Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alpha-1 anti-trypsin, Antimitochondrial antibody, Antinuclear antibody, Aspartate aminotransferase
Clinical narrative: Liver Injury; This literature-non-study case was reported in a literature article and describes the occurrence of LIVER INJURY (Liver Injury) in a 69-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.   LITERATURE REFERENCE:    The patient's past medical history included Cholecystectomy and Colonic polyp.    On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER INJURY (Liver Injury) (seriousness criteria hospitalization and medically significant). At the time of the report, LIVER INJURY (Liver Injury) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: normalization (One Month Later), 103 U/L and 448 U/L (one week after 1st lab) showed an upward trend.. On an unknown date, Alpha-1 anti-trypsin: Negative. On an unknown date, Antimitochondrial antibody: Negative. On an unknown date, Antinuclear antibody: Low positive ANA titer 1:80. On an unknown date, Aspartate aminotransferase: normalization (One Month Later), 121 U/L and 341 U/L (one week after 1st lab) showed an upward trend.. On an unknown date, Blood alkaline phosphatase: normalization (One Month Later), 136 U/L and 382 U/L (one week after 1st lab) showed an upward trend.. On an unknown date, Blood iron: Negative. On an unknown date, Ceruloplasmin: Negative. On an unknown date, Cytomegalovirus test: Negative. On an unknown date, Epstein-Barr virus test: 147 international unit per millilitre mildly positive but insignificant EBV PCR. On an unknown date, Hepatic enzyme: during admission showed improvement. On an unknown date, Hepatitis A virus test: Negative. On an unknown date, Hepatitis B virus test: Negative. On an unknown date, Hepatitis C virus test: Negative. On an unknown date, Herpes simplex test: Negative. On an unknown date, Serology test: (Negative) celiac serology. On an unknown date, Smooth muscle antibody: Negative. On an unknown date, Ultrasound abdomen: negative for  any significant finding. On an unknown date, Ultrasound liver: revealed patent hepatic and portal veins. On an unknown date, Varicella virus test: (Negative) Varicella zoster virus Negative.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered LIVER INJURY (Liver Injury) to be related.    Concomitant medication and treatment information were not provided.  Patient presented to her primary care office with fatigue, myalgia, and anorexia one week after receiving her fourth COVID-19 vaccination. Initial laboratory tests revealed elevated liver enzymes. Repeat labs after one week showed an upward trend, prompting her to be sent to the emergency department (ED). There was no sign of acute liver failure was noted. The patient denied alcohol use, intravenous drug use, tattoos, herbal supplements, or new medications. During her hospital admission, repeat laboratory tests showed an improvement in liver enzyme levels. She was discharged with instructions for outpatient follow-up. Although a liver biopsy was offered, the patient declined. One month later, repeat blood work showed near normalization of her ALT, AST, and ALP levels. It was reported that in this case, lab workup was insignificant other than ANA titers being mildly positive. Given the timeline it was likely her symptoms were secondary to the vaccine.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.