Received Aug 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
multiple strokes; inoperable brain blockage; asthma; a bit of arm pain after vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (has had multiple doses of the Covid 19 Vaccine every 6 months for a couple of years. Unknown dose number, Unknown manufacturer.), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "not recovered", described as "multiple strokes"; CEREBRAL INFARCTION (medically significant), outcome "not recovered", described as "inoperable brain blockage"; ASTHMA (non-serious), outcome "not recovered"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "a bit of arm pain after vaccines". Therapeutic measures were taken as a result of cerebrovascular accident, cerebral infarction, asthma. Clinical information: On 18Aug2025, it was reported that caller stated patient had multiple strokes, had an inoperable brain blockage and asthma. Patient was taking multiple medications for her conditions and has had multiple doses of the Covid 19 Vaccine every 6 months for a couple of years, caller indicated a bit of arm pain after vaccines. Created AE due to existing conditions as well as interaction with other medications. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The events Stroke and Brain infarction are considered unrelated to the suspect drug, as it is explained by an alternative mechanism unrelated to the pharmacological action of the drug. 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