Received May 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
acute hepatitis; jaundice; dark urine; mild hepatomegaly; ANA was strongly positive (1:1280); antibodies to double stranded DNA.; pruritus; This is a literature report, Program ID: for the following literature source(s): A 35-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LABETALOL HYDROCHLORIDE taken for gestational hypertension (ongoing). The following information was reported: HEPATITIS ACUTE (hospitalization, medically significant), outcome "recovered", described as "acute hepatitis"; JAUNDICE (hospitalization), outcome "recovered"; CHROMATURIA (non-serious), outcome "unknown", described as "dark urine"; HEPATOMEGALY (non-serious), outcome "unknown", described as "mild hepatomegaly"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious), outcome "unknown", described as "ANA was strongly positive (1:1280)"; DOUBLE STRANDED DNA ANTIBODY POSITIVE (non-serious), outcome "unknown", described as "antibodies to double stranded DNA."; PRURITUS (non-serious), 1 week after the suspect product(s) administration, outcome "unknown". The events "jaundice" and "mild hepatomegaly" required emergency room visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: aminotransferase levels fluctuated,, notes: decreasing minimally; Alanine aminotransferase: 2001 IU/l, notes: 13 days, Time after presentation: 0 days, Emergency Room; 1746 IU/l, notes: 14 days, Time after presentation: 1 days, Admission, Ultrasound; 1629 IU/l, notes: 15 days, Time after presentation: 2 days; 1898 IU/l, notes: 16 days, Time after presentation: 3 days; 1832 IU/l, notes: 17days, Time after presentation: 4 days; 1375 IU/l, notes: 18 days, Time after presentation: 5 days; 1462 IU/l, notes: 19 days, Time after presentation: 6 days, Prednisone started, discharge; 501 IU/l, notes: 24 days, Time after presentation: 11 days, Prednisone 20 mg/day; 19 IU/l, notes: 2 months, Time after presentation: 6 weeks, Prednisone 15 mg/day; 17 IU/l, notes: Time after presentation: 4 months, Prednisone 10 mg/day; 16 IU/l, notes: Time after presentation: 6 months, Prednisone 5 mg/day: stopped; 13 IU/l, notes: Time after presentation: 8 months, Off of prednisone for 7 weeks; Antinuclear antibody: 1:1280, notes: strongly positive; Aspartate aminotransferase: aminotransferase levels fluctuated,, notes: decreasing minimally; Aspartate aminotransferase: 754 IU/l; Biopsy liver: showed changes suggestive of autoimmune hepatitis, notes: 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; Unknown results; Blood alkaline phosphatase: 170 IU/l, notes: Time after vaccine: 13 days, Time after presentation: 0, Emergency Room; 183 IU/l, notes: Time after vaccine: 14 days, Time after presentation: 1 day; 171 IU/l, notes: Time after vaccine: 15 days, Time after presentation: 2 days; 181 IU/l, notes: Time after vaccine: 16 days, Time after presentation: 3 days; 178 IU/l, notes: Time after vaccine: 17 days, Time after presentation: 4 days; 153 IU/l, notes: Time after vaccine: 18 days, Time after presentation: 5 days; 162 IU/l, notes: Time after vaccine: 19 days, Time after presentation: 6 days, Prednisone started, discharge; 127 IU/l, notes: Time after vaccine: 24 days, Time after presentation: 24 days, Prednisone 20 mg/day; 63 IU/l, notes: Time after vaccine: 2 months, Time after presentation: 6 weeks, Prednisone 10 mg/day; 57 IU/l, notes: Time after presentation: 4 months, Prednisone 10 mg/day; 55 IU/l, notes: Time after presentation: 6 months, Prednisone 5 mg/day: stopped; 67 IU/l, notes: Time after presentation: 8 months, Off of prednisone for 7 weeks; Blood bilirubin: 4.8 mg/dl, notes: Time after vaccine: 13 days, Time after presentation: 0, Emergency Room; 5.7 mg/dl, notes: Time after vaccine: 14 days, Time after presentation: 1 day; 5.4 mg/dl, notes: Time after vaccine: 15 days, Time after presentation: 2 days; 5.9 mg/dl, notes: Time after vaccine: 16 days, Time after presentation: 3 days; 6.8 mg/dl, notes: Time after vaccine: 17 days, Time after presentation: 4 days; 6.0 mg/dl, notes: