Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hepatic enzyme, Hepatic failure, Hepatic steatosis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC FAILURE (has liver failure and does not process stomach acids/ dyspepsia (heartburn), pain (heartburn pain), hepatic pain, liver disorder (liver discomfort), rash, rash macular) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Seafood allergy (Allergy to Marsico) and Glucose intolerance (hereditary problems with glucose). Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), HYOSCYAMINE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, MAGNESIUM TRISILICATE (TUMS [CALCIUM CARBONATE; MAGNESIUM CARBONATE; MAGNESIUM TRISILICATE]), ALUMINUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED; MAGNESIUM CARBONATE]) and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEPATIC FAILURE (has liver failure and does not process stomach acids/ dyspepsia (heartburn), pain (heartburn pain), hepatic pain, liver disorder (liver discomfort), rash, rash macular) (seriousness criterion medically significant) and HEPATIC STEATOSIS (Fatty liver). At the time of the report, HEPATIC FAILURE (has liver failure and does not process stomach acids/ dyspepsia (heartburn), pain (heartburn pain), hepatic pain, liver disorder (liver discomfort), rash, rash macular) and HEPATIC STEATOSIS (Fatty liver) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: high (High) high. Patient reported that two weeks after getting the second dose of the Moderna Covid-19 vaccine got spot like chickenpox in their chest and stomach but no pain. 4 months later patient started getting heartburn pain, a rush on their wrist. He also had pain in the liver after vaccination, fatty liver and liver discomfort. Patient had liver failure and does not process stomach acids. Adverse event caused patient to have office visit, patient did not experienced a similar event in the past and patient stated that symptoms worsened. No treatment medication details provided. Company comment: This is a spontaneous case concerning a 39-year-old, male patient with relevant medical history of unspecified hereditary problems with glucose, who experienced the unexpected serious (medically significant) AESI event of hepatic failure and unexpected serious (medically significant) event of hepatic steatosis. The events exact occurrence was unknown but stated that the events occurred after the second dose of mRNA-1273 vaccine administration. Allegedly the events were described as, 2 weeks after the second dose of mRNA-1273 vaccine administration the patient experienced non painful spot like chickenpox lesion in his chest and stomach. 4 months later, patient started experiencing heartburn pain and a rash on his wrist. Patient had his unspecified studies done which revealed high unspecified hepatic enzyme values. On unknown date, after the second dose of mRNA-1273 vaccine administration patient had liver discomfort, pain in the liver, fatty liver and also he has liver failure and does not process stomach acids and at the time of the report his symptoms had worsened. The medical history of unspecified hereditary problems with glucose remain confounder for the events hepatic failure and hepatic steatosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-551786 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 39-year-old, male patient with relevant medical history of unspecified hereditary problems with glucose, who experienced the unexpected serious (medically significant) AESI event of hepatic failure and unexpected serious (medically significant) event of hepatic steatosis. The events exact occurrence was unknown but stated that the events occurred after the second dose of mRNA-1273 vaccine administration. Allegedly the events were described as, 2 weeks after the second dose of mRNA-1273 vaccine administration the patient experienced non painful spot like chickenpox lesion in his chest and stomach. 4 months later, patient started experiencing heartburn pain and a rash on his wrist. Patient had his unspecified studies done which revealed high unspecified hepatic enzyme values. On unknown date, after the second dose of mRNA-1273 vaccine administration patient had liver discomfort, pain in the liver, fatty liver and also he has liver failure and does not process stomach acids and at the time of the report his symptoms had worsened. The medical history of unspecified hereditary problems with glucose remain confounder for the events hepatic failure and hepatic steatosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.