Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis, Smooth muscle antibody
Clinical narrative: Moderate to severe active hepatitis; This literature-non-study case was reported in a literature article and describes the occurrence of HEPATITIS (Moderate to severe active hepatitis) in a 68-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.   LITERATURE REFERENCE:      The patient's past medical history included Autoimmune hepatitis.   On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and 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 (Moderate to severe active hepatitis) (seriousness criterion medically significant). At the time of the report, HEPATITIS (Moderate to severe active hepatitis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: 1199 international unit per millilitre. On an unknown date, Aspartate aminotransferase: 1140 international unit per millilitre. On an unknown date, Biopsy liver: Histologic Variations- Moderate to Severe active hepatitis, Interface Activity- present, Fibrosis-none. On an unknown date, Blood alkaline phosphatase: 352 international unit per millilitre. On an unknown date, Blood bilirubin: 4.9 mg/dl. On an unknown date, Smooth muscle antibody: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered HEPATITIS (Moderate to severe active hepatitis) to be related.    Concomitant medications were not reported. Patient was treated with unspecified steroids.  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. 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.  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 concerning a 68-year-old, female patient with medical history of Autoimmune hepatitis, who experienced the unexpected serious (medically significant) event of hepatitis (reported as moderate to severe active hepatitis) which occurred two days after the administration of the third dose of SPIKEVAX COVID-19 VACCINE NOS vaccine. Investigation done indicated significantly elevated levels of alanine aminotransferase (1199 IU/L) and aspartate aminotransferase (1140 IU/L), indicating substantial liver damage. The liver biopsy indicated moderate to severe active hepatitis with interface activity but no fibrosis. Blood bilirubin is elevated at 4.9 mg/dL, and blood alkaline phosphatase was notably high at 352 IU/L and positive smooth muscle antibody. Patient was treated with unspecified steroids. Outcome reported as resolved. No further details were provided at this time. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS Vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774178:Patient 7 (68 years Female)