Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / LA |
placecd on a ventilator for 11 days; stroke; blood clots in legs/lung; blood clots in legs/lung; bad cough/difficulty breathing; bad cough; bed sores; This is a spontaneous report received from an Other HCP, Program ID. A 69-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Influenza (seasonal) (fluad) (Manufacturer: Seqirus, Inc., Route: Intramuscular, Body Site: Left Arm), for Immunization. The following information was reported: DECUBITUS ULCER (non-serious) with onset 2024, outcome "recovered" (Dec2024), described as "bed sores"; COUGH (non-serious) with onset 08Oct2024, outcome "unknown", described as "bad cough"; DYSPNOEA (non-serious) with onset 08Oct2024, outcome "unknown", described as "bad cough/difficulty breathing"; THROMBOSIS (medically significant), PULMONARY THROMBOSIS (medically significant) all with onset 08Oct2024, outcome "unknown" and all described as "blood clots in legs/lung"; CEREBROVASCULAR ACCIDENT (hospitalization, medically significant, life threatening) with onset Oct2024, outcome "unknown", described as "stroke"; DEPENDENCE ON RESPIRATOR (hospitalization, medically significant, life threatening), outcome "unknown", described as "placecd on a ventilator for 11 days". The events "stroke", "placecd on a ventilator for 11 days", "blood clots in legs/lung", "bad cough/difficulty breathing" and "bad cough" required physician office visit and emergency room visit. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Based on the limited available information, the causal association between the events Cerebrovascular accident, thrombosis, pulmonary thrombosis and the suspect product BNT162b2 omicron (kp.2) can not be excluded. The event dependence on respirator is most likely related to an underlying condition and is not related to the suspect drug BNT162b2 omicron (kp.2). 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.