Freedom of Information request on a breakdown of adverse reactions for all COVID-19 vaccines in Scotland since the first vaccine was administered (FOI 21/1197)
Published 26 May 2022
© Crown copyright 2022
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-22-november-2021/freedom-of-information-request-on-a-breakdown-of-adverse-reactions-for-all-covid-19-vaccines-in-scotland-since-the-first-vaccine-was-administered-foi
FOI 21/1197
26th November 2021
Dear,
Thank you for your email dated 9th November 2021, where you requested the following:
• A breakdown of adverse reactions for all COVID-19 vaccines in Scotland since the first
vaccine was administered.
Further to your request, I can confirm that up to and including 10/11/2021 the MHRA have received 28,906 UK suspected spontaneous Adverse Drug Reaction (ADR) reports associated with a COVID-19 vaccine where the reporter postcode was registered within Scotland. 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 Scotland 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 Scotland referenced above. This is because Table 1 contains reports 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 10th November 2021, from Scotland in association with COVID-19 vaccines.
| Reported vaccine | Number of suspected ADR reports |
|---|---|
| COVID-19 Pfizer/BioNTech Vaccine | 10144 |
| COVID-19 Vaccine AstraZeneca | 16890 |
| COVID-19 Vaccine Moderna | 1891 |
Please also find attached Vaccine Analysis Prints (VAPs) for these 28,906 ADR reports received from the Scotland. 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. Please note that the VAP for COVID-19 Vaccine AstraZeneca is provided across two time periods, up to and including 30/04/2021 and then
from 01/05/2021–10/11/2021. This is due to limitations in extracting information on the volume of reports required from our current database.
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 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