Freedom of Information request (FOI 22/1016)
Published 17 January 2024
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1st November 2022
FOI 22/1016
Dear
Thank you for your Freedom of Information (FOI) request dated 4 October 2022 where you requested details on reports of adverse drug reactions (ADRs) to the COVID-19 vaccines.
We have a Coronavirus vaccine - summary of Yellow Card reporting which includes information relevant for all points of your request. This report is published monthly and is updated with the most up to date information on COVID-19 vaccines.
All adverse drug reaction reports are added to our database and are assessed together with additional sources of evidence, by a team of safety experts. Additionally, 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. For further information please view our proactive strategy for surveillance of COVID-19 vaccines.
Up to and including 28 September 2022, the MHRA received and analysed 173,381 UK Yellow Cards reports for the monovalent or bivalent COVID-19 Vaccine Pfizer/BioNTech, 246,393 reports for COVID-19 Vaccine AstraZeneca, 42,436 reports for the monovalent and bivalent COVID-19 Vaccine Moderna and 14 reports for the COVID-19 Vaccine Novavax. Additionally, up to and including 28 September 2022, the MHRA received 1,848 Yellow Card reports where the brand of vaccine was not specified by the reporter.
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. Further details on the number of reports and the reported suspected side effects can be found within the vaccine analysis prints (VAPs) that accompany the published report. However, please note that the reactions listed in the prints should not be used as a list of side effects to the vaccines. For a list of known adverse reactions to the COVID-19 vaccines please view the below links to product information.
COVID-19 Vaccine Pfizer/BioNTech
COVID-19 Vaccine Novavax (Nuvaxovid)
A number of detailed assessments of safety topics have been undertaken and we have updated our advice on these topics accordingly. Further comments on use in specific populations and details on the specific safety topics can be found within the Section titled “Analysis of data”. Overall, our advice remains that the benefits of the vaccines outweigh the risks in the majority of people.
Vaccination is the most effective way to reduce deaths and severe illness from COVID-19, however it is important to note that all vaccines and medicines have some side effects. Unfortunately, it is impossible to accurately predict how different individuals will react to a vaccine. Whilst vaccines can be safe and effective in thousands of patients, other individuals seem to be particularly susceptible to side effects. When considering the safety of these vaccines, side effects need to be continuously balanced against the expected benefits in preventing illness. Data are now available on the impact of the vaccination campaign in reducing infections and illness in the UK.
Yours sincerely,
FOI Team,
Safety and Surveillance