Freedom of Information request about COVID-19 vaccine adverse reaction reports (FOI-21-158)
Published 7 May 2021
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8th March 2021
Dear
Our Ref: FOI 21/158
Thank you for your email dated 6th February 2021, where you asked:
“Please can you send me the Yellow Card data as submitted and without editing between delivery of the first Covid-19 vaccination on 8 December 2020 and 5 February 2021.
Specifically, I am requesting the following information for both the Pfizer and AstraZeneca vaccines:
The total number of each type of adverse reaction reported, including deaths, and the age of the individuals affected by each type of reaction”
Yellow Card reports contain patient information and are 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.
In response to your request for information about adverse reaction (ADR) reports to COVID-19 vaccines by age group, 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 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.
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