Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme, Hepatic function abnormal, Hepatitis, Laboratory test
Clinical narrative: Severe non-cholestatic hepatitis; She never developed hepatic dysfunction; This spontaneous case was reported by a physician and describes the occurrence of HEPATITIS (Severe non-cholestatic hepatitis) and HEPATIC FUNCTION ABNORMAL (She never developed hepatic dysfunction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATITIS (Severe non-cholestatic hepatitis) (seriousness criterion medically significant) and HEPATIC FUNCTION ABNORMAL (She never developed hepatic dysfunction) (seriousness criterion medically significant). At the time of the report, HEPATITIS (Severe non-cholestatic hepatitis) and HEPATIC FUNCTION ABNORMAL (She never developed hepatic dysfunction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: improving (High) liver enzymes are improving and she never developed hepatic dysfunction.. On an unknown date, Laboratory test: normal (normal) Lab tests has otherwise been normal with no clear cause..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HEPATITIS (Severe non-cholestatic hepatitis) to be related. No further causality assessment was provided for HEPATIC FUNCTION ABNORMAL (She never developed hepatic dysfunction).    I have a patient who developed severe non-cholestatic hepatitis, diagnosed about 2 weeks after dose one of her Moderna Vaccine. Lab testing has otherwise been normal with no clear cause. She was on a large volume of supplements and herbs. I believe that was the culprit or possibly an undiagnosed transient viral infection. However the patient is slightly overdue to dose #2 and is worried. Her liver enzymes are improving and she never developed hepatic dysfunction. I could find no data in the literature about case reports of vaccine induced hepatitis. I have asked her to delay dose #2 for another week. Please let me know if you have any guidance for me. She was on a large volume of supplements and herbs. However, the patient was slightly overdue to dose 2 and was worried. She never developed hepatic dysfunction. Doctor had asked her to delay dose 2 for another week.  No concomitant medications were reported. No treatment information was provided. Company comment  This case concerns a female patient of an unknown age, with medical history of consumer of large volume of supplements and herbs, who experienced the unexpected serious events of HEPATITIS and HEPATIC FUNCTION ABNORMAL. The events occurred approximately 2 weeks after the administration of the first dose of mRNA-1273 vaccine. Patient´s medical history of consumer of large volume of supplements and herbs, remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age, with medical history of consumer of large volume of supplements and herbs, who experienced the unexpected serious events of HEPATITIS and HEPATIC FUNCTION ABNORMAL. The events occurred approximately 2 weeks after the administration of the first dose of mRNA-1273 vaccine. Patient´s medical history of consumer of large volume of supplements and herbs, remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.