Received Jul 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
acute hepatitis with autoimmune features; The initial case was missing the following minimum criteria: unidentifiable reporter. Upon receipt of follow-up information on 28Jun2026, this case now contains all required information to be considered valid. This is a literature report, Program ID (withheld) for the following literature source(s). Since FDA's emergency use authorization (EUA) of BNT162b2 in December 2020 and approval in August 2021, however, there have been rare reports of hepatic injury arising within days or weeks of receipt of the vaccine. Likelihood score: C (probable, rare cause of clinically apparent liver injury). Acute liver injury after COVID-19 vaccination. A 35-year-old woman developed an acute hepatitis with autoimmune features 1 to 2 weeks after receiving a first dose of the Pfizer BNT162b2 COVID-19 vaccine. She was in general good health and was 3 months postpartum. Approximately one week after receiving the COVID-19 vaccine, she developed pruritus followed by dark urine and then jaundice. She had no history of liver disease, and her only medications were labetalol which had been started for gestation hypertension and was continued after delivery. She denied taking other medications including over-the-counter agents and herbal supplements. When seen in an emergency room approximately 13 days after vaccination, she was jaundiced and had mild hepatomegaly. Laboratory testing showed a total bilirubin of 4.8 mg/dL, ALT 2001 U/L, AST 754 U/L, and alkaline phosphatase 170 U/L. Tests for hepatitis A, B and C were negative as were tests for EBV, CMV, HSV1 and 2, and HIV infection. The ANA was strongly positive (1:1280) as were antibodies to double stranded DNA, while SMA, anti-LKM, ANCA and AMA were negative. Abdominal ultrasound was unremarkable, and endoscopic ultrasound showed no evidence of gallstones or biliary obstruction. A liver biopsy showed changes suggestive of autoimmune hepatitis with portal and lobular inflammation, focal necrosis, rosette formation, and marked interface hepatitis with lymphocytes, plasma cells and eosinophils. There were scant fibrosis and no evidence of cirrhosis. Over the first few hospital days, serum bilirubin remained elevated and aminotransferase levels fluctuated, decreasing minimally. Because of the autoantibodies and liver histology suggestive of an autoimmunity, prednisone [20 mg daily] was started. There was prompt improvement and when she was seen as an outpatient several weeks later, she was asymptomatic and liver tests were normal. The dose of prednisone was lowered and then stopped. Six weeks after stopping she remained asymptomatic and liver tests were normal. This was the initial case report of acute hepatitis with autoimmune features following and possibly caused by COVID-19 vaccination. In this case, a prudent dose of prednisone was used, which was then tapered and ultimately discontinued. In follow up, the patient remained in remission, although further monitoring would be appropriate, as late relapses can occur after stopping immunosuppression in patients with typical spontaneous autoimmune hepatitis. A central question is whether the episode represented vaccine induced liver injury with autoimmune features, or an autoimmune hepatitis triggered by the viral vaccine, or a coincidental occurrence of spontaneous autoimmune hepatitis that happened to become clinically evident shortly after vaccination (and a few months after pregnancy). The clinical features were typical of autoimmune hepatitis. Whether autoimmune hepatitis is triggered byCOVID-19 vaccination will require more experience with this complication as well as genetic and immunologic studies aimed at how vaccines stimulate autoimmunity. Thus, features of this