Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Antimitochondrial antibody, Antinuclear antibody, Aspartate aminotransferase, Biliary obstruction
Clinical narrative: Mild bile duct injury; This literature-non-study case was reported in a literature article and describes the occurrence of BILIARY OBSTRUCTION (Mild bile duct injury) in a 66-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     The patient's past medical history included Jaundice (20 years prior). Concomitant products included ACETAMINOPHEN and CELECOXIB 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 BILIARY OBSTRUCTION (Mild bile duct injury) (seriousness criterion medically significant). At the time of the report, BILIARY OBSTRUCTION (Mild bile duct injury) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: 2217 international unit per millilitre. On an unknown date, Antimitochondrial antibody: Negative. On an unknown date, Antinuclear antibody: Positive. On an unknown date, Aspartate aminotransferase: 2664 international unit per millilitre. On an unknown date, Biopsy liver: Histologic Variations- Mild bile duct injury with minimal portal and lobular inflammation, Interface Activity- absent, Fibrosis-none. On an unknown date, Blood alkaline phosphatase: 2522 international unit per millilitre. On an unknown date, Blood bilirubin: 20.1 mg/dl. On an unknown date, Smooth muscle antibody: Negative. On an unknown date, Viral test: Negative.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered BILIARY OBSTRUCTION (Mild bile duct injury) 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 was prescribed with new medications low-dose acetaminophen, unspecified 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.  Company Comment:  This is a literature non-study case concerning a 66-year-old male patient, with relevant medical history of jaundice (20 years prior), who experienced the unexpected and serious (due to medically significant) event of Biliary obstruction, which occurred 1 month after the second dose of SPIKEVAX COVID-19 VACCINE NOS. As reported, the patient had AST of 2664 IU/mL, ALT of 2217 IU/mL, alkaline phosphatase of 2522 mg/dL, total bilirubin of 20.1. Anti-nuclear antibodies were positive; antimitochondrial antibodies and smooth muscle actin antibodies were negative. Patient was diagnosed after liver biopsy with mild bile duct injury. Patient received no treatment and at the time of the report, the event had resolved. Medical history of jaundice could be a confounding factor for the case. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS 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 3 from table 1(66 years Male)