Freedom of Information request on information for both the total number and the fatal number broken down into standard age ranges for Cardiac Failure and Coronary Artery Thrombosis as well as the yellow card entries (FOI-21-771)
Published 27 April 2022
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3rd August 2021 FOI 21/771
Dear
Thank you for your Freedom of Information (FOI) request dated 3rd July 2021 where you requested the following: “I would like the information for both the total number and the fatal number broken down into standard age ranges.
Cardiac Failure – Total Report 60nr – 9nr fatal Coronary Artery Thrombosis Total cases 12nr Fatal 3nr Cardiac Arrest total cases 146nr Fatal 32nr Myocardial Infarction total cases 323nr fatal 43nr I would also like copied of all of these yellow card entries.”
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. Regarding your request for copies of yellow card reports, 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.
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