Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, Laboratory test, Liver injury, Smooth muscle antibody, Viral test
Clinical narrative: hepatocellular pattern of liver injury; This is a literature report for the following literature source(s): "Liver injury following SARS-CoV-2 vaccination: A multicenter case series".  A 61-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; nitrofurantoin (NITROFURANTOIN) (Batch/Lot number: unknown) at unk (3-day course). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as " hepatocellular pattern of liver injury ". Timing of presentation (days) Pattern of injury in relation to first dose of vaccine is 34 days. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 2331 IU/l; biopsy: lymphocytes and plasma cells; none normal bile ducts; blood alkaline phosphatase: 160 IU/l; blood bilirubin: 3.7 mg/dl; inflammation scan: positive, notes: Portal and lobular No interface hepatitis; international normalised ratio: 1.3; laboratory test: negative; none; smooth muscle antibody: 1:160; viral test: negative. The action taken for nitrofurantoin was unknown. Therapeutic measures were taken as a result of liver injury with Oral prednisone. The patient had been prescribed a 3-day course of nitrofurantoin approximately 90 days prior to presentation. The scenario was deemed atypical for nitrofurantoin toxicity (particularly the short exposure and clinical presentation). 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 consider 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 batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal association between the events 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.,Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different Patient