Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Biopsy liver, Blood alkaline phosphatase, Blood bilirubin
Clinical narrative: Mild active hepatitis; Portal/periportal and perisinusoidal fibrosis; This literature-non-study case was reported in a literature article and describes the occurrence of HEPATITIS (Mild active hepatitis) and HEPATIC FIBROSIS (Portal/periportal and perisinusoidal fibrosis) in a 53-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.   On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEPATITIS (Mild active hepatitis) (seriousness criterion medically significant) and HEPATIC FIBROSIS (Portal/periportal and perisinusoidal fibrosis) (seriousness criterion medically significant). At the time of the report, HEPATITIS (Mild active hepatitis) and HEPATIC FIBROSIS (Portal/periportal and perisinusoidal fibrosis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: 1414 international unit per millilitre. On an unknown date, Aspartate aminotransferase: 1053 international unit per millilitre. On an unknown date, Biopsy liver: Histologic variations showed mild active hepatitis. Interface activity was negative. Portal/periportal and perisinusoidal fibrosis was noted.. On an unknown date, Blood alkaline phosphatase: 161 international unit per millilitre. On an unknown date, Blood bilirubin: 8.1 mg/dl. On an unknown date, Viral test: Negative.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered HEPATITIS (Mild active hepatitis) and HEPATIC FIBROSIS (Portal/periportal and perisinusoidal fibrosis) to be related.    Concomitant medications were not reported.  Patient received unspecified steroids as treatment medication.  Liver biopsies from patients with elevated liver enzymes clinically favored to be secondary to SARS-CoV-2 mRNA vaccine were identified between 2021 and 2022 from 3 institutions. Microscopic evaluation of the liver biopsies revealed various patterns of liver injury associated with the SARS-CoV-2 mRNA vaccines.  Clinical symptoms resolved spontaneously between 1 and 3 months after presentation. Normalization of liver enzymes occurred during several months. None of the patients in this study developed diseases of the biliary tract. In a rare instance, there was evidence of self-limiting hepatitis histologically demonstrating features of resolving hepatitis.  Author concluded that SARS-CoV-2 mRNA-based vaccines are predominantly associated with an active hepatitis pattern of liver injury. Less commonly observed patterns, such as cholestatic/biliary injury, should also be considered when evaluating liver biopsies in cases suspected of vaccine-induced liver injury. In rare instances, these vaccines may trigger underlying liver diseases.   This case was linked to US-MODERNATX, INC.-MOD-2024-774178 (E2B Linked Report).  Company Comment: This is a literature non-study case concerning a 53-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) events of Hepatitis and Hepatic fibrosis, which occurred 2 months after the second dose of SPIKEVAX COVID-19 VACCINE NOS. As reported, diagnostic tests resulted in: AST of 1053 IU/mL, ALT of 1414 IU/mL, alkaline phosphatase of 16.1 mg/dL, total bilirubin of 8.1. Patient was diagnosed after liver biopsy with mild active hepatitis, with portal/periportal and perisinusoidal fibrosis. Patient received steroid treatment and at the time of the report, the events had resolved. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774178:Master case (Patient 1)