FOI release

Freedom of Information request on the reported adverse reactions to the COVID-19 vaccines via the Yellow Card Scheme (FOI 21/1053)

Published 27 April 2022

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-4-october-2021/freedom-of-information-request-on-the-reported-adverse-reactions-to-the-covid-19-vaccines-via-the-yellow-card-scheme-foi-211053

8th October 2021

FOI 21/1053

Dear

Thank you for your email dated 12th September 2021, where you asked for information on the following:

‘Could you please provide me with a drug analysis print report for all vaccines (COVID-19 vaccines) that have been reported via the Yellow Card scheme for Gibraltar (Overseas Territory) and GIBRALTAR , GX11 1AA’

I can confirm that the Medicines and Healthcare products Regulatory Agency (MHRA) has received 28 spontaneous suspected Adverse Drug Reaction (ADR) reports associated with the COVID-19 vaccines from the postcode GX11 1AA, up to the 29th September. This includes 26 ADR reports with the COVID-19 Pfizer/BioNTech vaccine, of which we have provided a Vaccine Analysis Print (VAP) for, and two reports for the COVID-19 AstraZeneca vaccine. The two reports for the COVID-19 AstraZeneca vaccine included one report of paraesthesia and one report of paraesthesia oral, which are in line with those reactions seen within clinical trial data and are listed within the product information.

Please note, the information supplied in this response relies on the postcode being provided as GX11 1AA by the reporter on the original Yellow Card. Furthermore, if the postcode is incorrectly provided or incomplete, or the reporter has provided an email address in place of a postal address, the Yellow Card will not be included in this data. As the data has been extracted using available postal addresses only, it may not reflect the true number of ADR reports following COVID-19 vaccination reported from Gibraltar. Please also find attached a guidance sheet which provides you with information on how to interpret the print.

When considering the attached spontaneous data, it is important to be aware of the following points:

  • A reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. Each year, millions of doses of vaccinations are given in the UK alone, and when any vaccine is administered to large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms occur after use of a vaccine or medicine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by it. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

  • It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction or compare the safety profile of different vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular medicine, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.

The MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes including the Yellow Card Scheme. As part of our signal detection processes all adverse reaction reports received by the Yellow Card Scheme are assessed and cumulative information reviewed at regular intervals. If appropriate, regulatory action would be taken if any serious risks were confirmed.

As these data do not necessarily refer to proven side effects, you should refer to the product information which can be found here: https://coronavirus-yellowcard.mhra.gov.uk/productinformation for details on the recognised possible side effects of each vaccine.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division

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