Freedom of Information request (FOI 22/1090)
Published 17 January 2024
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1st December 2022
FOI 22/1090
Dear ,
Thank you for your Freedom of Information (FOI) request dated 4th November 2022 where you requested an anonymised version of a database of adverse reactions to COVID-19 vaccines reported through the Yellow Card reporting system.
You refer to a previous FOI response (21/942) in which the MHRA provided the information that de-identified information from Yellow Cards is routinely provided to organisations. You also refer to FOI 21/640 in which the MHRA stated the intent to publish all suspected reactions reported in association with COVID-19 in the format of interactive Drug Analysis Profiles (iDAP) and stated the Section 22 qualified exception.
Firstly, I would like to acknowledge that as stated in FOI 21/942 the MHRA does send de-identified Yellow Card reports to the World Health Organisation (WHO) and Marketing Authorisation Holders (MAHs), however, these are sent individually through systems and not in a database format. Therefore, the MHRA does not have an anonymised version of the data of reported adverse reactions to COVID-19 vaccines in a database format which could be shared.
The MHRA still intends to publish all suspected reactions reported in association with available COVID-19 vaccines in the interactive format of interactive Drug Analysis Profiles (iDAPS). 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.
We recognise there is a strong interest in seeing this data and anticipate that it will be available to view at the end of this year. As we plan to publish the data, we consider 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 the interest in seeing this data and accept it should not be withheld however wish to publish this information alongside appropriate context and assessment.
I hope this information is useful and would like to thank you for your support of the scheme. Please do not hesitate to contact me if I can be of any further assistance.
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,
Patient Safety Monitoring