Freedom of information request on Adverse event reactions to the Pfizer vaccine in Gibraltar since roll-out (FOI 22/492)
Published 1 June 2022
FOI 22/492
14th March 2022
Dear
Thank you of your follow up email dated 20th February 2022 related to FOI 21/1304, where you requested the following:
- • • Adverse event reactions to the Pfizer vaccine in Gibraltar since roll-out.
Further to your request I can confirm that up to and including 23rd February 2022 the MHRA have received 33 UK suspected spontaneous Adverse Drug Reaction (ADR) reports associated with COVID-19 Pfizer/BioNTech Vaccine where the reporter postcode was registered within Gibraltar (GX). Please note that if the postcode is incorrectly provided or if the reporter has only provided their email address that report will not be included in this output.
The attached Vaccine Analysis Print (VAP) contains complete data for all spontaneous suspected ADRs, as well as those which are associated with a fatal outcome. Please refer to the attached information sheet for guidelines on how to interpret the VAP.
When considering the attached spontaneous ADR 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. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
- • • 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.
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
The MHRA information supplied in response to your request is subject to Crown copyright. The FOIA only entitles you to access to MHRA information.
For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information
If you have a query about this email, please contact us. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 4-T, Medicines and Healthcare products Regulatory Agency, (via this email address). After that, if you remain dissatisfied, you may ask the Information Commissioner at:
The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Copyright notice
The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use o