Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatitis, Liver function test, Ultrasound liver
Clinical narrative: liver inflammation/elevated liver enzymes /elevated again/stomach pain/sensation abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of HEPATITIS (liver inflammation/elevated liver enzymes /elevated again/stomach pain/sensation abdominal pain) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014c21a, 018f21a and 031B21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: ISONIAZID in 2006. Past adverse reactions to the above products included Adverse reaction with ISONIAZID.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEPATITIS (liver inflammation/elevated liver enzymes /elevated again/stomach pain/sensation abdominal pain) (seriousness criterion medically significant). At the time of the report, HEPATITIS (liver inflammation/elevated liver enzymes /elevated again/stomach pain/sensation abdominal pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Liver function test: liver enzymes specifically my AST and ALT. were significantly elevated. On 10-May-2021, Ultrasound liver: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HEPATITIS (liver inflammation/elevated liver enzymes /elevated again/stomach pain/sensation abdominal pain) to be related.    No concomitant drug information was provided.  Patient had a similar reaction to a drug (isoniazid) in 2006. Reporter reported a general summary of liver inflammation after the Moderna vaccine. Patient didn't notice any adverse reaction after the first dose. Patient had received the second dose of vaccine roughly 32 days after dose 1 and 3 days later after the dose 2, on 10May2021, patient went to the hospital for sensation abdomen pain and the hospital performed some blood tests (unknown results) and liver function test. In addition to it, it was reported that, in the hospital they checked everything else, and it was all negative. Since then, patient had 15 liver tests and the liver function returns to normal within 30 days each time, function comes back to normal. After the first booster dose, it came back to normal again.  Reporter further reported that as per his assumption would be that each the patient received the injection of Moderna it had affected his liver and each time the liver got self-healing.  No treatment medication was reported by the patient.  Company Comment: This spontaneous case concerns a 48-year-old male patient,  with no medical history reported, who experienced the unexpected  serious (medically significant) event of Hepatitis that occurred 3 days after receiving the second dose of mRNA-1273 vaccine in the Covid-19 vaccination series. Patient had received first and second dose of Moderna vaccine at an interval of 32days,  third dose 7 months later and bivalent booster dose approximately one year after third dose.Patient experienced elevated liver enzymes after each dose of Moderna vaccine, AST and ALT were significantly elevated after the second dose. It was reported that, Patient had received Isoniazid (unknown dose and frequency) that caused similar reaction, which remains as a  confounder for the event. No further information on risk factors, clinical course, medical history, investigations and treatment received were provided. The outcome of the event was recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-686388 (Patient Link).; Sender's Comments: This spontaneous case concerns a 48-year-old male patient,  with no medical history reported, who experienced the unexpected  serious (medically significant) event of Hepatitis that occurred 3 days after receiving the second dose of mRNA-1273 vaccine in the Covid-19 vaccination series. Patient had received first and second dose of Moderna vaccine at an interval of 32days,  third dose 7 months later and bivalent booster dose approximately one year after third dose.Patient experienced elevated liver enzymes after each dose of Moderna vaccine, AST and ALT were significantly elevated after the second dose. It was reported that, Patient had received Isoniazid (unknown dose and frequency) that caused similar reaction, which remains as a  confounder for the event. No further information on risk factors, clinical course, medical history, investigations and treatment received were provided. The outcome of the event was recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.