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Medicines & Healthcare products
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Research and analysis
Coronavirus vaccine - weekly summary of Yellow
Card reporting
Updated 10 June 2021
Contents
Summary
1. Introduction
2. Yellow Card reports
3. Analysis of data
4. Conclusion
Annex 1: Vaccine Analysis Print
Annex 2 Glossary
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vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting
This report covers the period 9 December 2020 to 2 June 2021.
Summary
At the time of this report, over 127,820 people across the UK have died within 28 days of a
positive test for coronavirus (COVID-19).
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.
Three COVID-19 vaccines, Pfizer/BioNTech, COVID-19 Vaccine AstraZeneca and COVID-19
Vaccine Moderna, are currently being used in the UK. All 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 (https://www.gov.uk
/government/collections/mhra-guidance-on-coronavirus-covid-19#vaccines-and-vaccine-safety), the
vaccines showed very high levels of protection against symptomatic infections with COVID-19.
Data are now available (https://www.gov.uk/government/publications/phe-monitoring-of-the-effectiveness-
of-covid-19-vaccination) 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 (https://www.gov.uk/government/publications
/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/information-for-healthcare-professionals-on-
pfizerbiontech-covid-19-vaccine) 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 COVID-19 Vaccine AstraZeneca was evaluated in clinical trials involving more than 23,000
participants. The most frequently reported adverse reactions (https://www.gov.uk/government
/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/information-for-healthcare-professionals-
on-covid-19-vaccine-astrazeneca) 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 COVID-19 Vaccine Moderna was evaluated in clinical trials involving more than 30,000
participants. The most frequent adverse reactions in these trials were pain at the injection site,
fatigue, headache, myalgia (muscle pains), arthralgia (joint pains), chills, nausea/vomiting, axillary
swelling/tenderness (swelling/tenderness of glands in the armpit), fever, injection site swelling and
redness; 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 65 years) than in younger people.
The MHRA’s role is to continually monitor safety during widespread use of a vaccine. We have in
place a proactive strategy to do this (https://www.gov.uk/government/publications/report-of-the-
commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance). 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 (https://yellowcard.mhra.gov.uk/). 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 2 June 2021. At this date, an
estimated 14.7 million first doses of the Pfizer/BioNTech vaccine and 24.5 million first doses of the
COVID-19 Vaccine AstraZeneca had been administered, and around 10.7 million and 15.7 million
second doses of the Pfizer/BioNTech vaccine and COVID-19 Vaccine AstraZeneca respectively.
An approximate 0.46 million first doses of the COVID-19 Vaccine Moderna have also now been
administered.
As of 2 June 2021, for the UK, 67,998 Yellow Cards have been reported for the Pfizer/BioNTech
vaccine, 195,641 have been reported for the COVID-19 Vaccine AstraZeneca, 3,278 for the
COVID-19 Vaccine Moderna and 754 have been reported where the brand of the vaccine was not
specified.
For the Pfizer/BioNTech vaccine, COVID-19 Vaccine AstraZeneca vaccines and COVID-19
Vaccine Moderna the overall reporting rate is around 3 to 7 Yellow Cards per 1,000 doses
administered.
In the week since the previous summary for 26 May 2021 we have received a further 3,548 Yellow
Cards for the Pfizer/BioNTech vaccine, 7,052 for the COVID-19 Vaccine AstraZeneca, 809 for the
COVID-19 Vaccine Moderna and 38 where the brand was not specified.
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 all COVID-19 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 (https://www.gov.uk/drug-safety-
update/covid-19-vaccines-pfizer-slash-biontech-and-covid-19-vaccine-astrazeneca-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
