Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Autoimmune disorder, Hepatic enzyme, Hepatic enzyme increased, Thrombosis
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (blood clot in the left leg), AUTOIMMUNE DISORDER (Autoimmune diseased) and HEPATIC ENZYME INCREASED (Raised liver enzymes) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced THROMBOSIS (blood clot in the left leg) (seriousness criterion medically significant). In August 2021, the patient experienced AUTOIMMUNE DISORDER (Autoimmune diseased) (seriousness criterion medically significant). On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (Raised liver enzymes) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency and PREDNISONE for Hepatic enzyme increased, at an unspecified dose and frequency. In July 2021, HEPATIC ENZYME INCREASED (Raised liver enzymes) had resolved. At the time of the report, THROMBOSIS (blood clot in the left leg) and AUTOIMMUNE DISORDER (Autoimmune diseased) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Alanine aminotransferase increased: 1400. On an unknown date, Hepatic enzyme: raising liver enzyme numbers. Patient did not have any previous health conditions before getting the vaccine. Patient was not on any medications before the vaccine. No concomitant medications was reported. After vaccination 3 weeks following patient got a blood clot in the left leg. From that hospital visit until July, they had raising liver enzyme numbers which ended in July2021. Patient was on Eliquis now and was put on Prednisone to lower the liver enzyme numbers but was not currently on that. Patient was taking natural supplements. Company comment: This is a spontaneous case concerning a 88-year-old male patient with no previous health condition, who experienced the serious (medically significant) unexpected events thrombosis leg, hepatic enzymes increased and autoimmune disorder. Three weeks after  the second dose of mRNA-1273, patient visited hospital due to left leg thrombosis. After that, experienced raising liver enzymes with ALT result 1400. Six months after vaccination, was diagnosed with an autoimmune disease. Patient was treated with apixaban and prednisone. Further information has been requested. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: Company comment: This is a spontaneous case concerning a 88-year-old male patient with no previous health condition, who experienced the serious (medically significant) unexpected events thrombosis leg, hepatic enzymes increased and autoimmune disorder. Three weeks after  the second dose of mRNA-1273, patient visited hospital due to left leg thrombosis. After that, experienced raising liver enzymes with ALT result 1400. Six months after vaccination, was diagnosed with an autoimmune disease. Patient was treated with apixaban and prednisone. Further information has been requested. The benefit-risk relationship of mRNA-1273 is not affected by this report.