Freedom of Information request on the updated figures for adverse reactions for all brands of COVID-19 vaccines to date received from the Isle of Man, and updated Drug Analysis Print attachments for each vaccine (FOI 21/1208)
Published 26 May 2022
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FOI 21/1208
19th November 2021
Dear,
Thank you for your email dated 11th November 2021, where you requested:
• Updated figures for adverse reactions for all brands of COVID-19 vaccines to date received from the Isle of Man, and updated Drug Analysis Print attachments for each vaccine.
Further to your request I can confirm that up to and including 03/11/2021 the MHRA have received 882 UK suspected spontaneous Adverse Drug Reaction (ADR) reports associated with a COVID-19 vaccine where the reporter postcode was registered within the Isle of Man (IM1 to IM9). 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.
Please also find attached Vaccine Analysis Prints (VAPs) for these 882 ADR reports received from the Isle of Man. The VAP contains complete data for all spontaneous suspected adverse drug reactions, or side effects, 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 adverse drug reaction (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 routine 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.
• Additionally, 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