syndrome suggest that the pathogenesis is indirect, caused by modulation of the immune system rather than direct although idiosyncratic injury to hepatocytes. Key Points are as follows: Medication: Pfizer BNT162.b2 COVID-19 vaccine. Pattern: Hepatocellular (R=38). Severity: 3+ (enzyme elevations, jaundice and hospitalization). Latency: 7 days to onset of symptoms, 13 days to presentation. Recovery: Within 2 months, on prednisone. Other medications: Labetalol (100 mg twice daily) for ~8 months. Laboratory Values: ALT Normal Value: <52 U/L, ALK P Normal Value: <117 (U/L), Bilirubin: <1.2 mg/dL. Time After Vaccine: 13 days, Time After Presentation: 0, ALT: 2001 U/L, Alk P: 170, Bilirubin (mg/dL): 4.8, Comments: Emergency Room. Time After Vaccine: 14 days, Time After Presentation: 1 day, ALT: 1746 U/L, Alk P: 183, Bilirubin (mg/dL): 5.7, Comments: Admission, Ultrasound. Time After Vaccine: 15 days, Time After Presentation: 2 days, ALT: 1629 U/L, Alk P: 171, Bilirubin (mg/dL): 5.4. Time After Vaccine: 16 days, Time After Presentation: 3 days, ALT: 1898 U/L, Alk P: 181, Bilirubin (mg/dL): 5.9, Comments: Liver Biopsy. Time After Vaccine: 17 days, Time After Presentation: 4 days, ALT: 1832 U/L, Alk P: 178, Bilirubin (mg/dL): 6.8. Time After Vaccine: 18 days, Time After Presentation: 5 days, ALT: 1375 U/L, Alk P: 153, Bilirubin (mg/dL): 6.0. Time After Vaccine: 19 days, Time After Presentation: 6 days, ALT: 1462 U/L, Alk P: 162, Bilirubin (mg/dL): 4.9, Comments: Prednisone started, discharge. Time After Vaccine: 24 days, Time After Presentation: 11 days, ALT: 501 U/L, Alk P: 127, Bilirubin (mg/dL): 1.6, Comments: Prednisone 20 mg/day. Time After Vaccine: 2 months, Time After Presentation: 6 weeks, ALT: 19 U/L, Alk P: 63, Bilirubin (mg/dL): 0.6, Comments: Prednisone 15 mg/day. Time After Presentation: 4 months, ALT: 17 U/L, Alk P: 57, Bilirubin (mg/dL): 0.6, Comments: Prednisone 10 mg/day. Time After Presentation: 6 months, ALT: 16 U/L, Alk P: 55, Bilirubin (mg/dL): 0.3, Comments: Prednisone 5 mg/day: stopped. Time After Presentation: 8 months, ALT: 13 U/L, Alk P: 67, Bilirubin (mg/dL): 0.4, Comments: Off of prednisone for 7 weeks.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product to the development of the reported event Autoimmune hepatitis 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
Gestational hypertension
Medical History/Concurrent Conditions: Postpartum state
LABETALOL
Test Name: ALT; Result Unstructured Data: Test Result:16 IU/l; Comments: Time After Presentation: 6 months ALT Normal Value: <52 U/L Comments: Prednisone 5 mg/day: stopped; Test Name: ALT; Result Unstructured Data: Test Result:13 IU/l; Comments: Time After Presentation: 8 months ALT Normal Value: <52 U/L Comments: Off of prednisone for 7 weeks; Test Date: 2021; Test Name: ALT; Result Unstructured Data: Test Result:17 IU/l; Comments: Time After Presentation: 4 months ALT Normal Value: <52 U/L Comments: Prednisone 10 mg/day; Test Date: 2021; Test Name: ALT; Result Unstructured Data: Test Result:2001 IU/l; Comments: Time After Vaccine: 13 days Time After Presentation: 0 ALT Normal Value: <52 U/L Comments: Emergency Room; Test Date: 2021; Test Name: ALT; Result Unstructured Data: Test Result:1746 IU/l; Comments: Time After Vaccine: 14 days Time After Presentation: 1 day ALT Normal Value: <52 U/L Comments: Admission, Ultrasound; Test Date: 2021; Test Name: ALT; Result Unstructured Data: Test Result:1629 IU/l; Comments: Time After Vaccine: 15 days Time After Presentation: 2 days ALT Normal Value: <52 U/L; Test Date: 2021; Test Name: ALT; Result Unstructured Data: Test Result:1898 IU/l; Comments: Time After Vaccine: 16 days Time After Presentation: 3 days ALT Normal Value: <52 U/L Comments: Liver Biopsy; Test Date: 2021; Test Name: ALT; Result Unstructured Data: Test