serious complications far outweigh any known side effects</li>
<li>As with all vaccines and medicines, the safety of COVID-19 vaccines is being continuously monitored</li>
</ul>
<p>Further information on the type of suspected adverse reactions (ADRs) reported for the COVID-19 mRNA Pfizer/BioNTech vaccine and the COVID-19 Vaccine AstraZeneca is provided in Annex 1. It is important to read the guidance notes to ensure appropriate interpretation of the data.</p>
<h2 id="introduction"><span class="number">1.&nbsp;</span>Introduction</h2>
<p>The MHRA is the executive Agency of the Department of Health and Social Care that acts to protect and promote public health and patient safety, by ensuring that medicines and medical devices meet appropriate standards of safety, quality and efficacy.</p>
<p>The MHRA operates the&nbsp;<a class="govuk-link" href="https://yellowcard.mhra.gov.uk/" rel="external">Yellow Card scheme</a>&nbsp;on behalf of the Commission on Human Medicines (CHM). The scheme collects and monitors information on suspected safety concerns or incidents involving vaccines, medicines, medical devices, and e-cigarettes. The scheme relies on voluntary reporting of suspected adverse incidents by healthcare professionals and members of the public (patients, users, or carers). The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation. Further information about the Yellow Card scheme, including its contribution to identifying safety issues can be found on the&nbsp;<a class="govuk-link" href="https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/" rel="external">Yellow Card website</a>.</p>
<p>The MHRA has played an active role in responding to the coronavirus pandemic. In relation to COVID-19 vaccines, the MHRA has authorised their supply following a rigorous review of their safety, quality and efficacy. The clinical trials of COVID-19 vaccines have shown them to be effective and acceptably safe; however, as part of its statutory functions, the MHRA is responsible for monitoring these vaccines on an ongoing basis to ensure their benefits continue to outweigh any risks. This is a requirement for all authorised medicines and vaccines in the UK. This monitoring strategy is continuous, proactive and based on a wide range of information sources, with a dedicated team of scientists reviewing information daily to look for safety issues or unexpected rare events.</p>
<p>This report summarises information received via the Yellow Card scheme and will be published regularly to include other safety investigations carried out by the MHRA under the&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance">COVID-19 Vaccine Surveillance Strategy</a>.</p>
<h3 id="what-is-a-yellow-card">What is a Yellow Card?</h3>
<p>The Yellow Card scheme is a mechanism by which anybody can voluntarily report any suspected adverse reactions or side effects to the vaccine. It is very important to note that a Yellow Card report does not necessarily mean the vaccine caused that reaction or event. We ask for any suspicions to be reported, even if the reporter isn&rsquo;t sure if it was caused by the vaccine. Reports to the scheme are known as suspected adverse reactions (ADRs).</p>
<p>Many suspected ADRs reported on a Yellow Card do not have any relation to the vaccine or medicine and it is often coincidental that they both occurred around the same time. The reports are continually reviewed to detect possible new side effects that may require regulatory action, and to differentiate these from things that would have happened regardless of the vaccine or medicine being administered, for instance due to underlying or undiagnosed illness.</p>
<p>It is therefore important that the suspected ADRs described in this report are not interpreted as being proven side effects of COVID-19 vaccines. A list of the possible side effects of&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19">COVID-19 mRNA Pfizer/BioNTech</a>&nbsp;and the&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca">COVID-19 Vaccine AstraZeneca</a>&nbsp;is provided in the product information document for healthcare professionals and the UK recipient information. These can also be found on the&nbsp;<a class="govuk-link" href="https://coronavirus-yellowcard.mhra.gov.uk/" rel="external">Coronavirus Yellow Card reporting site</a>.</p>
<p>This public summary provides an overview of all UK suspected ADRs associated with the new coronavirus (COVID-19) vaccines (COVID-19 mRNA Pfizer/BioNTech and COVID-19 Oxford University/AstraZeneca vaccine), and MHRA&rsquo;s analysis of the data, between 9 December 2020 and 14 March 2021 (inclusive). A glossary of key terms is provided in Annex 2.</p>
<p>If identified, information on new and emerging safety concerns will be provided in future editions of this report together with details of any resulting regulatory action or changes to advice on use of the vaccines.</p>
<h2 id="yellow-card-reports"><span class="number">2.&nbsp;</span>Yellow Card reports</h2>
<h3 id="vaccine-doses-administered">Vaccine doses administered</h3>
<p>Data from the UK&nbsp;<a class="govuk-link" href="https://coronavirus.data.gov.uk/details/vaccinations" rel="external">Public Health agencies</a>&nbsp;show that at least 24,453,221 people have received their first vaccination in the UK by week ending 14 March 2021, with 1,610,280 second doses administered. The current priority groups of the immunisation campaign include people over the age of 50 years, the clinically vulnerable, care home residents and workers, and frontline health and social care workers.</p>
<h3 id="table-1-number-of-people-who-have-received-the-first-dose-of-a-vaccination-for-covid-19-in-the-uk-between-8-december-2020-and-end-of-14-march-2021">Table 1: Number of people who have received the first dose of a vaccination for COVID-19 in the UK between 8 December 2020 and end of 14 March 2021.</h3>
<table>
<thead>
<tr>
<th scope="col">Country</th>
<th scope="col">Number of doses</th>
</tr>
</thead>
<tbody>
<tr>
<td>England</td>
<td>20,791,838</td>
</tr>
<tr>
<td>Wales</td>
<td>1,122,931</td>
</tr>
<tr>
<td>Northern Ireland</td>
<td>629,461</td>
</tr>
<tr>
<td>Scotland</td>
<td>1,908,991</td>
</tr>
</tbody>
</table>
<h3 id="table-2-number-of-people-who-have-received-the-second-dose-of-a-vaccination-for-covid-19-in-the-uk-between-8-december-2020-and-end-of-14-march-2021">Table 2: Number of people who have received the second dose of a vaccination for COVID-19 in the UK between 8 December 2020 and end of 14 March 2021.</h3>
<table>
<thead>
<tr>
<th scope="col">Country</th>
<th scope="col">Number of doses</th>
</tr>
</thead>
<tbody>
<tr>
<td>England</td>
<td>1,129,444</td>
</tr>
<tr>
<td>Wales</td>
<td>264,255</td>
</tr>
<tr>
<td>Northern Ireland</td>
<td>54,636</td>
</tr>
<tr>
<td>Scotland</td>
<td>161,945</td>
</tr>
</tbody>
</table>
<p>As of 14 March, an estimated 10.9 million first doses of the Pfizer/BioNTech vaccine and 13.7 million doses of the Oxford University/AstraZeneca vaccine, had been administered, and around 1.3 million second doses, mostly the Pfizer/BioNTech vaccine, had been administered.</p>
<p>The estimated number of doses administered differs from the estimated number of people vaccinated due to the different data sources used.</p>
<h3 id="yellow-card-reporting-trends">Yellow Card reporting trends</h3>
<p>A report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the two vaccines. All reports are kept under continual review in order to identify possible new risks.</p>
<p>Up to and including 14 March 2021, the MHRA received and analysed 38,084 UK Yellow Cards from people who have received the COVID-19 mRNA Pfizer/BioNTech vaccine. These reports include a total of 108,649 suspected reactions (i.e. a single report may contain more than one symptom). The first report was received on 9 December 2020.</p>
<p>Up to and including 14 March 2021, the MHRA received and analysed a total of 78,223 UK reports of suspected ADRs to the COVID-19 Oxford University/AstraZeneca vaccine. These reports include a total of 294,820 suspected reactions (a single report may contain more than one symptom). The first report was received on 4 January 2021.</p>
<p>Additionally, up to and including 14 March 2021, the MHRA received 325 Yellow Card reports where the brand of vaccine was not specified by the reporter.</p>
<p>In the week since the previous summary for 07 March 2021 we have received a further 2,759 Yellow Cards for the Pfizer/BioNTech vaccine, 16,919 for the Oxford University/AstraZeneca vaccine and 44 where the brand was not specified. A higher number of doses of the Oxford University/AstraZeneca vaccine were administered in the last week than the Pfizer/BioNTech vaccine.</p>
<p>It is important to note that Yellow Card data cannot be used to derive side effect rates or compare the safety profile of COVID-19 vaccinations as many factors can influence ADR reporting.</p>
<h3 id="table-3-number-of-suspected-adr-reports-received-in-the-uk-up-to-and-including-14-march-2021">Table 3: Number of suspected ADR reports received in the UK up to and including 14 March 2021.</h3>
<table>
<thead>
<tr>
<td>&nbsp;</td>
<th scope="col">Number of reports</th>
<th scope="col">Number of reports</th>
<th scope="col">Number of reports</th>
</tr>
<tr>
<th scope="col">Country</th>
<th scope="col">Pfizer/ BioNtech</th>
<th scope="col">Oxford University/ AstraZeneca</th>
<th scope="col">Brand unspecified</th>
</tr>
</thead>
<tbody>
<tr>
<td>England</td>
<td>30,343</td>
<td>69,427</td>
<td>172</td>
</tr>
<tr>
<td>Wales</td>
<td>2,308</td>
<td>2,840</td>
<td>18</td>
</tr>
<tr>
<td>Northern Ireland</td>
<td>736</td>
<td>665</td>
<td>3</td>
</tr>
<tr>
<td>Scotland</td>
<td>2,971</td>
<td>4,246</td>
<td>33</td>
</tr>
</tbody>
</table>
<p>The figures in table 3 are based upon the postcode provided by the reporter. The sums of the reports in the table will not equal the total reports received for each vaccine as postcode may not have always been provided or may have been entered incorrectly. It is important to note that the number of reports received for each country does not directly equate to the number of people who may have experienced adverse reactions and therefore cannot be used to determine the incidence of reactions. ADR reporting rates are influenced by many aspects, including the extent of use.</p>
<p>We are working with public health bodies and encouraging all healthcare professionals and patients alike to report any suspected ADRs to the Yellow Card scheme. As expected, reports gradually increase in line with an increase in doses administered.</p>
<p>The overall reporting rate is in the order of 3 to 6 Yellow Cards per 1,000 doses administered for both vaccines. It is known from the clinical trials that the more common side effects for both vaccines can occur at a rate of more than one in 10 doses (for example, local reactions or symptoms resembling transient flu-like symptoms).</p>
<h2 id="analysis-of-data"><span class="number">3.&nbsp;</span>Analysis of data</h2>
<p>One of MHRA&rsquo;s main roles is to continually monitor safety of medicines and vaccines during widespread use, and we have in place a&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance">proactive strategy to do this</a>&nbsp;for COVID-19 vaccines. We also work closely with our public health partners in reviewing the effectiveness and impact that the vaccines are having to ensure benefits continue to outweigh any possible side effects. In addition, we work with our international counterparts to gather information on the safety of vaccines in other countries.</p>
<p>Given the huge scale of the COVID-19 immunisation programme, with many millions of doses of vaccine administered over a relatively short time period, vigilance needs to be continuous, proactive and as near real-time as is possible. The importance of this is two-fold. First we need to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. We then can take any necessary action to minimise risks to individuals.</p>
<p>Secondly, we need to very quickly establish if any serious medical events which are temporally-related to vaccination are merely a coincidental association. These associations are likely while we are still in the midst of a national epidemic, and because most of the millions of people offered the vaccine in this early phase of a vaccination campaign are elderly and/or have underlying medical conditions, which increases the likelihood of unrelated illnesses occurring soon after vaccination. As mentioned above, the nature of Yellow Card reporting means that reported events are not always proven adverse reactions, and some may have happened regardless of vaccination.</p>
<p>Yellow Card reports of suspected ADRs are evaluated, together with additional sources of evidence, by a team of safety experts to identify any new safety issues or side effects. We apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of vaccination. This aims to account for factors such as coincidental illness. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern.</p>
<p>We supplement this form of safety monitoring with other epidemiology studies including analysis of data on national vaccine usage, anonymised GP-based electronic healthcare records and other healthcare data to proactively monitor safety. These combined safety data enable the MHRA to detect side effects or safety issues associated with COVID-19 vaccines. As well as confirming new risks, an equally important objective of monitoring will be to quickly rule out risks &ndash; in other words to confirm that the vaccine is not responsible for a suspected side effect and to provide reassurance on its safety and this is discussed below.</p>
<p>We also take into account the international experience based on data from other countries using the same vaccines.</p>
<h3 id="overall-safety">Overall safety</h3>
<p>As with any vaccine, the COVID-19 vaccines will cause side effects in some people. The total number and the nature of Yellow Cards reported so far is not unusual for a new vaccine for which members of the public and healthcare professionals are encouraged to report any suspected adverse reaction.</p>
<p>As highlighted above, it is known from the clinical trials that the most common side effects for both vaccines can occur at a rate of more than one per 10 doses (such as local reactions, symptoms resembling transient flu-like symptoms). Overall, Yellow Card reporting is therefore lower than the reporting rate of possible side effects from the clinical trials, although we generally do not expect all suspected side effects to be reported on Yellow Cards. The primary purpose of Yellow Card reporting is to detect new safety concerns.</p>