Time after vaccine: 18 days, Time after presentation: 5 days; 4.9 mg/dl, notes: Time after vaccine: 19 days, Time after presentation: 6 days, Prednisone started, discharge; 1.6 mg/dl, notes: Time after vaccine: 19 days, Time after presentation: 6 days, Prednisone started, discharge; 0.6 mg/dl, notes: Time after vaccine: 2 months, Time after presentation: 6 weeks, Prednisone 10 mg/day; 0.6 mg/dl, notes: Time after presentation: 4 months, Prednisone 10 mg/day; 0.3 mg/dl, notes: Time after presentation: 6 months, Prednisone 5 mg/day: stopped; 0.4 mg/dl, notes: Time after presentation: 8 months, Off of prednisone for 7 weeks; remained elevated; Double stranded DNA antibody: Positive; Endoscopic ultrasound: no evidence of gallstones or biliary obstruction; Enzyme level test: elevations; Hepatitis viral test: negative, notes: tests for EBV, CMV, HSV1 and 2, and HIV infection; SMA, anti-LKM, ANCA and AMA: negative; Liver function test: normal; Ultrasound scan: Abdominal ultrasound was unremarkable; Unknown results. Therapeutic measures were taken as a result of hepatitis acute, jaundice. Clinical course: Acute liver injury after COVID-19 vaccination. (Patient developed an acute hepatitis with autoimmune features 1 to 2 weeks after receiving a first dose of the Pfizer BNT162b2 COVID-19 vaccine. One week after receiving the COVID-19 vaccine, she developed pruritus followed by dark urine and then jaundice. Her only medications were labetalol for gestation hypertension and was continued after delivery. 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. No follow-up attempts are possible.; Sender's Comments: Based on the current information provided in the case, the possibility that the events HEPATITIS ACUTE, JAUNDICE are related to the suspect drug administration cannot be totally 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.
LABETALOL HYDROCHLORIDE
Test Name: ALT; Result Unstructured Data: Test Result:aminotransferase levels fluctuated,; Comments: decreasing minimally; Test Name: ALT; Result Unstructured Data: Test Result:2001 IU/l; Comments: 13 days, Time after presentation: 0 days, Emergency Room; Test Name: ALT; Result Unstructured Data: Test Result:1746 IU/l; Comments: 14 days, Time after presentation: 1 days, Admission, Ultrasound; Test Name: ALT; Result Unstructured Data: Test Result:1629 IU/l; Comments: 15 days, Time after presentation: 2 days; Test Name: ALT; Result Unstructured Data: Test Result:1898 IU/l; Comments: 16 days, Time after presentation: 3 days; Test Name: ALT; Result Unstructured Data: Test Result:1832 IU/l; Comments: 17days, Time after presentation: 4 days; Test Name: ALT; Result Unstructured Data: Test Result:1375 IU/l; Comments: 18 days, Time after presentation: 5 days; Test Name: ALT; Result Unstructured Data: Test Result:1462 IU/l; Comments: 19 days, Time after presentation: 6 days, Prednisone started, discharge; Test Name: ALT; Result Unstructured Data: Test Result:501 IU/l; Comments: 24 days, Time after presentation: 11 days, Prednisone 20 mg/day; Test Name: ALT; Result Unstructured Data: Test Result:19 IU/l; Comments: 2 months, Time after presentation: 6 weeks, Prednisone 15 mg/day; Test Name: ALT; Result Unstructured Data: Test Result:17 IU/l; Comments: Time after presentation: 4 months, Prednisone 10 mg/day; Test Name: ALT; Result Unstructured Data: Test Result:16 IU/l; Comments: Time after presentation: 6 months, Prednisone 5 mg/day: stopped; Test Name: ALT; Result Unstructured Data: Test Result:13 IU/l; Comments: Time after presentation: 8 months, Off of prednisone for 7 weeks; Test Name: ANA; Result Unstructured Data: Test Result:1:1280; Comments: strongly positive; Test Name: AST; Result Unstructured Data: Test Result:aminotransferase levels fluctuated,; Comments: decreasing minimally; Test Name: AST; Result Unstructured Data: Test Result:754 IU/l; Test Name: liver biopsy; Result Unstructured Data: Test Result:showed 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: liver biopsy; Result Unstructured Data: Test Result:Unknown results; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:170 IU/l; Comments: Time after vaccine: 13 days, Time after presentation: 0, Emergency Room; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:183 IU/l; Comments: Time after vaccine: 14 days, Time after presentation: 1 day; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:171 IU/l; Comments: Time after vaccine: 15 days, Time after presentation: 2 days; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:181 IU/l; Comments: Time after vaccine: 16 days, Time after presentation: 3 days; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:178 IU/l; Comments: Time after vaccine: 17 days, Time after presentation: 4 days; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:153 IU/l; Comments: Time after vaccine: 18 days, Time after presentation: 5 days; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:162 IU/l; Comments: Time after vaccine: 19 days, Time after presentation: 6 days, Prednisone started, discharge; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:127 IU/l; Comments: Time after vaccine: 24 days, Time after presentation: 24 days, Prednisone 20 mg/day; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:63 IU/l; Comments: Time after vaccine: 2 months, Time after presentation: 6 weeks, Prednisone 10 mg/day; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:57 IU/l; Comments: Time after presentation: 4 months, Prednisone 10 mg/day; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:55 IU/l; Comments: Time after presentation: 6 months, Prednisone 5 mg/day: stopped; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:67 IU/l; Comments: Time after presentation: 8 months, Off of prednisone for 7 weeks; Test Name: total bilirubin; Test Result: 4.8 mg/dl; Comments: Time after vaccine: 13 days, Time after presentation: 0, Emergency Room; Test Name: total bilirubin; Test Result: 5.7 mg/dl; Comments: Time after vaccine: 14 days, Time after presentation: 1 day; Test Name: total bilirubin; Test Result: 5.4 mg/dl; Comments: Time after vaccine: 15 days, Time after presentation: 2 days; Test Name: total bilirubin; Test Result: 5.9 mg/dl; Comments: Time after vaccine: 16 days, Time after presentation: 3 days; Test Name: total bilirubin; Test Result: 6.8 mg/dl; Comments: Time after vaccine: 17 days, Time after presentation: 4 days; Test Name: total bilirubin; Test Result: 6.0 mg/dl; Comments: Time after vaccine: 18 days, Time after presentation: 5 days; Test Name: total bilirubin; Test Result: 4.9 mg/dl; Comments: Time after vaccine: 19 days, Time after presentation: 6 days, Prednisone started, discharge; Test Name: total bilirubin; Test Result: 1.6 mg/dl; Comments: Time after vaccine: 19 days, Time after presentation: 6 days, Prednisone started, discharge; Test Name: total bilirubin; Test Result: 0.6 mg/dl; Comments: Time after vaccine: 2 months, Time after presentation: 6 weeks, Prednisone 10 mg/day; Test Name: total bilirubin; Test Result: 0.6 mg/dl; Comments: Time after presentation: 4 months, Prednisone 10 mg/day; Test Name: total bilirubin; Test Result: 0.3 mg/dl; Comments: Time after presentation: 6 months, Prednisone 5 mg/day: stopped; Test Name: total bilirubin; Test Result: 0.4 mg/dl; Comments: Time after presentation: 8 months, Off of prednisone for 7 weeks; Test Name: total bilirubin; Result Unstructured Data: Test Result:remained elevated mg/dl; Test Name: antibodies to double stranded DNA; Test Result: Positive ; Test Name: endoscopic ultrasound; Result Unstructured Data: Test Result:no evidence of gallstones or biliary obstruction; Test Name: enzyme; Result Unstructured Data: Test Result:elevations; Test Name: Tests for hepatitis A, B and C; Test Result: Negative ; Comments: tests for EBV, CMV, HSV1 and 2, and HIV infection; Test Name: SMA, anti-LKM, ANCA and AMA; Test Result: Negative ; Test Name: liver tests; Result Unstructured Data: Test Result:normal; Test Name: ultrasound; Result Unstructured Data: Test Result:Abdominal ultrasound was unremarkable; Test Name: ultrasound; Result Unstructured Data: Test Result:Unknown results