Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Diagnosed with autoimmune hepatitis; Date of 1st Moderna dose: 11Aug2021 Lot # 002F21A Date of 2nd Moderna dose: 17Sep2021 Lot # 047621A; This spontaneous case was reported by a health care professional and describes the occurrence of AUTOIMMUNE HEPATITIS (Diagnosed with autoimmune hepatitis) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A and 047621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. It was unknown if patient ever had COVID positive test or diagnosis. Previously administered products included for Product used for unknown indication: shingrix vaccine (Reaction in either 2017 or 2018 shingrix vaccine). Past adverse reactions to the above products included Reaction to previous exposure to any vaccine with shingrix vaccine. Concurrent medical conditions included Hypertension, Seizure, Sulfonamide allergy and Atopic dermatitis.  On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Date of 1st Moderna dose: 11Aug2021 Lot # 002F21A Date of 2nd Moderna dose: 17Sep2021 Lot # 047621A). In January 2022, the patient experienced AUTOIMMUNE HEPATITIS (Diagnosed with autoimmune hepatitis) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE HEPATITIS (Diagnosed with autoimmune hepatitis) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Date of 1st Moderna dose: 11Aug2021 Lot # 002F21A Date of 2nd Moderna dose: 17Sep2021 Lot # 047621A) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Alanine aminotransferase: 700-800 (High) Test Result: Liver enzymes AST, ALT 700-800. Diagnosed with autoimmune hepatitis.. In October 2021, Aspartate aminotransferase: 700-800 (High) Test Result: Liver enzymes AST, ALT 700-800. Diagnosed with autoimmune hepatitis.. In October 2021, Hepatic enzyme: 200-300 (High) Test Result: Liver enzymes elevated to 200-300. Diagnosed with autoimmune hepatitis.. On an unknown date, Antinuclear antibody: positive (Positive) Test Result: Positive ANA.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medication was reported. It was reported that there was ongoing waves of nausea, fatigue, right quadrant pain over liver. After 2 weeks of 2nd dose patient had severe nausea and was in bed for 2 weeks. In Oct-2021, patient went to doctor and liver enzymes went out the roof elevated to 200-300 then by end of Oct-2021 liver enzymes AST, ALT 700-800. It was diagnosed with autoimmune hepatitis around Jan-2022. States she had a positive ANA lab test and plans to see rheumatologist to determine cause of positive ANA , states liver enzymes were now back to normal. Patient had constant fatigue, waves of nausea and still had right quadrant pain says most likely from liver. No treatment medication information provided.  Company comment: This spontaneous case concerns a 57-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) adverse event of special interest Autoimmune hepatitis, with symptoms of persistent nausea, fatigue and right quadrant pain. Inappropriate schedule of product administration was reported as an additional event wherein dosing interval of the mRNA-1273 primary series was 37 days - more than the recommended vaccination window. The event was diagnosed approximately 4 months after receiving the second dose of mRNA-1273. The patient initially presented with severe nausea 2 weeks post-vaccination. She sought medical consult wherein liver enzymes were reportedly elevated, AST and ALT at 700-800 values (unspecified unit), and positive ANA test. Treatment details were not provided in the case; but the liver enzymes reportedly went back to normal on an unspecified date. The patient is yet to schedule a rheumatologist consult for further etiologic investigations. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 57-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) adverse event of special interest Autoimmune hepatitis, with symptoms of persistent nausea, fatigue and right quadrant pain. Inappropriate schedule of product administration was reported as an additional event wherein dosing interval of the mRNA-1273 primary series was 37 days - more than the recommended vaccination window. The event was diagnosed approximately 4 months after receiving the second dose of mRNA-1273. The patient initially presented with severe nausea 2 weeks post-vaccination. She sought medical consult wherein liver enzymes were reportedly elevated, AST and ALT at 700-800 values (unspecified unit), and positive ANA test. Treatment details were not provided in the case; but the liver enzymes reportedly went back to normal on an unspecified date. The patient is yet to schedule a rheumatologist consult for further etiologic investigations. The benefit-risk relationship of mRNA-1273 is not affected by this report.