<p>For both vaccines, detailed review of all reports has found that the overwhelming majority relate to injection site reactions (sore arm for example) and generalised symptoms such as a &lsquo;flu-like&rsquo; illness, headache, chills, fatigue (tiredness), nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness. These types of reaction reflect the acute immune response triggered by the body to the vaccines, are typically seen with most types of vaccine and tend to resolve within a day or two. The nature of reported suspected ADRs across all ages is broadly similar, although, as seen in the clinical trials and as is usually seen with other vaccines, they may be reported more frequently in younger adults.</p>
<p>As we receive more reports of these types of reactions with more exposure to the COVID-19 vaccines, we are building a picture of how individuals are experiencing them and the different ways that side effects may present in people. Some people have reported a sudden feeling of cold with shivering/shaking accompanied by a rise in temperature, often with sweating, headache (including migraine-like headaches), nausea, muscle aches and feeling unwell, starting within a day of having the vaccine. Similar to the flu like illness reported in clinical trials, these effects may last a day or two.</p>
<p>It is important to note that it is possible to have caught COVID-19 and not realise until after vaccination. If other COVID symptoms are experienced or fever is high and lasts longer than two or three days, vaccine recipients should stay at home and arrange to have a test.</p>
<h3 id="glossary">Comments on specific reports</h3>
<p>The following reports reflect data up to 14 March 2021. The glossary provides an explanation of the clinical terms used.</p>
<h3 id="anaphylaxis-severe-allergic-reactions">Anaphylaxis (Severe allergic reactions)</h3>
<p>The MHRA continues to monitor reports of serious allergic reactions with the Pfizer/BioNTech COVID-19 vaccine and has received 237 UK spontaneous adverse reactions associated with anaphylaxis or anaphylactoid reactions. The nature and frequency of these reports is in line with that reported in previous updates, and severe allergic reactions to the Pfizer/BioNTech vaccine remain very rare. The MHRA&rsquo;s guidance remains that those with a previous history of allergic reactions to the ingredients of the vaccine should not receive it.</p>
<p>The MHRA also closely monitors reports of anaphylaxis or anaphylactoid reactions with the AstraZeneca vaccine, and has received 326 UK spontaneous adverse reactions associated with anaphylaxis or anaphylactoid reactions reported, and is very rare. An update to the product information has been made to reflect the fact that cases of anaphylaxis have been reported for the AstraZeneca vaccine.</p>
<h3 id="bells-palsy">Bell&rsquo;s Palsy</h3>
<p>The MHRA continues to review cases reporting Bell&rsquo;s Palsy and to analyse case reports against the number expected to occur by chance in the absence of vaccination (the &lsquo;natural rate&rsquo;). The number of reports of facial paralysis received so far is similar to the expected natural rate and does not currently suggest an increased risk following the vaccines. We will continue to monitor these events, including through evaluation of electronic healthcare record data.</p>
<h3 id="thrombo-embolic-events">Thrombo-embolic events</h3>
<p>Following a rigorous scientific review of all the available data, the available evidence does not suggest that blood clots in veins (venous thromboembolism) are caused by COVID-19 Vaccine AstraZeneca. This follows a detailed review of reported cases as well as data from hospital admissions and GP records. This has been confirmed by the Government&rsquo;s independent advisory group, the Commission on Human Medicines, whose expert scientists, and clinicians have also reviewed the available data.</p>
<p>A further, detailed review into UK reports of a very rare and specific type of blood clot in the cerebral veins (sinus vein thrombosis) occurring together with lowered platelets (thrombocytopenia) is ongoing. This has been reported in less than 1 in a million people vaccinated so far in the UK and can also occur naturally &ndash; a causal association with the vaccine has not been established.</p>
<p>The MHRA&rsquo;s advice remains that the benefits of the vaccines against COVID-19 continue to outweigh any risks and that the public should continue to get their vaccine when invited to do so. For more information, see&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/news/uk-regulator-confirms-that-people-should-continue-to-receive-the-covid-19-vaccine-astrazeneca">our statement</a>.</p>
<h3 id="events-with-a-fatal-outcome">Events with a fatal outcome</h3>
<p>Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination. A high proportion of people vaccinated in the vaccination campaign so far are very elderly, many of whom will also have pre-existing medical conditions. Older age and chronic underlying illnesses make it more likely that coincidental adverse events will occur, especially given the millions of people vaccinated. It is therefore important that we carefully review these reports to distinguish possible side effects from illness that would have occurred irrespective of vaccination.</p>
<p>Part of our continuous analysis includes an evaluation of natural death rates over time, to determine if any specific trends or patterns are occurring that might indicate a vaccine safety concern. Based on age-stratified all-cause mortality in England and Wales taken from the Office for National Statistics death registrations, several thousand deaths are expected to have occurred, naturally, within 7 days of the many millions of doses of vaccines administered so far, mostly in the elderly.</p>
<p>The MHRA has received 259 UK reports of suspected ADRs to the Pfizer/BioNTech vaccine in which the patient died shortly after vaccination, 326 reports for the Oxford University/AstraZeneca vaccine and 9 where the brand of vaccine was unspecified. The majority of these reports were in elderly people or people with underlying illness. Usage of the AstraZeneca has increased rapidly and as such, so has reporting of fatal events with a temporal association with vaccination however, this does not indicate a link between vaccination and the fatalities reported. Review of individual reports and patterns of reporting does not suggest the vaccine played a role in the death.</p>
<h2 id="conclusion-1"><span class="number">4.&nbsp;</span>Conclusion</h2>
<p>At the time of this report, over 125,000 people across the UK have died within 28 days of a positive test for coronavirus. Rates of COVID-19 infection and hospitalisation remain&nbsp;<a class="govuk-link" href="https://coronavirus.data.gov.uk/" rel="external">high</a>.</p>
<p>Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. A national immunisation campaign has been underway since early December 2020.</p>
<p>In&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/collections/mhra-guidance-on-coronavirus-covid-19#vaccines-and-vaccine-safety">clinical trials</a>, the Pfizer/BioNTech and Oxford University/AstraZeneca COVID-19 vaccines have demonstrated very high levels of protection against symptomatic infection. We expect data to be available soon on the impact of the vaccination campaign in reducing infections and illness with COVID-19 in the UK.</p>
<p>All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness.</p>
<p>Following widespread use of these vaccines across the UK, the vast majority of suspected adverse reaction reports so far confirm the safety profile seen in clinical trials. Most reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as a &lsquo;flu-like&rsquo; illness, headache, chills, fatigue, nausea, fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these reactions are not associated with more serious illness and likely reflect an expected, normal immune response to the vaccines.</p>
<p>Following very substantial exposure across the UK population, no other new safety concerns have been identified from reports received to date, and for the cases of other medical conditions reported in temporal association with vaccination, the available evidence does not currently suggest that the vaccine caused the event.</p>
<p>The overall safety experience with both vaccines is so far as expected from the clinical trials. The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is a continuously monitored and benefits and possible risks remain under review.</p>
<p>We take every report of a suspected ADR seriously and encourage everyone to report through the Yellow Card scheme.</p>
<h2 id="annex-1-vaccine-analysis-print">Annex 1: Vaccine Analysis Print</h2>
<p>The attached Vaccine Analysis Profile contains a complete listing of all suspected adverse reactions or that have been reported to the MHRA via the Yellow Card scheme for the COVID-19 mRNA Pfizer/BioNTech vaccine. This includes all reports received from healthcare professionals, members of the public, and pharmaceutical companies.</p>
<p>This information does not represent an overview of the potential side effects associated with the vaccines. A list of the recognised adverse effects of COVID-19 vaccines is provided in the information for healthcare professionals and the recipient information here. These can also be found on the&nbsp;<a class="govuk-link" href="https://coronavirus-yellowcard.mhra.gov.uk/" rel="external">Coronavirus Yellow Card reporting site</a>. Conclusions on the safety and risks of the vaccines cannot be made on the data shown in the Print alone.</p>
<p>When viewing the vaccine analysis print you should remember that:</p>
<ul>
<li>Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the medicine may have caused the adverse reaction. The existence of an adverse reaction report in the print does not necessarily mean that the vaccine has caused the suspected reaction.</li>
<li>It may be difficult to tell the difference between something that has occurred naturally and a suspected adverse reaction. Sometimes these events can be part of the condition being treated rather than being caused by the vaccine.</li>
<li>Many factors have to be considered when assessing whether the vaccine has caused a reported adverse reaction. When monitoring the safety of vaccines and medicines, MHRA staff carry out careful analysis of these factors.</li>
</ul>
<p>For a medicine or vaccine to be considered safe, the expected benefits will be greater than the risk of having harmful reactions. It is important to note that most people take medicines and vaccines without having any serious side effects.</p>
<p><a class="govuk-link" href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/964207/COVID-19_mRNA_Pfizer-_BioNTech_Vaccine_Analysis_Print__1_.pdf" rel="external">Vaccine Analysis Profile - Pfizer/BioNTech</a></p>
<p><a class="govuk-link" href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/964208/COVID-19_AstraZeneca_Vaccine_Analysis_Print__2_.pdf" rel="external">Vaccine Analysis Profile - Oxford University/AstraZeneca</a></p>
<p><a class="govuk-link" href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/964209/COVID-19_vaccine_brand_unspecified_analysis_print__1_.pdf" rel="external">Vaccine Analytics Profile - brand unspecified</a></p>
<h2 id="annex-2-glossary">Annex 2 Glossary</h2>
<h3 id="anaphylaxis-or-anaphylactoid-reactions">Anaphylaxis or anaphylactoid reactions</h3>
<p>Anaphylaxis is a severe and potentially life-threatening allergic reaction. These reactions can occur after an exposure to a trigger, such as a certain ingredient in foods or medicines or an insect sting. Anaphylaxis and anaphylactoid reactions can be treated with adrenaline.</p>
<h3 id="bells-palsy-1">Bell&rsquo;s palsy</h3>
<p>Bell&rsquo;s palsy is a condition that causes temporary weakness or paralysis (lack of movement) of the muscles in one side of the face. It is the most common cause of facial paralysis. For most people, the facial paralysis is temporary. Viral infections such as those with herpes viruses have been linked to Bell&rsquo;s palsy.</p>
<h3 id="clinical-practice-research-datalink-cprd">Clinical Practice Research Datalink (CPRD)</h3>
<p><a class="govuk-link" href="https://www.cprd.com/" rel="external">Clinical Practice Research Datalink</a>&nbsp;(CPRD) is a real-world research service to support public health and clinical studies. CPRD is jointly sponsored by the Medicines and Healthcare products Regulatory Agency and the National Institute for Health Research (NIHR), as part of the Department of Health and Social Care. CPRD collects anonymised patient data from a network of GP practices across the UK.</p>
<h3 id="commission-on-human-medicines-chm">Commission on Human Medicines (CHM)</h3>
<p>The&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/organisations/commission-on-human-medicines">Commission on Human Medicines</a>&nbsp;(CHM) advises ministers on the safety, efficacy and quality of medicinal products. For COVID-19 vaccines, the CHM has a COVID-19 Vaccines Safety Surveillance Methodologies Expert Working Group and a COVID-19 Vaccines Benefit Risk Expert Working Group.</p>
<h3 id="epidemiology-studies">Epidemiology studies</h3>
<p>Epidemiological studies include large numbers of people and are designed to compare the risk of a particular event in an exposed population, in this case those who have received a vaccine, to those who have not. They attempt to account for differences in the different groups to help us understand if any difference in risk is caused by the exposure. Epidemiological studies measure the risk of illness or death in an exposed population compared to that risk in an identical, unexposed population.</p>
<h3 id="regulation-174-authorisation">Regulation 174 authorisation</h3>
<p>Temporary authorisation for supply of a medicine or vaccine by the UK Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency. This temporary authorisation grants permission for a medicine (vaccine) to be used for active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus. Authorisation is subject to a number of conditions. These are available for each vaccine on the MHRA website.</p>
<h3 id="suspected-adverse-reactions">Suspected adverse reactions</h3>
<p>Also known as side effects. All medicines or vaccines can cause adverse reactions in some people. Adverse drug reactions reported to the MHRA are looked at and used to assess the balance of risks and benefits of medicines and vaccines.</p>
<h3 id="temporal-association">Temporal Association</h3>
<p>Events occurring following vaccination but may or may not be caused by the vaccine.</p>
<h3 id="yellow-card-scheme">Yellow Card scheme</h3>
<p>The MHRA&rsquo;s scheme for healthcare professionals and members of the public to report suspected adverse reactions for a medicine or vaccine, as well as medical devices and other products. The&nbsp;<a class="govuk-link" href="https://coronavirus-yellowcard.mhra.gov.uk/" rel="external">dedicated Coronavirus Yellow Card reporting site</a> was launched in May 2020 specifically for medicines and medical devices used in COVID-19, as well as COVID-19 vaccines when authorised.</p>
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[M Kehoe]

