Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood bilirubin, Hepatitis, Smooth muscle antibody
Clinical narrative: Severe active hepatitis; This literature-non-study case was reported in a literature article and describes the occurrence of HEPATITIS (Severe active hepatitis) in a 31-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     Concomitant products included ETONOGESTREL for an unknown indication.   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,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced HEPATITIS (Severe active hepatitis) (seriousness criterion medically significant). At the time of the report, HEPATITIS (Severe active hepatitis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: 1512 international unit per millilitre. On an unknown date, Antinuclear antibody: Positive. On an unknown date, Aspartate aminotransferase: 783 international unit per millilitre. On an unknown date, Biopsy liver: histologic variation showed acute hepatitis. Interface activity was positive. No signs of fibrosis.. On an unknown date, Blood alkaline phosphatase: 141 international unit per millilitre. On an unknown date, Blood bilirubin: 3.1 mg/dl. On an unknown date, Smooth muscle antibody: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered HEPATITIS (Severe active hepatitis) to be related.    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.  Drug-induced liver injury was considered unlikely after consideration of dosage and timing of the medications by the treating hepatologists. The patient did not receive any treatment and clinical symptoms resolved spontaneously between 1 and 3 months after presentation. Normalization of liver enzymes occurred during several months. Patient had prescribed with new medications low-dose acetaminophen, opioids, and celecoxib.  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.  The patient did not receive any treatment and her condition resolved spontaneously.  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.  Company Comment: This literature-non-study case concerns a 31-year-old female patient, with no history of liver disease and on etonogestrel reported as new medications, who experienced the unexpected and serious (medically significant) event of hepatitis, four days after the second dose of SPIKEVAX NOS (SPIKEVAX NOS) vaccine. She experienced jaundice, pruritus, fever, nausea, fatigue, and epigastric pain. Laboratory findings included AST 783IU/ml, ALT 1512 IU/ml, alkaline phosphatase 141 IU/ml, total bilirubin 3.1 mg/dL. Positive titers for autoimmune antibodies were detected (anti-nuclear and antimitochondrial). Viral serologies were negative. A liver biopsy revealed severe active hepatitis with present interface activity but with no fibrosis. Clinical symptoms resolved spontaneously. History of etonogestrel remains as a confounder for the event, however drug-induced liver injury was considered unlikely after consideration of dosage and timing of the medications by the treating hepatologists. No further clinical information was available for medical review. The benefit-risk relationship of SPIKEVAX NOS (SPIKEVAX NOS) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-774178 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774178:Patient 6 (31 years Female)