FOI release

Freedom of Information request on the adverse reactions reported following the COVID-19 vaccinations in the Isle of Man (FOI/040 & FOI 22/508)

Published 27 March 2023

FOI 22/040 FOI 22/508

9th May 2022

Dear

Thank you for your emails dated 10 January and 1 March 2022, where you requested the following Yellow Card data for the Isle of Man on COVID-19 vaccines:

A. provide updated figures for adverse events for ALL brands of COVID-19 vaccines to date, and updated DAP attachments for each vaccine to the current date.

If this information is available:

B. provide the age of those who reported the adverse events

C. provide information on the number of vaccinations (1st, 2nd or booster, etc) of the people reporting, and the time after that the adverse event occurred.

D. The batch number of the COVID-19 vaccine that caused the adverse event

Further to your request I can confirm that up to and including the 20th April 2022 the MHRA have received 1,016 direct UK suspected spontaneous Adverse Drug Reaction (ADR) reports associated with a COVID-19 vaccines where the reporter postcode was registered within the Isle of Man (IM1 to IM9). Please be aware that the data included in this response has been extracted based on reporter postal code; therefore, the accuracy of this data relies on the postcode being correctly provided in the original Yellow Card. It is also important to note that the provision of a postal address is not a requirement to submit a report and therefore, this information is not always provided. Table 1 below provides the number of reports that have been received for each of the COVID-19 vaccines. It is important to note that the number of reports in the table will not add up to the total (995 reports) as one report may contain more than one brand of COVID-19 vaccine.

Table 1: Total number of suspected ADR reports from Isle of Man up to and including 20th April 2022.

Brand of COVID-19 vaccine	Total number of ADR reports
COVID-19 Vaccine AstraZeneca	625
COVID-19 Vaccine Moderna	86
COVID-19 Pfizer/ BioNTech vaccine	307
COVID-19 vaccine - brand unspecified	0

In addition to the table provided, please find enclosed Vaccine Analysis Prints (VAPs), which list all reported spontaneous suspected ADRs associated with the COVID-19 vaccines up to and including 20th April 2022 received from the Isle of Man. Three VAPs are provided, one each for the COVID-19 Pfizer/BioNTech vaccine, COVID-19 Vaccine AstraZeneca and COVID-19 Vaccine Moderna. I can confirm the MHRA have received no cases from the Isle of Man reporting a COVID-19 vaccine where the brand was not specified. Please refer to the attached information sheet for guidelines on how to interpret the prints.

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.

As this data does not necessarily refer to proven side effects, you should refer to the product information (Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL)) for details on the possible side effects of each COVID-19 vaccine, which can be found here.

We consider that providing the data requested in points B, C and D above alongside the adverse event experienced by a patient in a particular geographical location is covered under Section 40 and 41 of the Freedom of Information Act and is therefore exempt from disclosure. Section 40 (personal information) protects personal data, the disclosure of which would breach one or more of the data protection principles. The Agency is satisfied that disclosure here would breach the first data protection principle, in particular the requirement of fairness on the basis that disclosure would not be reasonably expected by the people mentioned in the information. Section 41 relates to information provided to us in confidence, with the expectation that it will not be released. Information will be covered by Section 41 if it was obtained by the authority from any other person; its disclosure would constitute a breach of confidence; a person or organisation could bring a court action for that breach of confidence; and that court action would be likely to succeed.

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 this response’s date and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division