Bttt.

5.56mm

[Fractal Trader]

HTML problems — not correctly closed?

[ransomnote]

It displays properly for me.

Hmmm.... I can paste it on this thread and you can link to it in your post. Your post would be primarily your reason for posting (what it includes) and a link to the content of the thread 'out here'.

~~~~~

Or offer: "click the link to view the report on UK.gov" link goes here "Click the link to view the report on FR"

[Fractal Trader]

This is what I see on 2189:

1. Home
2. Vigilance, safety alerts and guidance
3. Coronavirus (COVID-19) vaccine adverse reactions

[ransomnote]

It displays correctly for me.

You could post without active links (no html) and link to it wherever you have me post the HTML version on FR and also provide the link to read it on UK.gov.

Or just no HTML and invite them to read the article at the link. We’d still have the html out here (please record the lcoation) if the article is deleted. :)

[Fractal Trader]

Let's try this:

1. Home
2. Vigilance, safety alerts and guidance
3. Coronavirus (COVID-19) vaccine adverse reactions

• Medicines & Healthcare products
  Regulatory Agency

Research and analysis

Coronavirus vaccine - weekly summary of Yellow Card reporting

Updated 25 March 2021

Contents

1. Summary
2. 1.Introduction
3. 2.Yellow Card reports
4. 3.Analysis of data
5. 4.Conclusion
6. Annex 1: Vaccine Analysis Print
7. Annex 2 Glossary

Print this page

 

This report covers the period 9 December 2020 to 14 March 2021.

Summary

At the time of this report, over 125,000 people across the UK have died within 28 days of a positive test for coronavirus (COVID-19). Rates of COVID-19 infection and hospitalisation remain high.

Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. A national immunisation campaign has been underway since early December 2020.

Two COVID-19 vaccines, Pfizer/BioNTech and Oxford University/AstraZeneca vaccines, are currently being used in the UK. Both have been authorised for supply by the Medicines and Healthcare products Regulatory Agency (MHRA) following a thorough review of safety, quality and efficacy information from clinical trials. In clinical trials, both vaccines showed very high levels of protection against symptomatic infections with COVID-19. We expect data to be available soon on the impact of the vaccination campaign in reducing infections and illness in the UK.

All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness.

The Pfizer/BioNTech vaccine was evaluated in clinical trials involving more than 44,000 participants. The most frequent adverse reactions in trials were pain at the injection site, fatigue, headache, myalgia (muscle pains), chills, arthralgia (joint pains), and fever; these were each reported in more than 1 in 10 people. These reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Adverse reactions were reported less frequently in older adults (over 55 years) than in younger people.

The Oxford University/AstraZeneca vaccine was evaluated in clinical trials involving more than 23,000 participants. The most frequently reported adverse reactions in these trials were injection-site tenderness, injection-site pain, headache, fatigue, myalgia, malaise, pyrexia (fever), chills, arthralgia, and nausea; these were each reported in more than 1 in 10 people. The majority of adverse reactions were mild to moderate in severity and usually resolved within a few days of vaccination. Adverse reactions reported after the second dose were milder and reported less frequently than after the first dose. Adverse reactions were generally milder and reported less frequently in older adults (65 years and older) than in younger people.

The MHRA’s role is also to continually monitor safety during widespread use of a vaccine. We have in place a proactive strategy to do this. We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects.

Part of our monitoring role includes reviewing reports of suspected side effects. Any member of the public or health professional can submit suspected side effects through the Yellow Card scheme. The nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated, and especially when most vaccines are being given to the most elderly people and people who have underlying illness.

This safety update report is based on detailed analysis of data up to 14 March 2021. At this date, an estimated 10.9 million first doses of the Pfizer/BioNTech vaccine and 13.7 million doses of the Oxford University/AstraZeneca vaccine had been administered, and around 1.3 million second doses, mostly the Pfizer/BioNTech vaccine, had been administered. This represents an increase of 2.3 million on the previous week, predominately Oxford University/AstraZeneca vaccine.

As of 14 March 2021, for the UK, 38,084 Yellow Cards have been reported for the Pfizer/BioNTech, 78,223 have been reported for the Oxford University/AstraZeneca vaccine, and 325 have been reported where the brand of the vaccine was not specified.

For both vaccines the overall reporting rate is around 3 to 6 Yellow Cards per 1,000 doses administered.

In the week since the previous summary for 07 March 2021 we have received a further 2,759 Yellow Cards for the Pfizer/BioNTech vaccine, 16,919 for the Oxford University/AstraZeneca vaccine and 44 where the brand was not specified. A higher number of doses of the Oxford University/AstraZeneca vaccine were administered in the last week than the Pfizer/BioNTech vaccine.

It is important to note that Yellow Card data cannot be used to derive side effect rates or compare the safety profile of COVID-19 vaccinations as many factors can influence ADR reporting.

For both vaccines, the overwhelming majority of reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as ‘flu-like’ illness, headache, chills, fatigue (tiredness), nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness.

These types of reactions reflect the normal immune response triggered by the body to the vaccines. They are typically seen with most types of vaccine and tend to resolve within a day or two. The nature of reported suspected side effects is broadly similar across age groups, although, as was seen in clinical trials and as is usually seen with other vaccines, they may be reported more frequently in younger adults.

Severe allergy

On 9 December 2020, the MHRA issued preliminary guidance on severe allergic reactions after the Pfizer/BioNTech vaccine due to early reports of anaphylaxis. Following further detailed review, this advice was amended on 30 December to the current advice. This advice is that people with a previous history of severe allergic reactions to any ingredients of the vaccine should not receive it. People who receive the vaccine should be monitored for at least 15 minutes afterwards.

Widespread use of the vaccine now suggests that severe allergic reactions to the Pfizer/BioNTech vaccine are very rare. Anaphylaxis can also be a very rare side effect associated with most other vaccines.

Following very substantial exposure across the UK population, no other new safety concerns have been identified from reports received so far.

Blood clots

Following a rigorous scientific review of all the available data, the available evidence does not suggest that blood clots in veins (venous thromboembolism) are caused by COVID-19 Vaccine AstraZeneca.

The MHRA’s advice remains that the benefits of the vaccines against COVID-19 continue to outweigh any risks and that the public should continue to get their vaccine when invited to do so.

Conclusion

• The increases in number of ADR reports reflects the increase in vaccine deployment as new vaccination centres have opened across the UK
• The number and nature of suspected adverse reactions reported so far are not unusual in comparison to other types of routinely used vaccines
• The overall safety experience with both vaccines is so far as expected from the clinical trials
• Based on current experience, the expected benefits of both COVID-19 vaccines in preventing COVID-19 and its serious complications far outweigh any known side effects
• As with all vaccines and medicines, the safety of COVID-19 vaccines is being continuously monitored

Further information on the type of suspected adverse reactions (ADRs) reported for the COVID-19 mRNA Pfizer/BioNTech vaccine and the COVID-19 Vaccine AstraZeneca is provided in Annex 1. It is important to read the guidance notes to ensure appropriate interpretation of the data.

1. Introduction

The MHRA is the executive Agency of the Department of Health and Social Care that acts to protect and promote public health and patient safety, by ensuring that medicines and medical devices meet appropriate standards of safety, quality and efficacy.

The MHRA operates the Yellow Card scheme on behalf of the Commission on Human Medicines (CHM). The scheme collects and monitors information on suspected safety concerns or incidents involving vaccines, medicines, medical devices, and e-cigarettes. The scheme relies on voluntary reporting of suspected adverse incidents by healthcare professionals and members of the public (patients, users, or carers). The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation. Further information about the Yellow Card scheme, including its contribution to identifying safety issues can be found on the Yellow Card website.

The MHRA has played an active role in responding to the coronavirus pandemic. In relation to COVID-19 vaccines, the MHRA has authorised their supply following a rigorous review of their safety, quality and efficacy. The clinical trials of COVID-19 vaccines have shown them to be effective and acceptably safe; however, as part of its statutory functions, the MHRA is responsible for monitoring these vaccines on an ongoing basis to ensure their benefits continue to outweigh any risks. This is a requirement for all authorised medicines and vaccines in the UK. This monitoring strategy is continuous, proactive and based on a wide range of information sources, with a dedicated team of scientists reviewing information daily to look for safety issues or unexpected rare events.

This report summarises information received via the Yellow Card scheme and will be published regularly to include other safety investigations carried out by the MHRA under the COVID-19 Vaccine Surveillance Strategy.

What is a Yellow Card?

The Yellow Card scheme is a mechanism by which anybody can voluntarily report any suspected adverse reactions or side effects to the vaccine. It is very important to note that a Yellow Card report does not necessarily mean the vaccine caused that reaction or event. We ask for any suspicions to be reported, even if the reporter isn’t sure if it was caused by the vaccine. Reports to the scheme are known as suspected adverse reactions (ADRs).

Many suspected ADRs reported on a Yellow Card do not have any relation to the vaccine or medicine and it is often coincidental that they both occurred around the same time. The reports are continually reviewed to detect possible new side effects that may require regulatory action, and to differentiate these from things that would have happened regardless of the vaccine or medicine being administered, for instance due to underlying or undiagnosed illness.

It is therefore important that the suspected ADRs described in this report are not interpreted as being proven side effects of COVID-19 vaccines. A list of the possible side effects of COVID-19 mRNA Pfizer/BioNTech and the COVID-19 Vaccine AstraZeneca is provided in the product information document for healthcare professionals and the UK recipient information. These can also be found on the Coronavirus Yellow Card reporting site.

This public summary provides an overview of all UK suspected ADRs associated with the new coronavirus (COVID-19) vaccines (COVID-19 mRNA Pfizer/BioNTech and COVID-19 Oxford University/AstraZeneca vaccine), and MHRA’s analysis of the data, between 9 December 2020 and 14 March 2021 (inclusive). A glossary of key terms is provided in Annex 2.

If identified, information on new and emerging safety concerns will be provided in future editions of this report together with details of any resulting regulatory action or changes to advice on use of the vaccines.

2. Yellow Card reports

Vaccine doses administered

Data from the UK Public Health agencies show that at least 24,453,221 people have received their first vaccination in the UK by week ending 14 March 2021, with 1,610,280 second doses administered. The current priority groups of the immunisation campaign include people over the age of 50 years, the clinically vulnerable, care home residents and workers, and frontline health and social care workers.

Table 1: Number of people who have received the first dose of a vaccination for COVID-19 in the UK between 8 December 2020 and end of 14 March 2021.

Country	Number of doses
England	20,791,838
Wales	1,122,931
Northern Ireland	629,461
Scotland	1,908,991

Table 2: Number of people who have received the second dose of a vaccination for COVID-19 in the UK between 8 December 2020 and end of 14 March 2021.

Country	Number of doses
England	1,129,444
Wales	264,255
Northern Ireland	54,636
Scotland	161,945

As of 14 March, an estimated 10.9 million first doses of the Pfizer/BioNTech vaccine and 13.7 million doses of the Oxford University/AstraZeneca vaccine, had been administered, and around 1.3 million second doses, mostly the Pfizer/BioNTech vaccine, had been administered.

The estimated number of doses administered differs from the estimated number of people vaccinated due to the different data sources used.

Yellow Card reporting trends

A report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the two vaccines. All reports are kept under continual review in order to identify possible new risks.

Up to and including 14 March 2021, the MHRA received and analysed 38,084 UK Yellow Cards from people who have received the COVID-19 mRNA Pfizer/BioNTech vaccine. These reports include a total of 108,649 suspected reactions (i.e. a single report may contain more than one symptom). The first report was received on 9 December 2020.

Up to and including 14 March 2021, the MHRA received and analysed a total of 78,223 UK reports of suspected ADRs to the COVID-19 Oxford University/AstraZeneca vaccine. These reports include a total of 294,820 suspected reactions (a single report may contain more than one symptom). The first report was received on 4 January 2021.

Additionally, up to and including 14 March 2021, the MHRA received 325 Yellow Card reports where the brand of vaccine was not specified by the reporter.

In the week since the previous summary for 07 March 2021 we have received a further 2,759 Yellow Cards for the Pfizer/BioNTech vaccine, 16,919 for the Oxford University/AstraZeneca vaccine and 44 where the brand was not specified. A higher number of doses of the Oxford University/AstraZeneca vaccine were administered in the last week than the Pfizer/BioNTech vaccine.

It is important to note that Yellow Card data cannot be used to derive side effect rates or compare the safety profile of COVID-19 vaccinations as many factors can influence ADR reporting.

Table 3: Number of suspected ADR reports received in the UK up to and including 14 March 2021.

	Number of reports	Number of reports	Number of reports
Country	Pfizer/ BioNtech	Oxford University/ AstraZeneca	Brand unspecified
England	30,343	69,427	172
Wales	2,308	2,840	18
Northern Ireland	736	665	3
Scotland	2,971	4,246	33

The figures in table 3 are based upon the postcode provided by the reporter. The sums of the reports in the table will not equal the total reports received for each vaccine as postcode may not have always been provided or may have been entered incorrectly. It is important to note that the number of reports received for each country does not directly equate to the number of people who may have experienced adverse reactions and therefore cannot be used to determine the incidence of reactions. ADR reporting rates are influenced by many aspects, including the extent of use.

We are working with public health bodies and encouraging all healthcare professionals and patients alike to report any suspected ADRs to the Yellow Card scheme. As expected, reports gradually increase in line with an increase in doses administered.

The overall reporting rate is in the order of 3 to 6 Yellow Cards per 1,000 doses administered for both vaccines. It is known from the clinical trials that the more common side effects for both vaccines can occur at a rate of more than one in 10 doses (for example, local reactions or symptoms resembling transient flu-like symptoms).

3. Analysis of data

One of MHRA’s main roles is to continually monitor safety of medicines and vaccines during widespread use, and we have in place a proactive strategy to do this for COVID-19 vaccines. We also work closely with our public health partners in reviewing the effectiveness and impact that the vaccines are having to ensure benefits continue to outweigh any possible side effects. In addition, we work with our international counterparts to gather information on the safety of vaccines in other countries.

