Report #2881588

Overview

Sex

Female

Age

65 yrs

State

—

Recovered

Not recovered

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (3)

Symptom narrative

Autoimmune Hepatitis Post COVID-19 Vaccination; This literature-non-study case was reported in a literature article and describes the occurrence of AUTOIMMUNE HEPATITIS (Autoimmune Hepatitis Post COVID-19 Vaccination) in a 65-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 vaccination. LITERATURE REFERENCE: No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE HEPATITIS (Autoimmune Hepatitis Post COVID-19 Vaccination) (seriousness criterion medically significant). The patient was treated with Prednisone at an unspecified dose and frequency. At the time of the report, AUTOIMMUNE HEPATITIS (Autoimmune Hepatitis Post COVID-19 Vaccination) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: were significantly elevated. On an unknown date, Smooth muscle antibody: Positive. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. This study represented patients who developed Autoimmune hepatitis (AIH) shortly after COVID-19 vaccination, detailing clinical presentations, serological findings, and therapeutic responses. The patient experienced acute hepatitis within days of receiving the Moderna vaccine. Patient showed improvement with prednisone. The author stated that AIH post-COVID-19 vaccination remained an uncommon but significant observation. The case involved a temporal association between vaccination and onset of symptoms, raising questions of causality versus coincidence. Though vaccines might theoretically induce autoimmune conditions by molecular mimicry or immune system activation, the benefits of vaccination outweigh potential risks for most populations. This case suggested a need for vigilant monitoring, particularly in individuals with known autoimmune predispositions. Whilst causation could be confirmed, these findings underscore the importance in post-vaccination monitoring for liver-related symptoms. Further research was warranted to elucidate underlying mechanisms and to determine whether specific vaccines or demographic factors increase susceptibility. This case was linked to US-MODERNATX, INC.-MOD-2026-793115 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2026-793115:82 year female patient 3 from the article

Lab data

Test Name: liver enzymes; Result Unstructured Data: were significantly elevated; Test Name: Smooth muscle antibodies; Test Result: Positive