Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Biopsy, Blood alkaline phosphatase, Blood bilirubin, International normalised ratio
Clinical narrative: hepatocellular pattern of liver injury; This is a literature report for the following literature source(s): (privacy) A 33 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "autoimmune hepatitis" (ongoing), notes: in treated remission (no medication changes or abnormal labs for a minimum of 6 months); "Compensated cirrhosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovered", described as "hepatocellular pattern of liver injury". The patient had pre-existing AIH and displayed interface activity, demonstrated a significant plasma cell component. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 173 IU/l; biopsy: inflammation severity: +/++, notes: Portal and lobular with interface hepatitis; lymphocytes and plasma cells, notes: Cellular pattern of inflammation; none, normal bile ducts, notes: Cholestasis and bile duct features; cirrhosis, notes: Fibrosis; blood alkaline phosphatase: 46 IU/l; blood bilirubin: 2.1 mg/dl; international normalised ratio: 1.1; fibrous connective tissue: cirrhosis; sars-cov-2 test: negative. Therapeutic measure Oral prednisone were taken as a result of liver injury. Timing of pattern presentation of injury was 28 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 information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Liver injury.  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.