Given the huge scale of the COVID-19 immunisation programme, with many millions of doses of vaccine administered over a relatively short time period, vigilance needs to be continuous, proactive and as near real-time as is possible. The importance of this is two-fold. First we need to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. We then can take any necessary action to minimise risks to individuals.

Secondly, we need to very quickly establish if any serious medical events which are temporally-related to vaccination are merely a coincidental association. These associations are likely while we are still in the midst of a national epidemic, and because most of the millions of people offered the vaccine in this early phase of a vaccination campaign are elderly and/or have underlying medical conditions, which increases the likelihood of unrelated illnesses occurring soon after vaccination. As mentioned above, the nature of Yellow Card reporting means that reported events are not always proven adverse reactions, and some may have happened regardless of vaccination.

Yellow Card reports of suspected ADRs are evaluated, together with additional sources of evidence, by a team of safety experts to identify any new safety issues or side effects. We apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of vaccination. This aims to account for factors such as coincidental illness. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern.

We supplement this form of safety monitoring with other epidemiology studies including analysis of data on national vaccine usage, anonymised GP-based electronic healthcare records and other healthcare data to proactively monitor safety. These combined safety data enable the MHRA to detect side effects or safety issues associated with COVID-19 vaccines. As well as confirming new risks, an equally important objective of monitoring will be to quickly rule out risks – in other words to confirm that the vaccine is not responsible for a suspected side effect and to provide reassurance on its safety and this is discussed below.

We also take into account the international experience based on data from other countries using the same vaccines.

Overall safety

As with any vaccine, the COVID-19 vaccines will cause side effects in some people. The total number and the nature of Yellow Cards reported so far is not unusual for a new vaccine for which members of the public and healthcare professionals are encouraged to report any suspected adverse reaction.

As highlighted above, it is known from the clinical trials that the most common side effects for both vaccines can occur at a rate of more than one per 10 doses (such as local reactions, symptoms resembling transient flu-like symptoms). Overall, Yellow Card reporting is therefore lower than the reporting rate of possible side effects from the clinical trials, although we generally do not expect all suspected side effects to be reported on Yellow Cards. The primary purpose of Yellow Card reporting is to detect new safety concerns.

For both vaccines, detailed review of all reports has found that the overwhelming majority relate to injection site reactions (sore arm for example) and generalised symptoms such as a ‘flu-like’ illness, headache, chills, fatigue (tiredness), nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness. These types of reaction reflect the acute immune response triggered by the body to the vaccines, are typically seen with most types of vaccine and tend to resolve within a day or two. The nature of reported suspected ADRs across all ages is broadly similar, although, as seen in the clinical trials and as is usually seen with other vaccines, they may be reported more frequently in younger adults.

As we receive more reports of these types of reactions with more exposure to the COVID-19 vaccines, we are building a picture of how individuals are experiencing them and the different ways that side effects may present in people. Some people have reported a sudden feeling of cold with shivering/shaking accompanied by a rise in temperature, often with sweating, headache (including migraine-like headaches), nausea, muscle aches and feeling unwell, starting within a day of having the vaccine. Similar to the flu like illness reported in clinical trials, these effects may last a day or two.

It is important to note that it is possible to have caught COVID-19 and not realise until after vaccination. If other COVID symptoms are experienced or fever is high and lasts longer than two or three days, vaccine recipients should stay at home and arrange to have a test.

Comments on specific reports

The following reports reflect data up to 14 March 2021. The glossary provides an explanation of the clinical terms used.

Anaphylaxis (Severe allergic reactions)

The MHRA continues to monitor reports of serious allergic reactions with the Pfizer/BioNTech COVID-19 vaccine and has received 237 UK spontaneous adverse reactions associated with anaphylaxis or anaphylactoid reactions. The nature and frequency of these reports is in line with that reported in previous updates, and severe allergic reactions to the Pfizer/BioNTech vaccine remain very rare. The MHRA’s guidance remains that those with a previous history of allergic reactions to the ingredients of the vaccine should not receive it.

The MHRA also closely monitors reports of anaphylaxis or anaphylactoid reactions with the AstraZeneca vaccine, and has received 326 UK spontaneous adverse reactions associated with anaphylaxis or anaphylactoid reactions reported, and is very rare. An update to the product information has been made to reflect the fact that cases of anaphylaxis have been reported for the AstraZeneca vaccine.

Bell’s Palsy

The MHRA continues to review cases reporting Bell’s Palsy and to analyse case reports against the number expected to occur by chance in the absence of vaccination (the ‘natural rate’). The number of reports of facial paralysis received so far is similar to the expected natural rate and does not currently suggest an increased risk following the vaccines. We will continue to monitor these events, including through evaluation of electronic healthcare record data.

Thrombo-embolic events

Following a rigorous scientific review of all the available data, the available evidence does not suggest that blood clots in veins (venous thromboembolism) are caused by COVID-19 Vaccine AstraZeneca. This follows a detailed review of reported cases as well as data from hospital admissions and GP records. This has been confirmed by the Government’s independent advisory group, the Commission on Human Medicines, whose expert scientists, and clinicians have also reviewed the available data.

A further, detailed review into UK reports of a very rare and specific type of blood clot in the cerebral veins (sinus vein thrombosis) occurring together with lowered platelets (thrombocytopenia) is ongoing. This has been reported in less than 1 in a million people vaccinated so far in the UK and can also occur naturally – a causal association with the vaccine has not been established.

The MHRA’s advice remains that the benefits of the vaccines against COVID-19 continue to outweigh any risks and that the public should continue to get their vaccine when invited to do so. For more information, see our statement.

Events with a fatal outcome

Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination. A high proportion of people vaccinated in the vaccination campaign so far are very elderly, many of whom will also have pre-existing medical conditions. Older age and chronic underlying illnesses make it more likely that coincidental adverse events will occur, especially given the millions of people vaccinated. It is therefore important that we carefully review these reports to distinguish possible side effects from illness that would have occurred irrespective of vaccination.

Part of our continuous analysis includes an evaluation of natural death rates over time, to determine if any specific trends or patterns are occurring that might indicate a vaccine safety concern. Based on age-stratified all-cause mortality in England and Wales taken from the Office for National Statistics death registrations, several thousand deaths are expected to have occurred, naturally, within 7 days of the many millions of doses of vaccines administered so far, mostly in the elderly.

The MHRA has received 259 UK reports of suspected ADRs to the Pfizer/BioNTech vaccine in which the patient died shortly after vaccination, 326 reports for the Oxford University/AstraZeneca vaccine and 9 where the brand of vaccine was unspecified. The majority of these reports were in elderly people or people with underlying illness. Usage of the AstraZeneca has increased rapidly and as such, so has reporting of fatal events with a temporal association with vaccination however, this does not indicate a link between vaccination and the fatalities reported. Review of individual reports and patterns of reporting does not suggest the vaccine played a role in the death.

4. Conclusion

At the time of this report, over 125,000 people across the UK have died within 28 days of a positive test for coronavirus. Rates of COVID-19 infection and hospitalisation remain high.

Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. A national immunisation campaign has been underway since early December 2020.

In clinical trials, the Pfizer/BioNTech and Oxford University/AstraZeneca COVID-19 vaccines have demonstrated very high levels of protection against symptomatic infection. We expect data to be available soon on the impact of the vaccination campaign in reducing infections and illness with COVID-19 in the UK.

All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness.

Following widespread use of these vaccines across the UK, the vast majority of suspected adverse reaction reports so far confirm the safety profile seen in clinical trials. Most reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as a ‘flu-like’ illness, headache, chills, fatigue, nausea, fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these reactions are not associated with more serious illness and likely reflect an expected, normal immune response to the vaccines.

Following very substantial exposure across the UK population, no other new safety concerns have been identified from reports received to date, and for the cases of other medical conditions reported in temporal association with vaccination, the available evidence does not currently suggest that the vaccine caused the event.

The overall safety experience with both vaccines is so far as expected from the clinical trials. The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is a continuously monitored and benefits and possible risks remain under review.

We take every report of a suspected ADR seriously and encourage everyone to report through the Yellow Card scheme.

Annex 1: Vaccine Analysis Print

The attached Vaccine Analysis Profile contains a complete listing of all suspected adverse reactions or that have been reported to the MHRA via the Yellow Card scheme for the COVID-19 mRNA Pfizer/BioNTech vaccine. This includes all reports received from healthcare professionals, members of the public, and pharmaceutical companies.

This information does not represent an overview of the potential side effects associated with the vaccines. A list of the recognised adverse effects of COVID-19 vaccines is provided in the information for healthcare professionals and the recipient information here. These can also be found on the Coronavirus Yellow Card reporting site. Conclusions on the safety and risks of the vaccines cannot be made on the data shown in the Print alone.

When viewing the vaccine analysis print you should remember that:

• Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the medicine may have caused the adverse reaction. The existence of an adverse reaction report in the print does not necessarily mean that the vaccine has caused the suspected reaction.
• It may be difficult to tell the difference between something that has occurred naturally and a suspected adverse reaction. Sometimes these events can be part of the condition being treated rather than being caused by the vaccine.
• Many factors have to be considered when assessing whether the vaccine has caused a reported adverse reaction. When monitoring the safety of vaccines and medicines, MHRA staff carry out careful analysis of these factors.

For a medicine or vaccine to be considered safe, the expected benefits will be greater than the risk of having harmful reactions. It is important to note that most people take medicines and vaccines without having any serious side effects.

Vaccine Analysis Profile - Pfizer/BioNTech

Vaccine Analysis Profile - Oxford University/AstraZeneca

Vaccine Analytics Profile - brand unspecified

Annex 2 Glossary

Anaphylaxis or anaphylactoid reactions

Anaphylaxis is a severe and potentially life-threatening allergic reaction. These reactions can occur after an exposure to a trigger, such as a certain ingredient in foods or medicines or an insect sting. Anaphylaxis and anaphylactoid reactions can be treated with adrenaline.

Bell’s palsy

Bell’s palsy is a condition that causes temporary weakness or paralysis (lack of movement) of the muscles in one side of the face. It is the most common cause of facial paralysis. For most people, the facial paralysis is temporary. Viral infections such as those with herpes viruses have been linked to Bell’s palsy.

Clinical Practice Research Datalink (CPRD)

Clinical Practice Research Datalink (CPRD) is a real-world research service to support public health and clinical studies. CPRD is jointly sponsored by the Medicines and Healthcare products Regulatory Agency and the National Institute for Health Research (NIHR), as part of the Department of Health and Social Care. CPRD collects anonymised patient data from a network of GP practices across the UK.

Commission on Human Medicines (CHM)

The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. For COVID-19 vaccines, the CHM has a COVID-19 Vaccines Safety Surveillance Methodologies Expert Working Group and a COVID-19 Vaccines Benefit Risk Expert Working Group.

Epidemiology studies

Epidemiological studies include large numbers of people and are designed to compare the risk of a particular event in an exposed population, in this case those who have received a vaccine, to those who have not. They attempt to account for differences in the different groups to help us understand if any difference in risk is caused by the exposure. Epidemiological studies measure the risk of illness or death in an exposed population compared to that risk in an identical, unexposed population.

Regulation 174 authorisation

Temporary authorisation for supply of a medicine or vaccine by the UK Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency. This temporary authorisation grants permission for a medicine (vaccine) to be used for active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus. Authorisation is subject to a number of conditions. These are available for each vaccine on the MHRA website.

Suspected adverse reactions

Also known as side effects. All medicines or vaccines can cause adverse reactions in some people. Adverse drug reactions reported to the MHRA are looked at and used to assess the balance of risks and benefits of medicines and vaccines.

Temporal Association

Events occurring following vaccination but may or may not be caused by the vaccine.

Yellow Card scheme

The MHRA’s scheme for healthcare professionals and members of the public to report suspected adverse reactions for a medicine or vaccine, as well as medical devices and other products. The dedicated Coronavirus Yellow Card reporting site was launched in May 2020 specifically for medicines and medical devices used in COVID-19, as well as COVID-19 vaccines when authorised.

[ransomnote]

I was waiting for your thread before I post my thread on that lesser link you didn't want to use. Does that sound okay? Here's the content - let me know what you think.

---

Thank you to Fractal Trader for finding the linked information.

Fractal Trader is going to post the original UK.gov data upon which the story I'll link and describe below was based.

I'm going to post some information from the article Fractal Trader found first, and decided not to post, while tracing the path back to the UK.GOV article f.

I am not familiar with the the website and 'expose' in the title of the blog doesn't ensure validity, but we report data from official sources, too).

The article content I'm sharing did link to the UK.gov report Fractal will post, and references data in the UK version of standard CDC VAERS type software.( I've reviewed data in the CDC's VAERS and found reports of lost pregnancies.)

It's important to know that since the 'vaccines' are just being introduced these past few months, the overall numbers of lost pregnancies are very low, but they are so much higher than normal (percentage increase), it's likely to increase rapidly as more receive it. Often in animal trials negative effects start showing up 3 - 6 months after 'vaccination'.

I'll post some CDC snippets below and summarize a few the article comments where relevant.

