Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
stroke; Clot; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. An elderly female patient (not pregnant) 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. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), 10 days after the suspect product(s) administration, outcome "unknown", described as "stroke"; THROMBOSIS (medically significant), 10 days after the suspect product(s) administration, outcome "unknown", described as "Clot". It was unknown if therapeutic measures were taken as a result of cerebrovascular accident, thrombosis. Clinical course: an infection preventionist in a nursing home said that one her residents received Comminarty and 10 days later she had a clot and a stroke. The events were reported as non-serious. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.