Received Jan 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
Liver biopsy confirmed AIH; This is a literature report for the following literature source(s). An 18-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 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, life threatening), 2 weeks after the suspect product(s) administration, outcome "recovering", described as "Liver biopsy confirmed AIH". The patient underwent the following laboratory tests and procedures: Biopsy liver: confirmed AIH; Hepatic enzyme: elevated; Immunology test: positive. Therapeutic measures were taken as a result of autoimmune hepatitis. Clinical course: The patient developed symptoms 2 weeks post-Pfizer vaccine, presenting with jaundice, elevated liver enzymes, and positive autoimmune markers. Liver biopsy confirmed Autoimmune hepatitis (AIH), and the patient responded well to corticosteroids and azathioprine.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported event Autoimmune Hepatitis and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202600003311 Same article/drug and different patient/event;
Test Name: Liver biopsy; Result Unstructured Data: Test Result:confirmed AIH; Test Name: liver enzymes; Result Unstructured Data: Test Result:elevated; Test Name: autoimmune markers; Test Result: Positive