Received Mar 17, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
blood clot in right leg; LIVE TELEPHONIC VACCINE 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 24Feb2021 as dose 1, 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. The following information was reported: THROMBOSIS (medically significant) with onset 24Feb2021, outcome "unknown", described as "blood clot in right leg". The event "blood clot in right leg" required emergency room visit. Therapeutic measures were taken as a result of thrombosis. Clinical course: Patient reports developing blood clot in right leg after her first covid vaccine on 24Feb2021. She has since been treated with Eliquis 5mg twice daily for blood clot prevention. The reporter's assessment of the causal relationship of "blood clot in right 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 the known product safety profile, available information and elderly age of the patient, a causal association between the event thrombosis and the suspect product BNT162b2 (COMIRNATY), cannot be made, hence assessed as unrelated to the suspect product.