Freedom of Information request on suspected adverse drug reactions after COVID-19 vaccines
Published 28 May 2021
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-26-april-2021/freedom-of-information-request-on-suspected-adverse-drug-reactions-after-covid-19-vaccines
27th April 2021 FOI 21/308 Dear
Thank you for your email dated 26th March 2021, where you asked for the following information:
a) number of deaths (since COVID vaccines began in U.K. on 8 December) following 21 days or more of receiving a first dose of vaccine where the patient died with a positive COVID diagnosis; b) number of deaths within 28 days of a first or second dose of COVID vaccine where the patient died without a positive COVID diagnosis; c) details of length of time between vaccine and death for a) and b) above and whether death occurred after the first or second vaccine; and d) which vaccine (Pfizer/AstraZeneca etc.) was received by the deceased.
Suspected adverse drug reactions can be reported via the Yellow Card scheme at any time after the side effect has occurred. Additionally, the time frame from when the patient received the vaccine to experiencing a suspected side effect is not always provided by the reporter. We review all reports of death regardless of the time to onset from receiving a medicine or vaccine. Our routine ADR summary publication provides information on all reports received associated with COVID-19 vaccines including fatalities. https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions
We follow-up all fatalities where permission has been provided to do so for further information including post-mortem details if available. As with any serious suspected ADR, reports with a fatal outcome are fully evaluated by the MHRA, to consider whether the vaccine (or medicine) may have caused the event, or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness.
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