Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis viral test, Liver function test, Liver-kidney microsomal antibody, Physical examination, Smooth muscle antibody
Clinical narrative: Vaccine-induced (AIH) Autoimmune hepatitis- like syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of AUTOIMMUNE HEPATITIS (Vaccine-induced (AIH) Autoimmune hepatitis- like syndrome) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     Concurrent medical conditions included Depression. Concomitant products included SERTRALINE for Depression.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced AUTOIMMUNE HEPATITIS (Vaccine-induced (AIH) Autoimmune hepatitis- like syndrome) (seriousness criterion medically significant). The patient was treated with BUDESONIDE at a dose of 9 milligram once a day. At the time of the report, AUTOIMMUNE HEPATITIS (Vaccine-induced (AIH) Autoimmune hepatitis- like syndrome) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: 2035 U/L. On an unknown date, Antimitochondrial antibody: Negative. On an unknown date, Antinuclear antibody: (Positive) 1:320. On an unknown date, Aspartate aminotransferase: 1377 U/L. On an unknown date, Biopsy liver: revealed portal, peri-portal, and lobular inflammation consisting of lymphocytic infiltrates, focally prominent plasma cells, and ceroid-laden macrophages. On an unknown date, Blood alkaline phosphatase: 435 U/L. On an unknown date, Blood bilirubin: 3.8 mg/dl. On an unknown date, Ceruloplasmin: levels were normal. On an unknown date, Epstein-Barr virus test: Negative. On an unknown date, Hepatitis viral test: Negative. On an unknown date, Liver function test: improvement after the treatment. On an unknown date, Liver-kidney microsomal antibody: Negative. On an unknown date, Physical examination: jaundiced with mild right upper quadrant tenderness. On an unknown date, Smooth muscle antibody: Negative. On an unknown date, Ultrasound abdomen: showed hepatic steatosis without cholelithiasis or biliary dilatation.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered AUTOIMMUNE HEPATITIS (Vaccine-induced (AIH) Autoimmune hepatitis- like syndrome) to be related.    It was reported that, one week post-vaccination, patient developed severe fatigue, myalgia, and arthralgia and noted jaundice, upper abdominal discomfort, and dark urine one month post-vaccination.  Patient did not use herbal remedies or alcohol.  It was reported that ?1-antitrypsin levels were normal and pathology was compatible with AIH.  Authors concluded that, while the causality of the vaccine leading to AIH was not established, the absence of hepatotoxic agents, negative viral serology, supportive histology, and response to treatment in our case suggest the association was not a mere coincidence. Clinicians should be vigilant for vaccine-induced AIH in patients who received vaccination and present with jaundice and abdominal pain in the setting of elevated liver enzymes.  Company Comment: This is a literature non-study case concerning a 56-year-old, female patient with concurrent medical condition of Depression and concomitant product of sertraline for Depression, who experienced the unexpected AESI (due to medically significant) autoimmune hepatitis (reported as Vaccine-induced Autoimmune hepatitis- like syndrome). Patient did not use herbal remedies or alcohol. The event occurred one week after receiving the second dose of mRNA-1273 vaccine. On week after vaccination, patient developed severe fatigue, myalgia, and arthralgia and noted jaundice, upper abdominal discomfort, and dark urine one month post-vaccination. Relevant diagnostic tests included Alanine aminotransferase of 2035 U/L, Aspartate aminotransferase of 1377 U/L., Antinuclear antibody (positive) of 1:320 titer, Blood alkaline phosphatase of 435 U/L and Blood bilirubin of 3.8 mg/dl (reference ranges were not provided). It was reported that ceruloplasmin and ?1-antitrypsin levels were normal, and pathology was compatible with autoimmune hepatitis. Anti-mitochondrial antibody, Epstein-Barr virus test, Hepatitis viral test, anti-Liver-kidney microsomal antibody, and Smooth muscle antibody resulted Negative. A Biopsy of liver revealed portal, peri-portal, and lobular inflammation consisting of lymphocytic infiltrates, focally prominent plasma cells, and ceroid-laden macrophages. Physical examination revealed jaundiced with mild right upper quadrant tenderness. Ultrasound of abdomen showed hepatic steatosis without cholelithiasis or biliary dilatation.  The patient was treated with budesonide and liver function test showed improvement after treatment. At the time of the report, the event was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company Comment: This is a literature non-study case concerning a 56-year-old, female patient with concurrent medical condition of Depression and concomitant product of sertraline for Depression, who experienced the unexpected AESI (due to medically significant) autoimmune hepatitis (reported as Vaccine-induced Autoimmune hepatitis- like syndrome). Patient did not use herbal remedies or alcohol. The event occurred one week after receiving the second dose of mRNA-1273 vaccine. On week after vaccination, patient developed severe fatigue, myalgia, and arthralgia and noted jaundice, upper abdominal discomfort, and dark urine one month post-vaccination. Relevant diagnostic tests included Alanine aminotransferase of 2035 U/L, Aspartate aminotransferase of 1377 U/L., Antinuclear antibody (positive) of 1:320 titer, Blood alkaline phosphatase of 435 U/L and Blood bilirubin of 3.8 mg/dl (reference ranges were not provided). It was reported that ceruloplasmin and ?1-antitrypsin levels were normal, and pathology was compatible with autoimmune hepatitis. Anti-mitochondrial antibody, Epstein-Barr virus test, Hepatitis viral test, anti-Liver-kidney microsomal antibody, and Smooth muscle antibody resulted Negative. A Biopsy of liver revealed portal, peri-portal, and lobular inflammation consisting of lymphocytic infiltrates, focally prominent plasma cells, and ceroid-laden macrophages. Physical examination revealed jaundiced with mild right upper quadrant tenderness. Ultrasound of abdomen showed hepatic steatosis without cholelithiasis or biliary dilatation.  The patient was treated with budesonide and liver function test showed improvement after treatment. At the time of the report, the event was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.