Received Dec 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
collapsed; internal bleed; This is a spontaneous report received from an Other HCP, Program ID. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27Sep2024 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CIRCULATORY COLLAPSE (hospitalization, medically significant) with onset 28Sep2024, outcome "unknown", described as "collapsed"; INTERNAL HAEMORRHAGE (hospitalization, medically significant) with onset 28Sep2024, outcome "unknown", described as "internal bleed". The events "collapsed" and "internal bleed" required physician office visit. Clinical course: Patient and her husband had received the vaccine together on the same day. Patient's husband had collapsed a day after receiving the COVID vaccine. He was hospitalized and an internal bleed was found. While there, patient had an episode of amnesia. Doctors determined as a combination of the vaccine and the stress of the situation with her husband, she may have experienced the amnesia episode.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events CIRCULATORY COLLAPSE, INTERNAL HAEMORRHAGE and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug 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.