Received Mar 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | OT |
Blood clot in left leg; ASSESSMENT PROGRAM This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. A 76-year-old female patient received BNT162b2 (COMIRNATY), on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 76 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (dose 1), administration date: 25Feb2021, when the patient was 76-year-old, for immunisation, reaction(s): "blood clot in right leg". The following information was reported: THROMBOSIS (medically significant) with onset 17Mar2021, outcome "unknown", described as "Blood clot in left leg". The event "blood clot in left leg" required emergency room visit. Therapeutic measures were taken as a result of thrombosis and included treatment with apixaban (ELIQUIS) 5 mg twice daily. The reporter's assessment of the causal relationship of "blood clot in left leg" with the suspect product(s) BNT162b2 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. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on known disease pathophysiology, the event thrombosis is assessed as not related to BNT162B2, and more likely due to strong underlying predisposition to clotting with contributory factors such as advanced age and a recent prior thrombosis in the opposite leg.