~~~~~~~~~~~~~~~~

The author wondered why pregnanant women were receiving the 'shots' in the first place, since the UK government had advised against it.

Here's an excerpt: 

Number of women to lose their unborn child after having the Covid Vaccine increases by 366% in just six weeks – The Daily Expose

 BY THE DAILY EXPOSE ON MARCH 21, 2021 • ( 26 COMMENTS )

Well we started digging and found that the Government has since updated it’s original advice to the following –

4.6 Fertility, pregnancy and lactation
Pregnancy
There is limited experience with use of the COVID-19 mRNA Vaccine BNT162b2 in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy,
embryo/foetal development, parturition or post-natal development. Administration of
the COVID-19 mRNA Vaccine BNT162b2 in pregnancy should only be considered when the potential
benefits outweigh any potential risks for the mother and foetus.

~~~~~~~~~~~~~~~~~~~

Ah, the old risk vs. benefits excuse to recommend the fake vaccines. Particularly galling because all risk information is suppressed.

I'll reword the author's text around the charts so I don't have to keep quoting. 

Data inputted to the MHRA Yellow Card Scheme up to the 24th January 2021 a total of 4 women had suffered a miscarriage as a result of having the Pfizer/BioNTech vaccine.

As well as a total of 2 women losing their unborn child as result of having the Oxford/AstraZeneca vaccine.

The author notes the government advised against giving the vaccine to pregnant women, but still the vaccine was administered. The same is true in the US. Pregnant women are advised not to get the 'vaccine' but there are lost pregnancies.

Between January 24, 2021 and March 7th, there has been a 475% increase  in the number of women who have lost their unborn child after having the Pfizer vaccine, bringing the total to 23. This is devastating.

Sadly there's 1 report of a premature baby dying after the mother had the Pfizer vaccine. This could have happened as a result of other factors, but we need to watch and take note to try to head off any negative patterns for further investigation. 

I understand that this is observed data (they noted when the vaccine was given, and when the event occured) and not causal data (the result of years of biomedical analysis to determine if other factors were entirely or partly responsible for the event), but we best make use of what we observe because it's all we have right now. The CDC and Co. are steering us onto the rocks.

The AstraZeneca 'shot' is also reported to have observations of lost pregnancy events. Between January 24, 2021 and March 7th, there has been a 150% increase  in the number of women to suffer a miscarriage, bringing the total to 5.

Unfortunately, 1 still birth was reported to the MHRA Yellow Card Scheme after the mother had the AstraZeneca vaccine, but for some reason this has not been labelled as a fatality

 

Well we started digging and found that the Government has since updated it’s original advice to the following –

4.6 Fertility, pregnancy and lactation
Pregnancy
There is limited experience with use of the COVID-19 mRNA Vaccine BNT162b2 in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy,
embryo/foetal development, parturition or post-natal development. Administration of
the COVID-19 mRNA Vaccine BNT162b2 in pregnancy should only be considered when the potential
benefits outweigh any potential risks for the mother and foetus.

~~~~~~~~~~~~~~~

Below is a screen capture of the CDC's advice (3/29/2021) to pregnant women in the United States. Note the CDC defers to a pregnant woman's 'personal choice' whether or not to get the 'vaccine'. Isn't that favoritism in the work place requiring employees to get the 'vaccine'. ( I DON'T WANT ANYONE TO GET THE VACCINE. My comment about favoritism is a play on the Woke-ism driving people from employment)

Information about COVID-19 Vaccines for People who Are Pregnant or Breastfeeding | CDC

Here's an image originally linked by defconw in a prior post.

The above image was taken from FReeper defconw's link to a large .jpg collection of social media posts detailing negative experiences. I dont' recall if there was more than one from a pregnant woman, and again, these are just observations, not the results of 10 years of medical study. It does show an example of a pregnant woman who, encouraged to consider the risks and benefits by the content on the CDC's website, decided she should get the vaccine.

The following post includes defconw's montage of all the images in one image file (.jpg). Below her link, I broke the images up into smaller pieces which can be read in a single column.

https://freerepublic.com/focus/chat/3942345/posts?page=1999#1999 (freerepublic.com)

 I am a skeptic; I doubt pregnant women are being sufficiently informed of the risks (example below)

Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease

3/29/2021, 12:01:38 PM · by ransomnote · 19 replies

onlinelibrary.wiley.com ^ | October 20, 2020 | Ronald Veazy, Timothy Cardozo

 

I'm even more skeptical that parents are being sufficiently informed of the risks:

 

Shots in little arms: COVID-19 vaccine testing turns to kids
kstp.com ^ | March 24, 2021 | kstp.com, ABC

Posted on 3/28/2021, 5:44:31 AM

[ransomnote]

I don’t know why we have different results. I will whack off that part - I think I did initially so maybe I dropped a character or two from the html when I cut/past it back and then my browser is ‘forgiving it’ but others might not.

