FOI release

Freedom of Information request on adverse drug reactions received for COVID-19 vaccinations (FOI 22/490)

Published 1 June 2022

FOI 22/490 - FW: Enquiry on ICSR dataset for academic research

18th March 2022

Dear

Thank you for your FOI request dated 18th February.

We can confirm that we hold this data however patient information is exempt from release under Section 40 of the FOI Act which protects personal data, the disclosure of which would breach one or more of the data protection principles therefore we cannot provide individual case safety reports.

For COVID-19 vaccinations we are proactively publishing details of adverse drug reactions received, including MHRA assessment of the data to provide context. Please note this data is updated weekly.

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

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.

Kind regards,

FOI Team

Vigilance and Risk Management of Medicines Division

Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU