FOI release

Freedom of Information request about adverse drug reactions (ADR) to Covid-19 vaccines (FOI 21/194)

Published 7 May 2021

Thank you for your email dated 21stFebruary2021, where you requested the following information for the COVID-19vaccines:

“rate of vaccine injury reported so far under the yellow card scheme for COVID 19 vaccines.Information should include the number of people, gender, ages, the reported injury, and the type of vaccine.”

We can confirm that the MHRA does hold this data.

We intend 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 iDAPswill enable users to view the data by categories of their choice such as age, sex and seriousness of reports.

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 inseeing this data and accept it should not be withheld

We will send you a link to the iDAPs once they are published.The current published data can be accessed here: 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 foran 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 TeamVigilance and Risk Management of Medicines DivisionThe MHRA information supplied in response to your request is subject to Crown copyright. The FOIA only entitles you to access to MHRA information. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information

If you have a query about this email, please contact us. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write

to the Communications Directorate, Medicines and Healthcare products Regulatory Agency, (via this email address). After that, if you remain dissatisfied, you may ask the Information Commissioner at:

The Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF