Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Biopsy, Blood alkaline phosphatase, Blood bilirubin, Hepatitis
Clinical narrative: hepatocellular pattern of liver injury; Portal and lobular with interface hepatitis; new diagnosis of solitary hepatocellular carcinoma; This is a literature report.  A 68 year-old male 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 "recovering", described as "hepatocellular pattern of liver injury"; HEPATITIS (medically significant), outcome "recovering", described as "Portal and lobular with interface hepatitis"; HEPATOCELLULAR CARCINOMA (medically significant), outcome "recovering", described as "new diagnosis of solitary hepatocellular carcinoma". The patient had pre-existing autoimmune hepatitis and displayed interface activity, demonstrated a significant plasma cell component. Timing of pattern presentation of injury was 19 days in relation to first dose of vaccine. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 245 IU/l; biopsy: inflammation severity: moderate, notes: Portal and lobular with interface hepatitis; mixed with plasma cells, notes: Cellular pattern of inflammation; normal bile ducts; blood alkaline phosphatase: 55 IU/l; blood bilirubin: 0.9 mg/dl; imaging procedure: new diagnosis of solitary hepatocellular carcinoma; international normalised ratio: 1.1; fibrous connective tissue: cirrhosis. Therapeutic measures Oral prednisone were taken as a result of liver injury, hepatitis, hepatocellular carcinoma. 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: As per available information in the case provided, the causal association between the event liver injury, hepatitis, and hepatocellular carcinoma and the 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.,Linked Report(s) : 202101834329 Same article/drug/event and different patient.