Received May 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Autoimmune hepatitis; This is a spontaneous report received from a consumer, 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: AUTOIMMUNE HEPATITIS (medically significant), outcome "unknown". The patient had been recently diagnosed with autoimmune hepatitis and believed he/she got it from the COVID-19 vaccines (as reported) the patient received. The information on the batch/lot number for BNT162b2 Omicron (KP.2) will be requested and submitted if and when received.