FOI release

Freedom of Information request (FOI 22/889)

Published 17 January 2024

FOI 22/889

1st September 2022

Dear

Thank you for your FOI request dated 11 August 2022 where you requested the individual ages of the 6 patients under the age of 18 referenced within Table 11 of the Coronavirus vaccine - summary of Yellow Card reporting published 4 August 2022.

Unfortunately, we are unable to provide the information requested above as your request is exempt from disclosure under Section 40 (personal information) and Section 41 (information provided in confidence) of the Freedom of Information Act. Providing you with the specific ages of the patients in Table 11 could lead to patient identification.

Members of the public and healthcare professionals voluntarily submit reports of suspected side effects to the MHRA through the Yellow Card Scheme. As outlined in our Privacy Policy, the MHRA will not share the identity of anyone submitting a Yellow Card report with any person outside the MHRA without their explicit consent, unless we are required or permitted to do so by law. The Policy also states that we may receive requests for Yellow Card report data under the Freedom of Information Act. While we are legally obliged to provide some of the requested information, we only provide high-level summary information with all person-identifiable data excluded.

The MHRA has been working proactively to encourage members of the public or health professionals across the UK to immediately alert us to any concerns they have without a formal diagnosis using the Yellow Card scheme. The information and data provided to us by these third parties are shared in confidence and, as above, are personal data. Sharing the information and data received with yourself would not reflect the commitments in MHRA’s confidentiality agreements. As this is personal data in relation to an individuals’ health, this would be of detriment to them and may damage the engagement with the scheme.

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 Safety and Surveillance Medicines and Healthcare products Regulatory Agency