Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune hepatitis, Biopsy liver, Biopsy skin, Blood alkaline phosphatase, Blood bilirubin
Clinical narrative: Autoimmune hepatitis; A biopsy of the rash revealed LCV; systemic lupus erythematosus; This literature-non-study case was reported in a literature article and describes the occurrence of AUTOIMMUNE HEPATITIS (Autoimmune hepatitis), CUTANEOUS VASCULITIS (A biopsy of the rash revealed LCV) and SYSTEMIC LUPUS ERYTHEMATOSUS (systemic lupus erythematosus) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   The patient's past medical history included Cholecystectomy. Concurrent medical conditions included Morbid obesity, Hypertension, Coronary artery disease and Lung disease (Hypersensitivity lung disease).    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE HEPATITIS (Autoimmune hepatitis) (seriousness criterion medically significant), CUTANEOUS VASCULITIS (A biopsy of the rash revealed LCV) (seriousness criterion medically significant) and SYSTEMIC LUPUS ERYTHEMATOSUS (systemic lupus erythematosus) (seriousness criterion medically significant). The patient was treated with AZATHIOPRINE for COVID-19 prophylaxis, at an unspecified dose and frequency. At the time of the report, AUTOIMMUNE HEPATITIS (Autoimmune hepatitis) was resolving and CUTANEOUS VASCULITIS (A biopsy of the rash revealed LCV) and SYSTEMIC LUPUS ERYTHEMATOSUS (systemic lupus erythematosus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: 259 U/L. On an unknown date, Alpha-1 anti-trypsin: Negative. On an unknown date, Antimitochondrial antibody: Negative. On an unknown date, Antinuclear antibody: 1:1280 titer. On an unknown date, Aspartate aminotransferase: 382 U/L. On an unknown date, Biopsy liver: revealed lymphoplasmacytic infiltrate and interface hepatitis that were compatible with autoimmune hepatitis. On an unknown date, Biopsy skin: biopsy of the rash revealed leucocytic vasculitis (LCV). On an unknown date, Blood alkaline phosphatase: 224 U/L. On an unknown date, Blood bilirubin: 1.9 mg/dl. On an unknown date, Blood immunoglobulin G: 2815 mg/dl. On an unknown date, Ceruloplasmin: Negative. On an unknown date, Complement factor: low. On an unknown date, Cytomegalovirus test: Negative. On an unknown date, Double stranded DNA antibody: Positive. On an unknown date, Laboratory test: Negative. On an unknown date, Physical examination: was notable only for a petechial rash involving both legs. On an unknown date, Serum ferritin: Negative. On an unknown date, Smooth muscle antibody: Negative. On an unknown date, Ultrasound abdomen: RUQ ultrasound revealed no evidence of biliary obstruction and mild CBD dilation due to cholecystectomy. On an unknown date, Viral test: Negative.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.  Company Comment: This is a literature non-study case concerning a 59-year-old, female patient with a medical history of cholecystectomy, and concurrent medical conditions of Morbid obesity, Hypertension, Coronary artery disease and Lung disease (Hypersensitivity lung disease), who experienced the unexpected AESI (due to medically significant autoimmune hepatitis, the unexpected AESI cutaneous vasculitis (Leukocytoclastic vasculitis)  and the unexpected adverse event systemic lupus erythematosus. The event occurred 10 days after receiving a dose of mRNA-1273 vaccine (dose number and event date were not provided). Patient presented to the emergency department, complained of petechial rash and fatigue that developed 10 days after receiving the COVID vaccine. Both rash and liver injury improved with steroid administration but worsened with tapering. Patient's liver injury improved with IV steroids, and patient was then transitioned to azathioprine and tapered off steroids without further flares. The diagnosis of autoimmune hepatitis was not able to be confirmed until the liver biopsy. Patient received 7 points for the IAHG AIH diagnostic criteria, indicated definitive autoimmune hepatitis. Relevant diagnostic tests included Alanine aminotransferase of 259 U/L, Aspartate aminotransferase of 382 U/L, Antinuclear antibody of 1:1280 titer, Blood alkaline phosphatase of 224 U/L, Blood bilirubin of 1.9 mg/dl, and Blood immunoglobulin G of 2815 mg/dl (reference ranges not provided). Celiac panel, Antimitochondrial