Let’s try this again. *runs to go modify/post HTML*

[Fractal Trader]

It’s fixed now 2189

[Fractal Trader]

oops — 2195

[ransomnote]

<div class="gem-c-contextual-breadcrumbs">&nbsp;</div>
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<h1 class="gem-c-title__text ">Coronavirus vaccine - weekly summary of Yellow Card reporting</h1>
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<p class="publication-header__last-changed">Updated 25 March 2021</p>
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<li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--numbered"><a class="gem-c-contents-list__link govuk-link " href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#summary" data-track-category="contentsClicked" data-track-action="content_item 1" data-track-label="#summary" data-track-options="{&quot;dimension29&quot;:&quot;Summary&quot;}">Summary</a></li>
<li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--numbered"><a class="gem-c-contents-list__link govuk-link " href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#introduction" data-track-category="contentsClicked" data-track-action="content_item 2" data-track-label="#introduction" data-track-options="{&quot;dimension29&quot;:&quot;\n1. Introduction&quot;}"><span class="gem-c-contents-list__number">1.</span><span class="gem-c-contents-list__numbered-text">Introduction</span></a></li>
<li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--numbered"><a class="gem-c-contents-list__link govuk-link " href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#yellow-card-reports" data-track-category="contentsClicked" data-track-action="content_item 3" data-track-label="#yellow-card-reports" data-track-options="{&quot;dimension29&quot;:&quot;\n2. Yellow Card reports&quot;}"><span class="gem-c-contents-list__number">2.</span><span class="gem-c-contents-list__numbered-text">Yellow Card reports</span></a></li>
<li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--numbered"><a class="gem-c-contents-list__link govuk-link " href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#analysis-of-data" data-track-category="contentsClicked" data-track-action="content_item 4" data-track-label="#analysis-of-data" data-track-options="{&quot;dimension29&quot;:&quot;\n3. Analysis of data&quot;}"><span class="gem-c-contents-list__number">3.</span><span class="gem-c-contents-list__numbered-text">Analysis of data</span></a></li>
<li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--numbered"><a class="gem-c-contents-list__link govuk-link " href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#conclusion-1" data-track-category="contentsClicked" data-track-action="content_item 5" data-track-label="#conclusion-1" data-track-options="{&quot;dimension29&quot;:&quot;\n4. Conclusion&quot;}"><span class="gem-c-contents-list__number">4.</span><span class="gem-c-contents-list__numbered-text">Conclusion</span></a></li>
<li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--numbered"><a class="gem-c-contents-list__link govuk-link " href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#annex-1-vaccine-analysis-print" data-track-category="contentsClicked" data-track-action="content_item 6" data-track-label="#annex-1-vaccine-analysis-print" data-track-options="{&quot;dimension29&quot;:&quot;Annex 1: Vaccine Analysis Print&quot;}">Annex 1: Vaccine Analysis Print</a></li>
<li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--numbered"><a class="gem-c-contents-list__link govuk-link " href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#annex-2-glossary" data-track-category="contentsClicked" data-track-action="content_item 7" data-track-label="#annex-2-glossary" data-track-options="{&quot;dimension29&quot;:&quot;Annex 2 Glossary&quot;}">Annex 2 Glossary</a></li>
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<p>This report covers the period 9 December 2020 to 14 March 2021.</p>
<h2 id="summary">Summary</h2>
<p>At the time of this report, over 125,000 people across the UK have died within 28 days of a positive test for coronavirus (COVID-19).&nbsp;<a class="govuk-link" href="https://coronavirus.data.gov.uk/" rel="external">Rates of COVID-19 infection and hospitalisation</a>&nbsp;remain high.</p>
<p>Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. A national immunisation campaign has been underway since early December 2020.</p>
<p>Two COVID-19 vaccines, Pfizer/BioNTech and Oxford University/AstraZeneca vaccines, are currently being used in the UK. Both have been authorised for supply by the Medicines and Healthcare products Regulatory Agency (MHRA) following a thorough review of safety, quality and efficacy information from clinical trials. In&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/collections/mhra-guidance-on-coronavirus-covid-19#vaccines-and-vaccine-safety">clinical trials</a>, both vaccines showed very high levels of protection against symptomatic infections with COVID-19. We expect data to be available soon on the impact of the vaccination campaign in reducing infections and illness in the UK.</p>
<p>All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness.</p>
<p>The Pfizer/BioNTech vaccine was evaluated in clinical trials involving more than 44,000 participants. The most&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/information-for-healthcare-professionals-on-pfizerbiontech-covid-19-vaccine">frequent adverse reactions</a>&nbsp;in trials were pain at the injection site, fatigue, headache, myalgia (muscle pains), chills, arthralgia (joint pains), and fever; these were each reported in more than 1 in 10 people. These reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Adverse reactions were reported less frequently in older adults (over 55 years) than in younger people.</p>
<p>The Oxford University/AstraZeneca vaccine was evaluated in clinical trials involving more than 23,000 participants. The most&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/information-for-healthcare-professionals-on-covid-19-vaccine-astrazeneca">frequently reported adverse reactions</a>&nbsp;in these trials were injection-site tenderness, injection-site pain, headache, fatigue, myalgia, malaise, pyrexia (fever), chills, arthralgia, and nausea; these were each reported in more than 1 in 10 people. The majority of adverse reactions were mild to moderate in severity and usually resolved within a few days of vaccination. Adverse reactions reported after the second dose were milder and reported less frequently than after the first dose. Adverse reactions were generally milder and reported less frequently in older adults (65 years and older) than in younger people.</p>
<p>The MHRA&rsquo;s role is also to continually monitor safety during widespread use of a vaccine. We have in place a&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance">proactive strategy to do this</a>. We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects.</p>
<p>Part of our monitoring role includes reviewing reports of suspected side effects. Any member of the public or health professional can submit suspected side effects through the&nbsp;<a class="govuk-link" href="https://yellowcard.mhra.gov.uk/" rel="external">Yellow Card scheme</a>. The nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated, and especially when most vaccines are being given to the most elderly people and people who have underlying illness.</p>
<p>This safety update report is based on detailed analysis of data up to 14 March 2021. At this date, an estimated 10.9 million first doses of the Pfizer/BioNTech vaccine and 13.7 million doses of the Oxford University/AstraZeneca vaccine had been administered, and around 1.3 million second doses, mostly the Pfizer/BioNTech vaccine, had been administered. This represents an increase of 2.3 million on the previous week, predominately Oxford University/AstraZeneca vaccine.</p>
<p>As of 14 March 2021, for the UK, 38,084 Yellow Cards have been reported for the Pfizer/BioNTech, 78,223 have been reported for the Oxford University/AstraZeneca vaccine, and 325 have been reported where the brand of the vaccine was not specified.</p>
<p>For both vaccines the overall reporting rate is around 3 to 6 Yellow Cards per 1,000 doses administered.</p>
<p>In the week since the previous summary for 07 March 2021 we have received a further 2,759 Yellow Cards for the Pfizer/BioNTech vaccine, 16,919 for the Oxford University/AstraZeneca vaccine and 44 where the brand was not specified. A higher number of doses of the Oxford University/AstraZeneca vaccine were administered in the last week than the Pfizer/BioNTech vaccine.</p>
<p>It is important to note that Yellow Card data cannot be used to derive side effect rates or compare the safety profile of COVID-19 vaccinations as many factors can influence ADR reporting.</p>
<p>For both vaccines, the overwhelming majority of reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as &lsquo;flu-like&rsquo; illness, headache, chills, fatigue (tiredness), nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness.</p>
<p>These types of reactions reflect the normal immune response triggered by the body to the vaccines. They are typically seen with most types of vaccine and tend to resolve within a day or two. The nature of reported suspected side effects is broadly similar across age groups, although, as was seen in clinical trials and as is usually seen with other vaccines, they may be reported more frequently in younger adults.</p>
<h3 id="severe-allergy">Severe allergy</h3>
<p>On 9 December 2020, the MHRA issued preliminary guidance on severe allergic reactions after the Pfizer/BioNTech vaccine due to early reports of anaphylaxis. Following further detailed review, this advice was amended on 30 December to the&nbsp;<a class="govuk-link" href="https://www.gov.uk/drug-safety-update/covid-19-vaccines-pfizer-slash-biontech-and-covid-19-vaccine-astrazeneca-current-advice">current advice</a>. This advice is that people with a previous history of severe allergic reactions to any ingredients of the vaccine should not receive it. People who receive the vaccine should be monitored for at least 15 minutes afterwards.</p>
<p>Widespread use of the vaccine now suggests that severe allergic reactions to the Pfizer/BioNTech vaccine are very rare. Anaphylaxis can also be a very rare side effect associated with most other vaccines.</p>
<p>Following very substantial exposure across the UK population, no other new safety concerns have been identified from reports received so far.</p>
<h3 id="blood-clots">Blood clots</h3>
<p>Following a rigorous scientific review of all the available data, the available evidence does not suggest that blood clots in veins (venous thromboembolism) are caused by COVID-19 Vaccine AstraZeneca.</p>
<p><a class="govuk-link" href="https://www.gov.uk/government/news/uk-regulator-confirms-that-people-should-continue-to-receive-the-covid-19-vaccine-astrazeneca">The MHRA&rsquo;s advice remains that the benefits of the vaccines against COVID-19 continue to outweigh any risks</a>&nbsp;and that the public should continue to get their vaccine when invited to do so.</p>
<h3 id="conclusion">Conclusion</h3>
<ul>
<li>The increases in number of ADR reports reflects the increase in vaccine deployment as new vaccination centres have opened across the UK</li>
<li>The number and nature of suspected adverse reactions reported so far are not unusual in comparison to other types of routinely used vaccines</li>
<li>The overall safety experience with both vaccines is so far as expected from the clinical trials</li>
<li>Based on current experience, the expected benefits of both COVID-19 vaccines in preventing COVID-19 and its serious complications far outweigh any known side effects</li>
<li>As with all vaccines and medicines, the safety of COVID-19 vaccines is being continuously monitored</li>
</ul>
<p>Further information on the type of suspected adverse reactions (ADRs) reported for the COVID-19 mRNA Pfizer/BioNTech vaccine and the COVID-19 Vaccine AstraZeneca is provided in Annex 1. It is important to read the guidance notes to ensure appropriate interpretation of the data.</p>
<h2 id="introduction"><span class="number">1.&nbsp;</span>Introduction</h2>
<p>The MHRA is the executive Agency of the Department of Health and Social Care that acts to protect and promote public health and patient safety, by ensuring that medicines and medical devices meet appropriate standards of safety, quality and efficacy.</p>
<p>The MHRA operates the&nbsp;<a class="govuk-link" href="https://yellowcard.mhra.gov.uk/" rel="external">Yellow Card scheme</a>&nbsp;on behalf of the Commission on Human Medicines (CHM). The scheme collects and monitors information on suspected safety concerns or incidents involving vaccines, medicines, medical devices, and e-cigarettes. The scheme relies on voluntary reporting of suspected adverse incidents by healthcare professionals and members of the public (patients, users, or carers). The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation. Further information about the Yellow Card scheme, including its contribution to identifying safety issues can be found on the&nbsp;<a class="govuk-link" href="https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/" rel="external">Yellow Card website</a>.</p>
<p>The MHRA has played an active role in responding to the coronavirus pandemic. In relation to COVID-19 vaccines, the MHRA has authorised their supply following a rigorous review of their safety, quality and efficacy. The clinical trials of COVID-19 vaccines have shown them to be effective and acceptably safe; however, as part of its statutory functions, the MHRA is responsible for monitoring these vaccines on an ongoing basis to ensure their benefits continue to outweigh any risks. This is a requirement for all authorised medicines and vaccines in the UK. This monitoring strategy is continuous, proactive and based on a wide range of information sources, with a dedicated team of scientists reviewing information daily to look for safety issues or unexpected rare events.</p>
