Received Mar 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
stroke; heart failure ef factor lowered; had bad eye bleed; struggle continually with HBP; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) 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), outcome "unknown", described as "stroke"; HEART FAILURE WITH REDUCED EJECTION FRACTION (medically significant), outcome "unknown", described as "heart failure ef factor lowered"; EYE HAEMORRHAGE (non-serious), outcome "unknown", described as "had bad eye bleed"; HYPERTENSION (non-serious), outcome "not recovered", described as "struggle continually with HBP". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.