Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
CVA; uncontrolled type 2 DM; atherosclerotic CVD; This is a spontaneous report received from a Physician. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: CEREBROVASCULAR ACCIDENT (death, hospitalization), outcome "fatal", described as "CVA"; TYPE 2 DIABETES MELLITUS (death, hospitalization), outcome "fatal", described as "uncontrolled type 2 DM"; ARTERIOSCLEROSIS (death, hospitalization), outcome "fatal", described as "atherosclerotic CVD". Therapeutic measures were taken as a result of cerebrovascular accident, type 2 diabetes mellitus, arteriosclerosis. The patient date of death was Feb2021. Reported cause of death: "CVA", "uncontrolled type 2 DM", "atherosclerotic CVD". It was not reported if an autopsy was performed. Clinical course: HCP is Nephrologist is a large private practice. One of his HD patients developed a CVA 5 weeks after Cormirnaty. He ascribes this to the vaccine and did not take into account uncontrolled type 2 DM and atherosclerotic CVD as potential confounding factors. Ae resulted in: Hospitalization, Patient died. Date of death: Feb2021. If autopsy performed: Unknown. If treatment AE: Yes. AE treatment: Details not known The information on the batch/lot number for [BNT162B2 OMICRON (LP.8.1)] will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events cerebrovascular accident, type 2 diabetes mellitus, and arteriosclerosis; and the suspect drug BNT162B2 OMICRON (LP.8.1) cannot be excluded. The case will be reassessed once new information is available. 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.; Reported Cause(s) of Death: CVA; uncontrolled type 2 DM; atherosclerotic CVD