Result:1832 IU/l; Comments: Time After Vaccine: 17 days Time After Presentation: 4 days ALT Normal Value: <52 U/L; Test Date: 2021; Test Name: ALT; Result Unstructured Data: Test Result:1375 IU/l; Comments: Time After Vaccine: 18 days Time After Presentation: 5 days ALT Normal Value: <52 U/LALT Normal Value: <52 U/L; Test Date: 2021; Test Name: ALT; Result Unstructured Data: Test Result:1462 IU/l; Comments: Time After Vaccine: 19 days Time After Presentation: 6 days ALT Normal Value: <52 U/L Comments: Prednisone started, discharge; Test Date: 2021; Test Name: ALT; Result Unstructured Data: Test Result:501 IU/l; Comments: Time After Vaccine: 24 days Time After Presentation: 11 days ALT Normal Value: <52 U/L Comments: Prednisone 20 mg/day; Test Date: 2021; Test Name: ALT; Result Unstructured Data: Test Result:19 IU/l; Comments: Time After Vaccine: 2 months Time After Presentation: 6 weeks ALT Normal Value: <52 U/L Comments: Prednisone 15 mg/day; Test Date: 2021; Test Name: AMA; Test Result: Negative ; Test Date: 2021; Test Name: ANCA; Test Result: Negative ; Test Date: 2021; Test Name: ANA; Result Unstructured Data: Test Result:strongly positive (1:1280); Test Date: 2021; Test Name: AST; Result Unstructured Data: Test Result:754 IU/l; Test Date: 2021; Test Name: liver biopsy; Result Unstructured Data: Test Result:changes suggestive of autoimmune hepatitis; Comments: with portal and lobular inflammation, focal necrosis, rosette formation, and marked interface hepatitis with lymphocytes, plasma cells and eosinophils; there was scant fibrosis and no evidence of cirrhosis; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:55 IU/l; Comments: Time After Presentation: 6 months ALT Normal Value: <52 U/L Comments: Prednisone 5 mg/day: stopped; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:67 IU/l; Comments: Time After Presentation: 8 months ALT Normal Value: <52 U/L Comments: Off of prednisone for 7 weeks; Test Date: 2021; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:57 IU/l; Comments: Time After Presentation: 4 months ALT Normal Value: <52 U/L Comments: Prednisone 10 mg/day; Test Date: 2021; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:170 IU/l; Comments: Time After Vaccine: 13 days Time After Presentation: 0 ALT Normal Value: <52 U/L Comments: Emergency Room; Test Date: 2021; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:183 IU/l; Comments: Time After Vaccine: 14 days Time After Presentation: 1 day ALT Normal Value: <52 U/L Comments: Admission, Ultrasound; Test Date: 2021; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:171 IU/l; Comments: Time After Vaccine: 15 days Time After Presentation: 2 days ALT Normal Value: <52 U/L; Test Date: 2021; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:181 IU/l; Comments: Time After Vaccine: 16 days Time After Presentation: 3 days ALT Normal Value: <52 U/L Comments: Liver Biopsy; Test Date: 2021; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:178 IU/l; Comments: Time After Vaccine: 17 days Time After Presentation: 4 days ALT Normal Value: <52 U/L; Test Date: 2021; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:153 IU/l; Comments: Time After Vaccine: 18 days Time After Presentation: 5 days ALT Normal Value: <52 U/LALT Normal Value: <52 U/L; Test Date: 2021; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:162 IU/l; Comments: Time After Vaccine: 19 days Time After Presentation: 6 days ALT Normal Value: <52 U/L Comments: Prednisone started, discharge; Test Date: 2021; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:127 IU/l; Comments: Time After Vaccine: 24 days Time After Presentation: 11 days ALT Normal Value: <52 U/L Comments: Prednisone 20 mg/day; Test Date: 2021; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:63 IU/l; Comments: Time After Vaccine: 2 months