Freedom of Information request on the weekly summary of yellow card reports and death fatalities relating to COVID-19 (FOI 21/966)
Published 25 February 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-20-september-2021/freedom-of-information-request-on-the-weekly-summary-of-yellow-card-reports-and-death-fatalities-relating-to-covid-19-foi-21966
20th September 2021
FOI 21/966
Dear
Thank you for your email dated the 20th August, where you asked for information on the following under the Freedom of Information (FOI) act:
Expressed as a number, how many deaths have been removed from the Coronavirus vaccine - weekly summary of Yellow Card reports?
All Yellow Card reports received for COVID-19 vaccines received by the MHRA, including those relating to fatalities, are included in the weekly publication.
Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination. A high proportion of people vaccinated early in the vaccination campaign were very elderly, and/or had pre-existing medical conditions. Older age and chronic underlying illnesses make it more likely that coincidental adverse events will occur, especially given the millions of people vaccinated. As with any serious suspected Adverse Drug Reaction (ADR), reports with a fatal outcome are fully evaluated by the MHRA to distinguish possible side effects from illness that would have occurred irrespective of vaccination. Usage of the vaccines has increased over the course of the campaigns and as such, so has reporting of fatal events with a temporal association with vaccination however, this does not indicate a link between vaccination and the fatalities reported. Review of individual reports and patterns of reporting does not suggest the vaccines played a role in these deaths. To ensure the comprehensive assessment of fatal reports, we follow-up all fatalities where permission has been provided to do so for further information.
Please note that the database used to capture information from Yellow Cards is dynamic and therefore numbers are subject to change over time. Due to high reporting volumes the MHRA sometimes receives multiple reports of the same case from different reporters (for example a family member and a healthcare professional both separately reporting the same event concerning the same individual). When these cases are picked up by us through our regular monitoring processes, we have a responsibility to merge these cases into one. There are also instances where assessors reclassify cases to ensure the case is an accurate representation of what has been reported to the MHRA and update cases as new information is received. These instances can account for fluctuation of numbers in the overall Yellow Card data.
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