FOI release
Pfizer batches FA1027 and FF3319
Some or all of the information requested was not provided because we didn't hold it.
Case reference FOI2026/00930
Received 20 August 2026
Published 7 October 2026
Request
I am making a request under the Freedom of Information Act 2000 regarding suspected adverse drug reaction reports submitted to the MHRA Yellow Card Scheme for Pfizer-BioNTech COVID-19 vaccine batches FA1027 and FF3319. For each batch separately, please provide the following information held by the MHRA: 1. The total number of UK Yellow Card reports associated with the batch. 2. The total number of reported reactions/events associated with the following MedDRA preferred terms, or the closest equivalent terms used within the MHRA database: * Aortic dissection * Artery dissection * Aortitis * Periaortitis * Arteritis * Vasculitis * Aortic aneurysm * Iliac artery aneurysm * Iliac artery dissection * Aortic thrombosis * Arterial thrombosis * Thrombosis * Tachycardia * Sinus tachycardia * Palpitations * Exercise intolerance * Dyspnoea on exertion 1. For each of the above reaction terms, where held, please provide: * number of individual Yellow Card reports; * number classified as serious; * number resulting in hospitalisation; * number resulting in death; * patient age and sex in aggregated form where disclosure permits. 1. Please provide the dates, or at least month and year, on which reports involving aortic dissection, artery dissection, aortitis, periaortitis, arteritis or vasculitis were received for either batch. 2. Please state how many doses from batches FA1027 and FF3319 were distributed and/or administered in the United Kingdom, if this information is held. If exact administration figures are not held, please provide the closest available denominator, such as doses supplied or released. 3. Please provide any safety signal assessment, pharmacovigilance review, internal analysis or aggregate assessment specifically relating to either FA1027 or FF3319, insofar as this can be supplied within the appropriate FOI cost limit. I am not requesting individual patient-identifiable information, copies of individual Yellow Card forms or personal medical information. If some of the requested terminology does not correspond precisely with the MedDRA coding used by MHRA, please use the closest applicable Preferred Term and state which terminology was used. If any element of this request would exceed the statutory cost limit, please provide the information that can be supplied within the limit and advise me how the remaining request could be narrowed. Where practical, I would prefer the numerical information in CSV or spreadsheet format, although a table within the response is also acceptable.
Response
See attached
Documents
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