Received Aug 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
lupus; cancer; diarrhea; The initial case was missing the following minimum criteria: Unidentifiable reporter. Upon receipt of follow-up information on (03Feb2025), this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP. 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: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.