Freedom of Information request asking for a list of list of suspected adverse reactions to COVID-19 vaccines received by the MHRA since December 2020 (FOI 21-351)
Published 28 June 2021
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5th May 2021 FOI 21/351
Thank you for your email dated 3rd April 2021, where you requested the following information for the COVID-19 vaccines:
“Please can you provide the list of suspected adverse reactions to COVID-19 vaccines received by the MHRA since December 2020 broken down by the following attributes: i) Vaccine type ii) Patient age (or age band of a maximum of 5 years) iii) Patient sex iv) Patient ethnicity”
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 iDAPs will 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 in seeing 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
Yellow Card data is releasable to members of the public provided that patient and reporter confidentiality is maintained. Under the Freedom of Information Act (FOIA) 2000 data is releasable as category 1b, patient ethnicity does not fall within this category. Additionally, it is important to note, that whilst we request patient ethnicity data, this is not a mandatory field and therefore does not need to be provided in order to report to the MHRA.
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