Sex: M
Vaccine: COVID19
Symptoms: Hepatitis B surface antigen, Hepatitis C antibody, International normalised ratio, Investigation, Liver-kidney microsomal antibody
Clinical narrative: patient presenting with autoimmune hepatitis less than two weeks after receiving his first dose of the Pfizer covid-19 vaccine; Scleral icterus; This is a literature report for the following literature source(s):   A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pulmonary sarcoidosis" (unspecified if ongoing), notes: well controlled; "scleral icterus" (unspecified if ongoing), notes: 2 weeks after receiving his first dose of COVID-19 Pfizer vaccination; "liver problems" (unspecified if ongoing); "fatigue" (unspecified if ongoing), notes: he appeared fatigued with icteric sclera; "stomach upset" (unspecified if ongoing); "nausea" (unspecified if ongoing); "constipation" (unspecified if ongoing); "anorexia" (unspecified if ongoing); "lost 11 pounds" (unspecified if ongoing), notes: over a 2 month period; "jaundice began" (unspecified if ongoing), notes: with no improvement in transaminase values. The patient's concomitant medications were not reported. Past drug history included: Vitamins d3, reaction(s): "jaundice"; B12, reaction(s): "jaundice", notes: with no improvement in transaminase values; Echinacea supplements, reaction(s): "jaundice", notes: with no improvement in transaminase values. The following information was reported: AUTOIMMUNE HEPATITIS (medically significant), outcome "recovering", described as "patient presenting with autoimmune hepatitis less than two weeks after receiving his first dose of the Pfizer covid-19 vaccine"; OCULAR ICTERUS (medically significant), 2 weeks after the suspect product(s) administration, outcome "recovering", described as "Scleral icterus". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 1221, notes: Units: U/L; 1221, notes: Units: U/L; 118, notes: Units: IU/L; 1000s; with no improvement, notes: in transaminase values; Alpha-1 anti-trypsin: 208 mg/dl, notes: mildly elevated; Antimitochondrial antibody: were negative; Antinuclear antibody: direct was positive; Aspartate aminotransferase: 1177, notes: Units: U/L; 1234, notes: Units: U/L; 56, notes: Units: IU/mL; Biopsy: proven AIH just 13 days after receiving his first, notes: dose of the Pfizer COVID 19 vaccine; Biopsy liver: showed fulminant hepatitis with severe panlobular, notes: plasma cell-rich inflammation, extensive hepatocellular swelling, and frequent acidophil bodies; Blood alkaline phosphatase: 215 IU/l; Blood bilirubin: 7.2 mg/dl; 18.6 mg/dl, notes: (direct 14.8); Blood creatinine: 1.4 mg/dl; Blood immunoglobulin G: 3480, notes: was elevated; Blood iron: 256 ug/dL; Ceruloplasmin: was within normal range; Computerised tomogram abdomen: showed diminished attenuation of the liver, notes: suggesting steatosis; Gram stain: was consistentwith regenerative response; evidence of chronic injury and fibrosis but it was, notes: not clear whether this was true fibrosis or a result of his acute presentation; Haemoglobin: 13.8 g/dl; Hepatic enzyme: significant decrease in liver enzymes; complete normalization; Hepatitis A antibody: negative; Hepatitis B antibody: negative; Hepatitis B surface antigen: negative; Hepatitis C antibody: negative; International normalised ratio: 1.1; Abdominal examination: was grossly unremarkable; negative; Liver-kidney microsomal antibody: negative; Mean cell volume: 96, notes: Units: fL; physical examination: he appeared fatigued with icteric sclera; Platelet count: 267, notes: Units: K/cu mm; Serum ferritin: 3066 ng/ml; Smooth muscle antibody: weakly positive (1:22); Weight: lost 11 pounds over a 2-month period; White blood cell count: 6.9, notes: Units: K/cu mm; 22.4, notes: Units: K/cu mm. Therapeutic measures were taken as a result of ocular icterus.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the events autoimmune hepatitis, ocular icterus and suspect drug BNT162B2 cannot be excluded.   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.