Received Dec 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Blood clot; This is a solicited report received from a consumer, Program ID. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), 10 days after the suspect product(s) administration, outcome "unknown", described as "Blood clot". The patient was able to get her COVID-19 shot and 10 days later, she had blood clot. The reporter's assessment of the causal relationship of "blood clot" with the suspect product(s) BNT162b2 omicron (lp.8.1) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The event thrombosis is conservatively assessed as related to the suspect drug BNT162B2 OMICRON (LP.8.1) based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.