Sex: M
Vaccine: COVID19
Symptoms: Smooth muscle antibody
Clinical narrative: Autoimmune Hepatitis After COVID-19 Vaccine; This is a literature report.  An 18-year-old male patient received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (DOSE 1, SINGLE), administration date: Apr2021, for COVID-19 immunisation. The following information was reported: AUTOIMMUNE HEPATITIS (hospitalization, medically significant), 2 weeks after the suspect product(s) administration, outcome "recovered", described as "Autoimmune Hepatitis After COVID-19 Vaccine". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: (06Jun2021) 181 IU/l; (15Nov2021) 519 IU/l; (02Dec2021) 87 IU/l; (12Jan2022) 58 IU/l; (11Feb2022) 74 IU/l; (18Apr2022) 44 IU/l; (30May2022) 48 IU/l; Alpha-1 anti-trypsin: (unspecified date) unremarkable; Antinuclear antibody: (unspecified date) 1:640; Anti-soluble liver antigen/liver pancreas antibody: (unspecified date) 2.321; Aspartate aminotransferase: (06Jun2021) 120 IU/l; (15Nov2021) 323 IU/l; (02Dec2021) 31 IU/l; (12Jan2022) 35 IU/l; (11Feb2022) 48 IU/l; (18Apr2022) 37 IU/l; (30May2022) 50 IU/l; Biopsy liver: (unspecified date) with foci of interface and lobular hepatitis,, notes: areas of bridging necrosis, and scarring and focal nodularity concerning for transition to cirrhosis; Blood alkaline phosphatase: (06Jun2021) 265 IU/l; (15Nov2021) 292 IU/l; (02Dec2021) 165 IU/l; (12Jan2022) 101 IU/l; (11Feb2022) 109 IU/l; (18Apr2022) 116 IU/l; (30May2022) 124 IU/l; Blood immunoglobulin G: (unspecified date) 1845; Blood iron: (unspecified date) unremarkable; Ceruloplasmin: (unspecified date) unremarkable; Cytomegalovirus test: (unspecified date) unremarkable; (unspecified date) unremarkable; Epstein-Barr virus antibody: (unspecified date) unremarkable; (unspecified date) unremarkable; Hepatitis A: (unspecified date) unremarkable; Hepatitis B: (unspecified date) unremarkable; Hepatitis C: (unspecified date) unremarkable; Hepatitis E: (unspecified date) unremarkable; Liver function test: (unspecified date) normal, notes: prior liver chemistries were normal; Magnetic resonance imaging abdominal: (unspecified date) completed with findings of splenomegaly 20 cm, notes: radiographic evidence of advanced hepatic fibrosis; Platelet count: (06Jun2021) 90; (15Nov2021) 86; (02Dec2021) 93; (12Jan2022) 82; (11Feb2022) 96; (18Apr2022) 111; (30May2022) 98; Smooth muscle antibody: (unspecified date) 1:640, notes: positive. Therapeutic measures were taken as a result of autoimmune hepatitis. Clinical information: In Jun2021, about two weeks after the second dose, the patient was found with AST 120 u/L, ALT 181 u/L, Platelets 90. Per family, prior liver chemistries were normal. Initial serological workup was completed, including viral hepatitis (Hepatitis A, B, C, E), CMV IgG and IgM, EBV IgG and IgM, ceruloplasmin, alpha-1-antitrypsin, iron studies, all of which were unremarkable. Patient was also found to have ANA titer 1:640, positive anti-smooth-muscle antibody of 1:640, IgG level of 1,845, and positive antibody to soluble liver antigen of 2.321. Abdominal MRI was completed with findings of splenomegaly 20 cm, radiographic evidence of advanced hepatic fibrosis. Patient underwent a liver biopsy with foci of interface and lobular hepatitis, areas of bridging necrosis, and scarring and focal nodularity concerning for transition to cirrhosis. Given these findings and it's timing close to administration of COVID-19 vaccine, the patient was diagnosed with autoimmune hepatitis associated with the vaccine. Patient was started on steroids in Nov2021, and later, azathioprine, with improvement of liver enzymes.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (AUTOIMMUNE HEPATITIS) and BNT162B2. The 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 notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.