antibody, Alpha-1 anti-trypsin, Ceruloplasmin, Cytomegalovirus test, Serum ferritin, Smooth muscle antibody and Viral hepatitis tests resulted Negative. A Biopsy of liver revealed lymphoplasmacytic infiltrate and interface hepatitis that were compatible with autoimmune hepatitis and a Biopsy of skin rash revealed leucocytic vasculitis (LCV). Double stranded DNA antibody test resulted Positive and low complement was found. Physical examination was notable only for a petechial rash involving both legs. Ultrasound of abdomen revealed no evidence of biliary obstruction and mild CBD dilation due to cholecystectomy. No concomitant medications were reported. The patient was treated with azathioprine for COVID-19 prophylaxis, at an unspecified dose and frequency. At the time of the report, the outcome of the events was reported as unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   No concomitant medications were reported.  Patient presented to the emergency department, complained of petechial rash and fatigue that developed 10 days after receiving the COVID vaccine. Both rash and liver injury improved with steroid administration but worsened with tapering. Patient's liver injury improved with IV steroids, and patient was then transitioned to azathioprine and tapered off steroids without further flares. The diagnosis of autoimmune hepatitis was not able to be confirmed until the liver biopsy. Patient received 7 points for the IAHG AIH diagnostic criteria, indicated definitive AIH.   Authors reported that this case report added to this small but growing series of patients who developed autoimmune hepatitis after receiving a COVID-19 vaccine. Because of vaccine hesitancy, providers must be able to have an informed discussion with patients about the benefits and risks. This case highlighted the need for greater awareness on the part of clinicians of this rare complication.; Sender's Comments: Company Comment: This is a literature non-study case concerning a 59-year-old, female patient with a medical history of cholecystectomy, and concurrent medical conditions of Morbid obesity, Hypertension, Coronary artery disease and Lung disease (Hypersensitivity lung disease), who experienced the unexpected AESI (due to medically significant autoimmune hepatitis, the unexpected AESI cutaneous vasculitis (Leukocytoclastic vasculitis)  and the unexpected adverse event systemic lupus erythematosus. The event occurred 10 days after receiving a dose of mRNA-1273 vaccine (dose number and event date were not provided). Patient presented to the emergency department, complained of petechial rash and fatigue that developed 10 days after receiving the COVID vaccine. Both rash and liver injury improved with steroid administration but worsened with tapering. Patient's liver injury improved with IV steroids, and patient was then transitioned to azathioprine and tapered off steroids without further flares. The diagnosis of autoimmune hepatitis was not able to be confirmed until the liver biopsy. Patient received 7 points for the IAHG AIH diagnostic criteria, indicated definitive autoimmune hepatitis. Relevant diagnostic tests included Alanine aminotransferase of 259 U/L, Aspartate aminotransferase of 382 U/L, Antinuclear antibody of 1:1280 titer, Blood alkaline phosphatase of 224 U/L, Blood bilirubin of 1.9 mg/dl, and Blood immunoglobulin G of 2815 mg/dl (reference ranges not provided). Celiac panel, Antimitochondrial antibody, Alpha-1 anti-trypsin, Ceruloplasmin, Cytomegalovirus test, Serum ferritin, Smooth muscle antibody and Viral hepatitis tests resulted Negative. A Biopsy of liver revealed lymphoplasmacytic infiltrate and interface hepatitis that were compatible with autoimmune hepatitis and a Biopsy of skin rash revealed leucocytic vasculitis (LCV). Double stranded DNA antibody test resulted Positive and low complement was found. Physical examination was notable only for a petechial rash involving both legs. Ultrasound of abdomen revealed no evidence of biliary obstruction and mild CBD dilation due to cholecystectomy. No concomitant medications were reported. The patient was treated with azathioprine for COVID-19 prophylaxis, at an unspecified dose and frequency. At the time of the report, the outcome of the events was reported as unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.