Received Mar 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 3 | — | — |
blood clots in both legs and in his lungs; blood clots in both legs and in his lungs; unconsious; couldn't breathe; leg pain; This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. An 84-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: PULMONARY THROMBOSIS (hospitalization), THROMBOSIS (hospitalization) all with onset 17Jan2022, outcome "unknown" and all described as "blood clots in both legs and in his lungs"; DYSPNOEA (non-serious) with onset 17Jan2022, outcome "not recovered", described as "couldn't breathe"; PAIN IN EXTREMITY (non-serious) with onset 17Jan2022, outcome "not recovered", described as "leg pain"; LOSS OF CONSCIOUSNESS (hospitalization) with onset 17Jan2022, outcome "unknown", described as "unconsious". The patient was hospitalized for loss of consciousness (hospitalization duration: 14 day(s)). Clinical course: At the age of 83 years and 10 months, the patient received his third COVID-19 vaccine. A couple of months later, he began experiencing leg pain and struggled to breathe. He was hospitalized for two weeks and remained unconscious during that time. Medical evaluations revealed massive blood clots in both his legs and his lungs. The reporter's assessment of the causal relationship of "unconsious", "blood clots in both legs and in his lungs", "couldn't breathe" and "leg pain" 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 drug safety profile and limited information, a causal association between the suspect product and the reported events cannot be made at the moment, case to be reassessed once follow-up information becomes available.