Freedom of Information request on COVID-19 vaccines ADRs
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-covid-19-vaccines-adrs
30th April 2021 FOI 21/319 Dear
Thank you for your email dated 31st March 2021, where you asked: “Please provide details of adverse reactions reported for all vaccinations in the United Kingdom”
I can confirm that the MHRA collects reports of suspected adverse reactions to medicines and vaccines via the Yellow Card Scheme. Section 12 of the FOI Act specifies that a public authority may refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information. We consider that extracting the adverse reactions data that you have requested will take longer than 24 working hours to complete.
We would be able to provide you with Drug Analysis Prints (DAPs) which include the number of reports of all suspected adverse reactions to a particular medicine or vaccine if you were to narrow your request by, for example, limiting your request to specific vaccines on the schedule.
Additionally, adverse reaction data for COVID-19 vaccines has been published by the MHRA and is available to view at the following link to our webpage: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions
As your request has been refused under Section 12 of the FOI Act, we cannot answer any part of it however we will be happy to provide a response to any refined request you send in the future.
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