Time After Presentation: 6 weeks ALT Normal Value: <52 U/L Comments: Prednisone 15 mg/day; Test Date: 2021; Test Name: serum bilirubin; Result Unstructured Data: Test Result:elevated; Test Name: total bilirubin; Test Result: 0.3 mg/dl; Comments: Time After Presentation: 6 months ALT Normal Value: <52 U/L Comments: Prednisone 5 mg/day: stopped; Test Name: total bilirubin; Test Result: 0.4 mg/dl; Comments: Time After Presentation: 8 months ALT Normal Value: <52 U/L Comments: Off of prednisone for 7 weeks; Test Date: 2021; Test Name: total bilirubin; Test Result: 0.6 mg/dl; Comments: Time After Presentation: 4 months ALT Normal Value: <52 U/L Comments: Prednisone 10 mg/day; Test Date: 2021; Test Name: total bilirubin; Test Result: 4.8 mg/dl; Comments: Time After Vaccine: 13 days Time After Presentation: 0 ALT Normal Value: <52 U/L Comments: Emergency Room; Test Date: 2021; Test Name: total bilirubin; Test Result: 5.7 mg/dl; Comments: Time After Vaccine: 14 days Time After Presentation: 1 day ALT Normal Value: <52 U/L Comments: Admission, Ultrasound; Test Date: 2021; Test Name: total bilirubin; Test Result: 5.4 mg/dl; Comments: Time After Vaccine: 15 days Time After Presentation: 2 days ALT Normal Value: <52 U/L; Test Date: 2021; Test Name: total bilirubin; Test Result: 5.9 mg/dl; Comments: Time After Vaccine: 16 days Time After Presentation: 3 days ALT Normal Value: <52 U/L Comments: Liver Biopsy; Test Date: 2021; Test Name: total bilirubin; Test Result: 6.8 mg/dl; Comments: Time After Vaccine: 17 days Time After Presentation: 4 days ALT Normal Value: <52 U/L; Test Date: 2021; Test Name: total bilirubin; Test Result: 6.0 mg/dl; Comments: Time After Vaccine: 18 days Time After Presentation: 5 days ALT Normal Value: <52 U/LALT Normal Value: <52 U/L; Test Date: 2021; Test Name: total bilirubin; Test Result: 4.9 mg/dl; Comments: Time After Vaccine: 19 days Time After Presentation: 6 days ALT Normal Value: <52 U/L Comments: Prednisone started, discharge; Test Date: 2021; Test Name: total bilirubin; Test Result: 1.6 mg/dl; Comments: Time After Vaccine: 24 days Time After Presentation: 11 days ALT Normal Value: <52 U/L Comments: Prednisone 20 mg/day; Test Date: 2021; Test Name: total bilirubin; Test Result: 0.6 mg/dl; Comments: Time After Vaccine: 2 months Time After Presentation: 6 weeks ALT Normal Value: <52 U/L Comments: Prednisone 15 mg/day; Test Date: 2021; Test Name: CMV; Test Result: Negative ; Test Date: 2021; Test Name: antibodies to double stranded DNA; Test Result: Positive ; Test Date: 2021; Test Name: endoscopic ultrasound; Result Unstructured Data: Test Result:no evidence of gallstones or biliary obstruction; Test Date: 2021; Test Name: EBV; Test Result: Negative ; Test Date: 2021; Test Name: hepatitis A; Test Result: Negative ; Test Date: 2021; Test Name: hepatitis B; Test Result: Negative ; Test Date: 2021; Test Name: hepatitis C; Test Result: Negative ; Test Date: 2021; Test Name: HSV1; Test Result: Negative ; Test Date: 2021; Test Name: HSV2; Test Result: Negative ; Test Date: 2021; Test Name: HIV infection test; Test Result: Negative ; Test Date: 2021; Test Name: anti-LKM; Test Result: Negative ; Test Date: 2021; Test Name: autoantibodies histology; Result Unstructured Data: Test Result:suggestive of an autoimmunity; Test Date: 2021; Test Name: liver histology; Result Unstructured Data: Test Result:suggestive of an autoimmunity; Test Date: 2021; Test Name: SMA; Test Result: Negative ; Test Date: 2021; Test Name: aminotransferase levels; Result Unstructured Data: Test Result:fluctuated, decreasing minimally; Test Date: 2021; Test Name: liver tests; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: liver tests; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: Abdominal ultrasound; Result Unstructured Data: Test Result:unremarkable