<p>This report summarises information received via the Yellow Card scheme and will be published regularly to include other safety investigations carried out by the MHRA under the&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance">COVID-19 Vaccine Surveillance Strategy</a>.</p>
<h3 id="what-is-a-yellow-card">What is a Yellow Card?</h3>
<p>The Yellow Card scheme is a mechanism by which anybody can voluntarily report any suspected adverse reactions or side effects to the vaccine. It is very important to note that a Yellow Card report does not necessarily mean the vaccine caused that reaction or event. We ask for any suspicions to be reported, even if the reporter isn&rsquo;t sure if it was caused by the vaccine. Reports to the scheme are known as suspected adverse reactions (ADRs).</p>
<p>Many suspected ADRs reported on a Yellow Card do not have any relation to the vaccine or medicine and it is often coincidental that they both occurred around the same time. The reports are continually reviewed to detect possible new side effects that may require regulatory action, and to differentiate these from things that would have happened regardless of the vaccine or medicine being administered, for instance due to underlying or undiagnosed illness.</p>
<p>It is therefore important that the suspected ADRs described in this report are not interpreted as being proven side effects of COVID-19 vaccines. A list of the possible side effects of&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19">COVID-19 mRNA Pfizer/BioNTech</a>&nbsp;and the&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca">COVID-19 Vaccine AstraZeneca</a>&nbsp;is provided in the product information document for healthcare professionals and the UK recipient information. These can also be found on the&nbsp;<a class="govuk-link" href="https://coronavirus-yellowcard.mhra.gov.uk/" rel="external">Coronavirus Yellow Card reporting site</a>.</p>
<p>This public summary provides an overview of all UK suspected ADRs associated with the new coronavirus (COVID-19) vaccines (COVID-19 mRNA Pfizer/BioNTech and COVID-19 Oxford University/AstraZeneca vaccine), and MHRA&rsquo;s analysis of the data, between 9 December 2020 and 14 March 2021 (inclusive). A glossary of key terms is provided in Annex 2.</p>
<p>If identified, information on new and emerging safety concerns will be provided in future editions of this report together with details of any resulting regulatory action or changes to advice on use of the vaccines.</p>
<h2 id="yellow-card-reports"><span class="number">2.&nbsp;</span>Yellow Card reports</h2>
<h3 id="vaccine-doses-administered">Vaccine doses administered</h3>
<p>Data from the UK&nbsp;<a class="govuk-link" href="https://coronavirus.data.gov.uk/details/vaccinations" rel="external">Public Health agencies</a>&nbsp;show that at least 24,453,221 people have received their first vaccination in the UK by week ending 14 March 2021, with 1,610,280 second doses administered. The current priority groups of the immunisation campaign include people over the age of 50 years, the clinically vulnerable, care home residents and workers, and frontline health and social care workers.</p>
<h3 id="table-1-number-of-people-who-have-received-the-first-dose-of-a-vaccination-for-covid-19-in-the-uk-between-8-december-2020-and-end-of-14-march-2021">Table 1: Number of people who have received the first dose of a vaccination for COVID-19 in the UK between 8 December 2020 and end of 14 March 2021.</h3>
<table>
<thead>
<tr>
<th scope="col">Country</th>
<th scope="col">Number of doses</th>
</tr>
</thead>
<tbody>
<tr>
<td>England</td>
<td>20,791,838</td>
</tr>
<tr>
<td>Wales</td>
<td>1,122,931</td>
</tr>
<tr>
<td>Northern Ireland</td>
<td>629,461</td>
</tr>
<tr>
<td>Scotland</td>
<td>1,908,991</td>
</tr>
</tbody>
</table>
<h3 id="table-2-number-of-people-who-have-received-the-second-dose-of-a-vaccination-for-covid-19-in-the-uk-between-8-december-2020-and-end-of-14-march-2021">Table 2: Number of people who have received the second dose of a vaccination for COVID-19 in the UK between 8 December 2020 and end of 14 March 2021.</h3>
<table>
<thead>
<tr>
<th scope="col">Country</th>
<th scope="col">Number of doses</th>
</tr>
</thead>
<tbody>
<tr>
<td>England</td>
<td>1,129,444</td>
</tr>
<tr>
<td>Wales</td>
<td>264,255</td>
</tr>
<tr>
<td>Northern Ireland</td>
<td>54,636</td>
</tr>
<tr>
<td>Scotland</td>
<td>161,945</td>
</tr>
</tbody>
</table>
<p>As of 14 March, an estimated 10.9 million first doses of the Pfizer/BioNTech vaccine and 13.7 million doses of the Oxford University/AstraZeneca vaccine, had been administered, and around 1.3 million second doses, mostly the Pfizer/BioNTech vaccine, had been administered.</p>
<p>The estimated number of doses administered differs from the estimated number of people vaccinated due to the different data sources used.</p>
<h3 id="yellow-card-reporting-trends">Yellow Card reporting trends</h3>
<p>A report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the two vaccines. All reports are kept under continual review in order to identify possible new risks.</p>
<p>Up to and including 14 March 2021, the MHRA received and analysed 38,084 UK Yellow Cards from people who have received the COVID-19 mRNA Pfizer/BioNTech vaccine. These reports include a total of 108,649 suspected reactions (i.e. a single report may contain more than one symptom). The first report was received on 9 December 2020.</p>
<p>Up to and including 14 March 2021, the MHRA received and analysed a total of 78,223 UK reports of suspected ADRs to the COVID-19 Oxford University/AstraZeneca vaccine. These reports include a total of 294,820 suspected reactions (a single report may contain more than one symptom). The first report was received on 4 January 2021.</p>
<p>Additionally, up to and including 14 March 2021, the MHRA received 325 Yellow Card reports where the brand of vaccine was not specified by the reporter.</p>
<p>In the week since the previous summary for 07 March 2021 we have received a further 2,759 Yellow Cards for the Pfizer/BioNTech vaccine, 16,919 for the Oxford University/AstraZeneca vaccine and 44 where the brand was not specified. A higher number of doses of the Oxford University/AstraZeneca vaccine were administered in the last week than the Pfizer/BioNTech vaccine.</p>
<p>It is important to note that Yellow Card data cannot be used to derive side effect rates or compare the safety profile of COVID-19 vaccinations as many factors can influence ADR reporting.</p>
<h3 id="table-3-number-of-suspected-adr-reports-received-in-the-uk-up-to-and-including-14-march-2021">Table 3: Number of suspected ADR reports received in the UK up to and including 14 March 2021.</h3>
<table>
<thead>
<tr>
<td>&nbsp;</td>
<th scope="col">Number of reports</th>
<th scope="col">Number of reports</th>
<th scope="col">Number of reports</th>
</tr>
<tr>
<th scope="col">Country</th>
<th scope="col">Pfizer/ BioNtech</th>
<th scope="col">Oxford University/ AstraZeneca</th>
<th scope="col">Brand unspecified</th>
</tr>
</thead>
<tbody>
<tr>
<td>England</td>
<td>30,343</td>
<td>69,427</td>
<td>172</td>
</tr>
<tr>
<td>Wales</td>
<td>2,308</td>
<td>2,840</td>
<td>18</td>
</tr>
<tr>
<td>Northern Ireland</td>
<td>736</td>
<td>665</td>
<td>3</td>
</tr>
<tr>
<td>Scotland</td>
<td>2,971</td>
<td>4,246</td>
<td>33</td>
</tr>
</tbody>
</table>
<p>The figures in table 3 are based upon the postcode provided by the reporter. The sums of the reports in the table will not equal the total reports received for each vaccine as postcode may not have always been provided or may have been entered incorrectly. It is important to note that the number of reports received for each country does not directly equate to the number of people who may have experienced adverse reactions and therefore cannot be used to determine the incidence of reactions. ADR reporting rates are influenced by many aspects, including the extent of use.</p>
<p>We are working with public health bodies and encouraging all healthcare professionals and patients alike to report any suspected ADRs to the Yellow Card scheme. As expected, reports gradually increase in line with an increase in doses administered.</p>
<p>The overall reporting rate is in the order of 3 to 6 Yellow Cards per 1,000 doses administered for both vaccines. It is known from the clinical trials that the more common side effects for both vaccines can occur at a rate of more than one in 10 doses (for example, local reactions or symptoms resembling transient flu-like symptoms).</p>
<h2 id="analysis-of-data"><span class="number">3.&nbsp;</span>Analysis of data</h2>
<p>One of MHRA&rsquo;s main roles is to continually monitor safety of medicines and vaccines during widespread use, and we have in place a&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance">proactive strategy to do this</a>&nbsp;for COVID-19 vaccines. We also work closely with our public health partners in reviewing the effectiveness and impact that the vaccines are having to ensure benefits continue to outweigh any possible side effects. In addition, we work with our international counterparts to gather information on the safety of vaccines in other countries.</p>
<p>Given the huge scale of the COVID-19 immunisation programme, with many millions of doses of vaccine administered over a relatively short time period, vigilance needs to be continuous, proactive and as near real-time as is possible. The importance of this is two-fold. First we need to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. We then can take any necessary action to minimise risks to individuals.</p>
<p>Secondly, we need to very quickly establish if any serious medical events which are temporally-related to vaccination are merely a coincidental association. These associations are likely while we are still in the midst of a national epidemic, and because most of the millions of people offered the vaccine in this early phase of a vaccination campaign are elderly and/or have underlying medical conditions, which increases the likelihood of unrelated illnesses occurring soon after vaccination. As mentioned above, the nature of Yellow Card reporting means that reported events are not always proven adverse reactions, and some may have happened regardless of vaccination.</p>
<p>Yellow Card reports of suspected ADRs are evaluated, together with additional sources of evidence, by a team of safety experts to identify any new safety issues or side effects. We apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of vaccination. This aims to account for factors such as coincidental illness. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern.</p>
<p>We supplement this form of safety monitoring with other epidemiology studies including analysis of data on national vaccine usage, anonymised GP-based electronic healthcare records and other healthcare data to proactively monitor safety. These combined safety data enable the MHRA to detect side effects or safety issues associated with COVID-19 vaccines. As well as confirming new risks, an equally important objective of monitoring will be to quickly rule out risks &ndash; in other words to confirm that the vaccine is not responsible for a suspected side effect and to provide reassurance on its safety and this is discussed below.</p>
<p>We also take into account the international experience based on data from other countries using the same vaccines.</p>
<h3 id="overall-safety">Overall safety</h3>
<p>As with any vaccine, the COVID-19 vaccines will cause side effects in some people. The total number and the nature of Yellow Cards reported so far is not unusual for a new vaccine for which members of the public and healthcare professionals are encouraged to report any suspected adverse reaction.</p>
<p>As highlighted above, it is known from the clinical trials that the most common side effects for both vaccines can occur at a rate of more than one per 10 doses (such as local reactions, symptoms resembling transient flu-like symptoms). Overall, Yellow Card reporting is therefore lower than the reporting rate of possible side effects from the clinical trials, although we generally do not expect all suspected side effects to be reported on Yellow Cards. The primary purpose of Yellow Card reporting is to detect new safety concerns.</p>
<p>For both vaccines, detailed review of all reports has found that the overwhelming majority relate to injection site reactions (sore arm for example) and generalised symptoms such as a &lsquo;flu-like&rsquo; illness, headache, chills, fatigue (tiredness), nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness. These types of reaction reflect the acute immune response triggered by the body to the vaccines, are typically seen with most types of vaccine and tend to resolve within a day or two. The nature of reported suspected ADRs across all ages is broadly similar, although, as seen in the clinical trials and as is usually seen with other vaccines, they may be reported more frequently in younger adults.</p>
<p>As we receive more reports of these types of reactions with more exposure to the COVID-19 vaccines, we are building a picture of how individuals are experiencing them and the different ways that side effects may present in people. Some people have reported a sudden feeling of cold with shivering/shaking accompanied by a rise in temperature, often with sweating, headache (including migraine-like headaches), nausea, muscle aches and feeling unwell, starting within a day of having the vaccine. Similar to the flu like illness reported in clinical trials, these effects may last a day or two.</p>
