Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Antinuclear antibody, Biopsy, Blood alkaline phosphatase, Blood bilirubin
Clinical narrative: hepatocellular pattern of liver injury; This is a literature report for:  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. There were no liver disease history.   The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as "hepatocellular pattern of liver injury". The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 1735 IU/l; antinuclear antibody: 1:320; biopsy: ++/+++, portal no interface hepatitis, notes: Inflammation severity, location; mixed infiltrate, notes: Cellular pattern of inflammation; none, neutrophilic peri-cholangitis, notes: Cholestasisd and bile duct features; blood alkaline phosphatase: 287 IU/l; blood bilirubin: 1.5 mg/dl; blood immunoglobulin g: negative; blood immunoglobulin m: negative; SARS-CoV-2 test: negative; imaging procedure: hepatic steatosis; international normalised ratio: 1.1; serology test: negative; varicella virus test: negative; viral load: 78. Therapeutic measures Oral prednisone were taken as a result of liver injury. Timing of pattern presentation of injury was 42 days in relation to first dose of vaccine. The author acknowledged that this series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, this report is not structured to evaluate potential causality. Drug induced liver injury is not readily implicated in this patient series, although it cannot be wholly excluded. The author also considered unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues. Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon, and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination. It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a possible causal relation between the event liver injury and the administration of the vaccine 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.,Linked Report(s) : 202101834329 Same article/drug/event and different patient