Freedom of Information request on adverse reactions reported following the COVID-19 vaccinations in North Central London (FOI 22/420))
Published 31 May 2022
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FOI 22/420
25th February 2022
Dear
Thank you for your FOI request dated 2nd February 2022, where you requested the following information:
“COVID vaccinations adverse drug reactions for North Central London… We cover the boroughs of Islington, Camden, Haringey, Barnet and Enfield”
When considering the spontaneous Adverse Drug Reaction (ADR) data, it is important to be aware of the following points:
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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 vaccines are given in the UK alone, and when any vaccine is administered to very large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms or events occur after use of a vaccine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the vaccine. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
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It is also important to note that 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. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.
As these data do not necessarily refer to proven side effects, you should refer to the product information which can be found here: https://www.gov.uk/guidance/find-product-information-about-medicines for details on the possible side effects of the vaccine.
All of the data provided below relates to UK spontaneous, suspected ADR reports concerning COVID-19 vaccines received directly by the MHRA (not via pharmaceutical companies). Data provided
includes COVID-19 vaccine ADR reports from the geographical area covered by the NHS Islington, Camden, Haringey, Barnet and Enfield Clinical Commissioning Groups up to and including 22nd February 2022. Please note that the accuracy of the data relies on the postcode being provided by the reporter. Where reporters have only provided an email address and not a postal address these reports will not be included in the numbers provided below.
Table 1: Direct UK spontaneous suspected ADR reports for COVID-19 vaccines received from NHS Islington, Camden, Haringey, Barnet and Enfield Clinical Commissioning Groups up to and including 22nd February 2022.
| COVID-19 Vaccine | Number of Yellow Card Reports | Total Number of ADRs Reported | Number of Yellow Card Reports with a fatal outcome |
|---|---|---|---|
| AstraZeneca | 4854 | 16937 | 18 |
| Moderna | 1022 | 3348 | 1 |
| Pfizer/ BioNTech | 3203 | 3109 | 9 |
| Brand unspecified | 19 | 64 | 1 |
A full list of reported adverse reactions and associated fatal outcomes is provided in the attached Vaccine Analysis Prints (VAPs). Please refer to the enclosed information sheet for guidelines on how to interpret the VAPs.
The MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes including the Yellow Card scheme. As part of our signal detection processes all adverse reaction reports received by the Yellow Card scheme are individually assessed and cumulative information reviewed at regular intervals. Any emerging evidence relating to possible risks associated with vaccines and medicines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.
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