<p>It is important to note that it is possible to have caught COVID-19 and not realise until after vaccination. If other COVID symptoms are experienced or fever is high and lasts longer than two or three days, vaccine recipients should stay at home and arrange to have a test.</p>
<h3 id="glossary">Comments on specific reports</h3>
<p>The following reports reflect data up to 14 March 2021. The glossary provides an explanation of the clinical terms used.</p>
<h3 id="anaphylaxis-severe-allergic-reactions">Anaphylaxis (Severe allergic reactions)</h3>
<p>The MHRA continues to monitor reports of serious allergic reactions with the Pfizer/BioNTech COVID-19 vaccine and has received 237 UK spontaneous adverse reactions associated with anaphylaxis or anaphylactoid reactions. The nature and frequency of these reports is in line with that reported in previous updates, and severe allergic reactions to the Pfizer/BioNTech vaccine remain very rare. The MHRA&rsquo;s guidance remains that those with a previous history of allergic reactions to the ingredients of the vaccine should not receive it.</p>
<p>The MHRA also closely monitors reports of anaphylaxis or anaphylactoid reactions with the AstraZeneca vaccine, and has received 326 UK spontaneous adverse reactions associated with anaphylaxis or anaphylactoid reactions reported, and is very rare. An update to the product information has been made to reflect the fact that cases of anaphylaxis have been reported for the AstraZeneca vaccine.</p>
<h3 id="bells-palsy">Bell&rsquo;s Palsy</h3>
<p>The MHRA continues to review cases reporting Bell&rsquo;s Palsy and to analyse case reports against the number expected to occur by chance in the absence of vaccination (the &lsquo;natural rate&rsquo;). The number of reports of facial paralysis received so far is similar to the expected natural rate and does not currently suggest an increased risk following the vaccines. We will continue to monitor these events, including through evaluation of electronic healthcare record data.</p>
<h3 id="thrombo-embolic-events">Thrombo-embolic events</h3>
<p>Following a rigorous scientific review of all the available data, the available evidence does not suggest that blood clots in veins (venous thromboembolism) are caused by COVID-19 Vaccine AstraZeneca. This follows a detailed review of reported cases as well as data from hospital admissions and GP records. This has been confirmed by the Government&rsquo;s independent advisory group, the Commission on Human Medicines, whose expert scientists, and clinicians have also reviewed the available data.</p>
<p>A further, detailed review into UK reports of a very rare and specific type of blood clot in the cerebral veins (sinus vein thrombosis) occurring together with lowered platelets (thrombocytopenia) is ongoing. This has been reported in less than 1 in a million people vaccinated so far in the UK and can also occur naturally &ndash; a causal association with the vaccine has not been established.</p>
<p>The MHRA&rsquo;s advice remains that the benefits of the vaccines against COVID-19 continue to outweigh any risks and that the public should continue to get their vaccine when invited to do so. For more information, see&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/news/uk-regulator-confirms-that-people-should-continue-to-receive-the-covid-19-vaccine-astrazeneca">our statement</a>.</p>
<h3 id="events-with-a-fatal-outcome">Events with a fatal outcome</h3>
<p>Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination. A high proportion of people vaccinated in the vaccination campaign so far are very elderly, many of whom will also have pre-existing medical conditions. Older age and chronic underlying illnesses make it more likely that coincidental adverse events will occur, especially given the millions of people vaccinated. It is therefore important that we carefully review these reports to distinguish possible side effects from illness that would have occurred irrespective of vaccination.</p>
<p>Part of our continuous analysis includes an evaluation of natural death rates over time, to determine if any specific trends or patterns are occurring that might indicate a vaccine safety concern. Based on age-stratified all-cause mortality in England and Wales taken from the Office for National Statistics death registrations, several thousand deaths are expected to have occurred, naturally, within 7 days of the many millions of doses of vaccines administered so far, mostly in the elderly.</p>
<p>The MHRA has received 259 UK reports of suspected ADRs to the Pfizer/BioNTech vaccine in which the patient died shortly after vaccination, 326 reports for the Oxford University/AstraZeneca vaccine and 9 where the brand of vaccine was unspecified. The majority of these reports were in elderly people or people with underlying illness. Usage of the AstraZeneca has increased rapidly and as such, so has reporting of fatal events with a temporal association with vaccination however, this does not indicate a link between vaccination and the fatalities reported. Review of individual reports and patterns of reporting does not suggest the vaccine played a role in the death.</p>
<h2 id="conclusion-1"><span class="number">4.&nbsp;</span>Conclusion</h2>
<p>At the time of this report, over 125,000 people across the UK have died within 28 days of a positive test for coronavirus. Rates of COVID-19 infection and hospitalisation remain&nbsp;<a class="govuk-link" href="https://coronavirus.data.gov.uk/" rel="external">high</a>.</p>
<p>Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. A national immunisation campaign has been underway since early December 2020.</p>
<p>In&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/collections/mhra-guidance-on-coronavirus-covid-19#vaccines-and-vaccine-safety">clinical trials</a>, the Pfizer/BioNTech and Oxford University/AstraZeneca COVID-19 vaccines have demonstrated very high levels of protection against symptomatic infection. We expect data to be available soon on the impact of the vaccination campaign in reducing infections and illness with COVID-19 in the UK.</p>
<p>All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness.</p>
<p>Following widespread use of these vaccines across the UK, the vast majority of suspected adverse reaction reports so far confirm the safety profile seen in clinical trials. Most reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as a &lsquo;flu-like&rsquo; illness, headache, chills, fatigue, nausea, fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these reactions are not associated with more serious illness and likely reflect an expected, normal immune response to the vaccines.</p>
<p>Following very substantial exposure across the UK population, no other new safety concerns have been identified from reports received to date, and for the cases of other medical conditions reported in temporal association with vaccination, the available evidence does not currently suggest that the vaccine caused the event.</p>
<p>The overall safety experience with both vaccines is so far as expected from the clinical trials. The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is a continuously monitored and benefits and possible risks remain under review.</p>
<p>We take every report of a suspected ADR seriously and encourage everyone to report through the Yellow Card scheme.</p>
<h2 id="annex-1-vaccine-analysis-print">Annex 1: Vaccine Analysis Print</h2>
<p>The attached Vaccine Analysis Profile contains a complete listing of all suspected adverse reactions or that have been reported to the MHRA via the Yellow Card scheme for the COVID-19 mRNA Pfizer/BioNTech vaccine. This includes all reports received from healthcare professionals, members of the public, and pharmaceutical companies.</p>
<p>This information does not represent an overview of the potential side effects associated with the vaccines. A list of the recognised adverse effects of COVID-19 vaccines is provided in the information for healthcare professionals and the recipient information here. These can also be found on the&nbsp;<a class="govuk-link" href="https://coronavirus-yellowcard.mhra.gov.uk/" rel="external">Coronavirus Yellow Card reporting site</a>. Conclusions on the safety and risks of the vaccines cannot be made on the data shown in the Print alone.</p>
<p>When viewing the vaccine analysis print you should remember that:</p>
<ul>
<li>Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the medicine may have caused the adverse reaction. The existence of an adverse reaction report in the print does not necessarily mean that the vaccine has caused the suspected reaction.</li>
<li>It may be difficult to tell the difference between something that has occurred naturally and a suspected adverse reaction. Sometimes these events can be part of the condition being treated rather than being caused by the vaccine.</li>
<li>Many factors have to be considered when assessing whether the vaccine has caused a reported adverse reaction. When monitoring the safety of vaccines and medicines, MHRA staff carry out careful analysis of these factors.</li>
</ul>
<p>For a medicine or vaccine to be considered safe, the expected benefits will be greater than the risk of having harmful reactions. It is important to note that most people take medicines and vaccines without having any serious side effects.</p>
<p><a class="govuk-link" href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/964207/COVID-19_mRNA_Pfizer-_BioNTech_Vaccine_Analysis_Print__1_.pdf" rel="external">Vaccine Analysis Profile - Pfizer/BioNTech</a></p>
<p><a class="govuk-link" href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/964208/COVID-19_AstraZeneca_Vaccine_Analysis_Print__2_.pdf" rel="external">Vaccine Analysis Profile - Oxford University/AstraZeneca</a></p>
<p><a class="govuk-link" href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/964209/COVID-19_vaccine_brand_unspecified_analysis_print__1_.pdf" rel="external">Vaccine Analytics Profile - brand unspecified</a></p>
<h2 id="annex-2-glossary">Annex 2 Glossary</h2>
<h3 id="anaphylaxis-or-anaphylactoid-reactions">Anaphylaxis or anaphylactoid reactions</h3>
<p>Anaphylaxis is a severe and potentially life-threatening allergic reaction. These reactions can occur after an exposure to a trigger, such as a certain ingredient in foods or medicines or an insect sting. Anaphylaxis and anaphylactoid reactions can be treated with adrenaline.</p>
<h3 id="bells-palsy-1">Bell&rsquo;s palsy</h3>
<p>Bell&rsquo;s palsy is a condition that causes temporary weakness or paralysis (lack of movement) of the muscles in one side of the face. It is the most common cause of facial paralysis. For most people, the facial paralysis is temporary. Viral infections such as those with herpes viruses have been linked to Bell&rsquo;s palsy.</p>
<h3 id="clinical-practice-research-datalink-cprd">Clinical Practice Research Datalink (CPRD)</h3>
<p><a class="govuk-link" href="https://www.cprd.com/" rel="external">Clinical Practice Research Datalink</a>&nbsp;(CPRD) is a real-world research service to support public health and clinical studies. CPRD is jointly sponsored by the Medicines and Healthcare products Regulatory Agency and the National Institute for Health Research (NIHR), as part of the Department of Health and Social Care. CPRD collects anonymised patient data from a network of GP practices across the UK.</p>
<h3 id="commission-on-human-medicines-chm">Commission on Human Medicines (CHM)</h3>
<p>The&nbsp;<a class="govuk-link" href="https://www.gov.uk/government/organisations/commission-on-human-medicines">Commission on Human Medicines</a>&nbsp;(CHM) advises ministers on the safety, efficacy and quality of medicinal products. For COVID-19 vaccines, the CHM has a COVID-19 Vaccines Safety Surveillance Methodologies Expert Working Group and a COVID-19 Vaccines Benefit Risk Expert Working Group.</p>
<h3 id="epidemiology-studies">Epidemiology studies</h3>
<p>Epidemiological studies include large numbers of people and are designed to compare the risk of a particular event in an exposed population, in this case those who have received a vaccine, to those who have not. They attempt to account for differences in the different groups to help us understand if any difference in risk is caused by the exposure. Epidemiological studies measure the risk of illness or death in an exposed population compared to that risk in an identical, unexposed population.</p>
<h3 id="regulation-174-authorisation">Regulation 174 authorisation</h3>
<p>Temporary authorisation for supply of a medicine or vaccine by the UK Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency. This temporary authorisation grants permission for a medicine (vaccine) to be used for active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus. Authorisation is subject to a number of conditions. These are available for each vaccine on the MHRA website.</p>
<h3 id="suspected-adverse-reactions">Suspected adverse reactions</h3>
<p>Also known as side effects. All medicines or vaccines can cause adverse reactions in some people. Adverse drug reactions reported to the MHRA are looked at and used to assess the balance of risks and benefits of medicines and vaccines.</p>
<h3 id="temporal-association">Temporal Association</h3>
<p>Events occurring following vaccination but may or may not be caused by the vaccine.</p>
<h3 id="yellow-card-scheme">Yellow Card scheme</h3>
<p>The MHRA&rsquo;s scheme for healthcare professionals and members of the public to report suspected adverse reactions for a medicine or vaccine, as well as medical devices and other products. The&nbsp;<a class="govuk-link" href="https://coronavirus-yellowcard.mhra.gov.uk/" rel="external">dedicated Coronavirus Yellow Card reporting site</a> was launched in May 2020 specifically for medicines and medical devices used in COVID-19, as well as COVID-19 vaccines when authorised.</p>
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