FOI release

Subject: FOIA Request – Batch FH4751 – Underlying Clinical Causes of Dyspnoea Reports

Case reference FOI2026/00205

Received 25 February 2026

Published 28 October 2026

Request

I write under the Freedom of Information Act 2000 in relation to the Pfizer/BioNTech COVID-19 vaccine batch FH4751. The published case series print indicates 60 reports coded as “Dyspnoea” (shortness of breath) for this batch. I am seeking a breakdown of the underlying clinical causes or diagnoses associated with those dyspnoea reports. For the reports in which dyspnoea was recorded, please provide: 1. A breakdown of the stated or subsequently identified clinical diagnoses or medical conditions associated with the breathlessness (for example pulmonary embolism, myocarditis, cardiac arrhythmia, anaphylaxis, pneumonia, interstitial lung disease, hypersensitivity pneumonitis, heart failure, anxiety-related hyperventilation, or any other identified cause). 2. Where no specific diagnosis was identified, please confirm how many dyspnoea reports were recorded without an underlying cause being specified. 3. Please confirm whether the MHRA reviewed the dyspnoea reports for batch FH4751 to determine whether a common clinical mechanism or safety signal was present, and if so, provide the conclusion of that review. I am not requesting identifiable personal data, but a substantive breakdown of the underlying clinical causes recorded in association with the dyspnoea reports.

Response

See attached

Documents

• FOI2026_00205 (redacted).pdf (1.1 MB)

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