Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Biopsy liver, Blood alkaline phosphatase, Hepatic enzyme
Clinical narrative: Autoimmune Hepatitis Flare; This is a literature report for the following literature source(s).  A 41-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lupus" (unspecified if ongoing); "autoimmune hepatitis" (unspecified if ongoing), notes: consistent. responsive to a stable regimen of prednisone and MMF for eight month. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (unknown manufacturer)), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE (unknown manufacturer)), for covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE (unknown manufacturer)), for covid-19 immunization.  The following information was reported: HEPATITIS (medically significant), 3 weeks after the suspect product(s) administration, outcome "recovered", described as "Autoimmune Hepatitis Flare". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 464, notes: increase from normal the month before; Aspartate aminotransferase: 344, notes: increase from normal the month before; Biopsy liver: consistent with autoimmune hepatitis; Blood alkaline phosphatase: 265, notes: increase from normal the month before; Hepatic enzyme: elevated, notes: on yearly labs; normalized; lab: consistent with autoimmune hepatitis; Liver function test: consistent with autoimmune hepatitis. Therapeutic measures were taken as a result of hepatitis.  Clinical course: The patient with a past medical history of lupus was found to have elevated liver enzymes on yearly labs. This patient's lab and liver biopsy results were consistent with autoimmune hepatitis. She was responsive to a stable regimen of prednisone and MMF for eight months. However, three weeks following her fourth COVID Pfizer vaccine, her routine labs exhibited AST: 344, ALT: 464, and alkaline phosphatase: 265. These values were a significant increase from normal the month before. This necessitated up-titration of prednisone and MMF, which normalized her liver enzymes within two months. This case demonstrate that COVID vaccination may play a role in autoimmune hepatitis flares. This can be a challenging situation for many clinicians to navigate, as COVID remains a significant threat to patients' health, and there are many case reports that show that COVID infection itself can precede a flare. Patients with autoimmune liver disease may benefit from closer laboratory evaluation surrounding COVID vaccination.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event hepatitis and suspect BNT162B2 cannot be excluded.This impact of this report on the benefit/risk profile of the Pfizer product 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300199136 Same article/ drug/event and different patient;US-PFIZER INC-PV202300091486 Same article/ drug/event and different patient;