Received Jun 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
autoimmune hepatitis after receiving a SARS-CoV-2 mRNA vaccine; This is a literature report for the following literature source(s). The demographics and clinical characteristics of the patients were presented . The majority of the patients were female (8 of 12; 67%) and (redacted) (9 of 12; 75%), with an age range between 29 and 79 years (redacted, 58 years). Five patients received the mRNA-1273 (Moderna) vaccine and 7 patients received the BNT162b2 (Pfizer BioNTech) vaccine. Ten patients received at least 2 doses of the SARSCoV-2 mRNA vaccines and 2 patients received only 1 dose. Four of 12 patients (33%) had a prior history of liver disease, including jaundice, steatosis, cirrhosis secondary to metabolic dysfunction-associated steatohepatitis complicated by hepatocellular carcinoma, and autoimmune hepatitis. Nine of 12 patients (75%) presented with symptoms including jaundice, pruritus, fever, nausea, fatigue, and epigastric pain. Three of 12 patients (25%) were asymptomatic, and they had all received the BNT162b2 vaccine. Eleven of the 12 patients (92%) had significantly elevated liver enzymes that prompted liver biopsies. Two of the 3 asymptomatic patients (67%) had elevated liver enzymes that were identified on routine laboratory testing for annual wellness visits. The third asymptomatic patient had a history of liver transplantation and mildly elevated alanine transaminase; this biopsy was done as routine follow-up to monitor the liver allograft. Clinical symptoms for the 9 patients began between 1 day and 2 months after receiving the vaccine dose. Two of 12 patients (17%) developed symptoms after the first dose, 5 (42%) developed symptoms after the second dose, and 2 patients (17%) developed symptoms after the third dose. All symptomatic patients (n = 9) and 1 asymptomatic patient had elevated aspartate transaminase and/or alanine transaminase greater than 1000 IU/mL. Positive titers for autoimmune antibodies were detected in all but one of the patients for whom serologic data were available (9 of 10 patients; 90%). Viral serologies available for 9 of 9 patients (100%) were negative. Three of 12 patients (25%) reported new medications: 1 had been prescribed low-dose acetaminophen, opioids, and celecoxib; another was on etonogestrel; and the third was on baby aspirin. However, drug-induced liver injury was considered unlikely after consideration of dosage and timing of the medications by the treating hepatologists. Eight of 12 patients (67%) received steroid treatment and 4 of 12 (33%) received no treatment. Clinical symptoms resolved spontaneously (n = 4) or after steroid therapy (n = 8) between 1 and 3 months after presentation. Normalization of liver enzymes occurred during several months. One patient was eventually diagnosed with autoimmune hepatitis, and another was later diagnosed with celiac disease and sarcoidosis.; Sender's Comments: The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Test Name: ALT; Result Unstructured Data: Test Result:2366 IU/ml; Test Name: autoimmune antibodies; Test Result: Positive ; Comments: For smooth muscle actin antibodies; Test Name: AST; Result Unstructured Data: Test Result:1974 IU/ml; Test Name: Liver biopsy; Result Unstructured Data: Test Result:Histologic variations of liver injury in biopsy; Comments: specimens showed Cholestatic injury and moderate active hepatitis and positive interface activity; Test Name: Liver biopsy; Result Unstructured Data: Test Result:initial biopsy was prompted by elevated liver; Comments: enzymes noted about a month after the second dose of the SARS-CoV-2 mRNA vaccine, and it showed the cholestatic pattern of injury with only minimal portal and lobular inflammation.; Test Name: Liver biopsy; Result Unstructured Data: Test Result:second liver biopsy, conducted 6 weeks later; Comments: without intervening treatment, showed morphologic features inconsistent with cholestatic pattern of injury, but consistent with moderate active hepatitis, characterized by plasma cell-rich portal inflammation with interface activity, suggestive of an autoimmune-like pattern of liver injury; Test Name: Liver biopsy; Result Unstructured Data: Test Result:third biopsy persistently showed histologic; Comments: features of autoimmune-like liver injury, culminating in a clinical diagnosis of autoimmune hepatitis; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:160 IU/ml; Test Name: Total bilirubin; Test Result: 3.4 mg/dl; Test Name: Liver enzyme; Result Unstructured Data: Test Result:elevated; Comments: noted about a month after the second dose of the SARS-CoV-2 mRNA vaccine; Test Name: Histology; Result Unstructured Data: Test Result:Unknown result; Test Name: Interface activity; Test Result: Positive ; Test Name: Microscopic evaluation; Result Unstructured Data: Test Result:Unknown result; Test Name: Viral Serology; Test Result: Negative