Freedom of Information request on adverse reactions following COVID-19 vaccination (FOI 21/640)
Published 29 December 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-5-july-2021/freedom-of-information-request-on-adverse-reactions-following-covid-19-vaccination-foi-21640
6th July 2021
FOI 21/640
Dear
Thank you for your email dated 8th June 2021, where you requested the following:
“Please provide an anonymised version of the database of adverse reactions to the various Covid vaccines reported through the yellow card reporting system. Please include ALL data collected for each report, such as the age of the individual, sex of the individual, the identity of the vaccine, whether the reaction is to the first or second vaccination, and how long after the vaccination the reaction occurred, etc.” Please share the data in an easily accessible format, appropriate to the size of the file, and using commonly available spreadsheet software.”
The MHRA intends to publish all suspected reactions reported in association with available COVID-19 vaccines in an interactive format as interactive Drug Analysis Profiles (iDAPs), along with our ADR summary that is published each week. The use of iDAPs will enable users to view the data by categories of their choice such as age, sex and seriousness of reports. Users will also be able to download the data tables in CSV format.
As we plan to publish the data, we consider that your request is covered by Section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for is therefore exempt from disclosure.
Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it. We recognise there is strong interest in seeing this data and accept it should not be withheld however wish to publish this information alongside appropriate context and assessment.
We will send you a link to the iDAPs once they are published.
I hope the information provided and explanation regarding the exemption is helpful. If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.
Yours sincerely,
FOI Team
Vigilance and Risk Management of Medicines Division