Received Mar 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
Per patient a couple of dates after getting the second dose of COVID-19 vaccine, developed blood clots in both her legs/ the "veins" still persist to this day; ASSESSMENT PROGRAM This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. An 85-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 20Apr2021, outcome "not recovered", described as "Per patient a couple of dates after getting the second dose of COVID-19 vaccine, developed blood clots in both her legs/ the "veins" still persist to this day". The event "per patient a couple of dates after getting the second dose of covid-19 vaccine, developed blood clots in both her legs/ the "veins" still persist to this day" required physician office visit. Clinical course: Per patient, a couple of days after getting the second dose of the COVID-19 vaccine, patient developed blood clots in both her legs. She saw the doctor regarding it. She stated the doctor mentioned those are blood clots but never gave her any medication to treat them and the "veins" still persist to this day. The reporter's assessment of the causal relationship of "per patient a couple of dates after getting the second dose of covid-19 vaccine, developed blood clots in both her legs/ the "veins" still persist to this day" 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 limited clinical information, lack of diagnostic confirmation, and presence of potential confounding factors such as advanced age, a causal relationship between BNT162b2 and the reported thrombosis cannot be established; therefore, the event is assessed as unrelated.