Freedom of Information request on updated set of adverse reaction figures for the Isle of Man, as previously provided for FOI 21/401 (FOI 21/1276)
Published 31 May 2022
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Dear
Thank you of your email dated 1st December 2021, where you requested the following:
• Updated set of adverse reaction figures for the Isle of Man, as previously provided for FOI 21/401.
Further to your request I can confirm that up to and including 12th December 2021 the MHRA have received 932 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 see Table 1 below for a breakdown of the number of reports received from Isle of Man for each COVID-19 vaccine. Please note that the total number of ADR reports displayed in Table 1 does not equate to the total number of ADR reports received for the Isle of Man referenced above. This is because Table 1 includes one report containing two different brands of suspected vaccines which have therefore been displayed separately.
Table 1: UK spontaneous suspected ADR reports received up to and including 12th December 2021, from Isle of Man in association with COVID-19 vaccines.
| Product | Number of Yellow Cards |
|---|---|
| Oestrodose | 160 |
| Oestrogel | 570 |
| Estrogel | 51 |
Please find attached Vaccine Analysis Prints (VAPs) for each vaccine brand. The VAP contains complete data for all spontaneous suspected ADRs, 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 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