Freedom of Information request on the number of adverse events reported through Yellow Card scheme for the Isle of Man that have been reported for all COVID-19 vaccines (FOI 21/1152)
Published 26 May 2022
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FOI 21/1152
18th November 2021
Dear
Thank you of your email dated 22nd October 2021, where you requested the following:
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Please can you confirm the number of adverse events reported through Yellow Card scheme for the Isle of Man that have been reported for all COVID-19 vaccines? This would be postcodes starting IM1 to IM9.
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If possible, could we have the information split into the reaction reported and also age categories?
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Could you also confirm if any deaths have occurred and if so in what age categories?
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.
You also requested information on the reported reactions and number of reports with a fatal outcome within these reports. 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 contains one report which reported two different brands of vaccines as suspect vaccinations which have therefore been displayed separately.
Table 1: UK spontaneous suspected ADR reports received up to and including 3rd November 2021, from Isle of Man in association with COVID-19 vaccines.
Reported vaccine Number of suspected ADR reports Number of suspected fatal ADR reports
| Reported vaccine | Number of suspected ADR reports | Number of suspected fatal ADR reports | ||
|---|---|---|---|---|
| COVID-19 Pfizer/ BioNTech Vaccine | 251 | 2 | ||
| COVID-19 Vaccine AstraZeneca | 599 | 1 | ||
| COVID-19 Vaccine Moderna | 33 | 0 | ||
| Total | 883 | 3 |
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.
In relation to your question about the breakdown of the reports according to age categories, as we plan to publish this data, we have determined that this request is exempt under Section 22 of the Freedom of Information Act. Section 22 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. We consider that the public interest will be better served by releasing the information when it is in its complete form.
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