FOI release

Freedom of Information request on the adverse reactions reported following the COVID-19 vaccinations (FOI/735)

Published 21 December 2023

FOI 22/735

4th July 2022

Dear

Thank you for your Freedom of Information request dated 2 June 2022 in which you requested the following:

Can you provide a dataset summarising all suspected adverse reactions to COVID-19 vaccines reported to the MHRA since December 2020. This summary dataset should be in the form of a count by (i) vaccine type, (ii) patient sex, (iii) patient 15-year age band (ie, 0-14, 15-29, etc), (iv) suspected adverse reaction (described using the MedDRA ‘preferred term’), and (v) reaction seriousness (ie, fatal, serious excluding fatal, and non-serious).

Please note that no so-called ‘special category data’ is being requested, and, further, what is being requested is data which is in more summarised form than that published by the MHRA in interactive Drug Analysis Profiles (iDAPs) for other drugs. The request is therefore consistent with the MHRA’s Yellow Card Privacy Policy, which states that only “high-level summary information with all person-identifiable data excluded” will be provided in response to requests under the Freedom of Information Act.

Your request is exempt from disclosure under Section 40 (personal information) and Section 41 (information provided in confidence) of the Freedom of Information Act. As you will be aware from previous correspondence and our response to the ICO (Ref: IC-117930-T6R1), we are already planning to publish COVID-19 vaccine data in 10 years age bands. Providing you with the 15-year age band data could lead to patient identification once the 10-year age band data is published as the two data sources could be collated together to interrogate within a 5-year age bracket.

Use of Section 40 (personal information)

Our rationale for using Section 40, which is an absolute exemption, is as follows. As part of our proactive vigilance surrounding the COVID-19 vaccines, the MHRA collects reports of suspected side effects via the Yellow Card scheme. The Yellow Card scheme underpins medicines and vaccines safety monitoring in the UK. Through this scheme, members of the public and healthcare professionals voluntarily submit reports of suspected side effects to the MHRA. The key strength of the Yellow Card scheme is that it allows any member of the public or health professional across the UK to immediately alert us to any concerns they have without a formal diagnosis. As such, Yellow Card reports are constantly reviewed and may contribute to the identification of a potential safety signal.

The Agency first considered whether the information requested was personal data i.e. if the person is identifiable from the data, either by itself or with other data. Our lawful basis for processing personal data is General Data Protection Regulation (GDPR) Article 6(1)(e), which allows us to process personal data when this is necessary to perform our public tasks as a regulator.

Yellow Card reports require the collection of some information about the individual affected. If a patient is submitting a report about themself, the information will relate to them and include some special category personal data, such as information about their health. The lawful bases we rely on to process special category personal data are Article 9(2)(i) of the GDPR and Schedule 1 part 1(3) of the DPA, both of which enable us to process such information when it is necessary for reasons of the public interest in the area of public health.

Where we share Yellow Card data for scientific or public health research purposes, we rely on GDPR Article 9(2)(j) as our lawful basis for processing special category personal data and Schedule 1 part 1(4) of the DPA. These bases permit us to process personal data for these purposes where it is in the public interest, subject to appropriate safeguards to protect the reporter/patient’s rights and freedoms.

Use of Section 41 (information provided in confidence):

Regarding Section 41, as outlined in our Privacy Policy Privacy Policy - Making medicines and medical devices safer (mhra.gov.uk), 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. As explained above, providing you with the 15-year age band data could lead to patient identification due to 5-year groupings once the 10-year age band data is published.

Please be aware if you continue to submit similar data requests this may be considered as an inappropriate use of the Freedom of Information Act. The Freedom of Information Act places a general duty on public authorities to provide access to official information. However, the Act also provides an exemption to that duty for requests that are determined to be vexatious. Such requests can then be refused under Section 14 (1) of the Freedom of Information Act. Please note that under Section 17(6) of the Freedom of Information Act, should this criteria be met, we may not respond to any further requests on the same or very similar topics.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out. Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely,

MHRA Customer Service Centre