Received Jun 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
aggressive cancer; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-019505 (BioNTech). 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: NEOPLASM MALIGNANT (death), outcome "fatal", described as "aggressive cancer". The patient date of death was unknown. Reported cause of death: "aggressive cancer". It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. COMIRNATY is under agreement with BIONTECH SE.; Reported Cause(s) of Death: aggressive cancer