Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic failure, Portal vein thrombosis
Clinical narrative: liver failure; developed a clot in her portal vein; This spontaneous case was reported by a consumer and describes the occurrence of PORTAL VEIN THROMBOSIS (developed a clot in her portal vein) and HEPATIC FAILURE (liver failure) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PORTAL VEIN THROMBOSIS (developed a clot in her portal vein) (seriousness criteria death, hospitalization and medically significant) and HEPATIC FAILURE (liver failure) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Liver failure. It is unknown if an autopsy was performed.            It was reported that the reporter believed that her mother passed away as a result of a complication with the vaccine. Patient's mother received first dose on 28-JAN-2021. Patient received second dose one 26-FEB-2021. The patient was 85-year-old with hypertension and diabetes and developed a clot in her portal vein. Patient was hospitalized. The clot made her go into liver failure which was the cause of death. The date of the reported events remained unknown at the time of the report.    Treatment information were not provided by the reporter.  Concomitant medications were not reported by reporter.  Company Comment: This is the case of an 85-year-old female subject with a history of hypetension and diabetes who died due to hepatic falure. Reportedly, the patient initially developed thrombosis in portal vein (a clot in her portal vein), however a temporal association between the use of the product and the start date of the event was not reported. The patient subsequently developed liver failure and died due to liver failure, as reported, however, the date of death was not provided. It is unknown if an autopsy was performed. Very limited information regarding these events has been provided at this time. Causality is confounded with the patient's advanced age, hypertension and diabetes.; Sender's Comments: This is the case of an 85-year-old female subject with a history of hypetension and diabetes who died due to hepatic falure. Reportedly, the patient initially developed thrombosis in portal vein (a clot in her portal vein), however a temporal association between the use of the product and the start date of the event was not reported. The patient subsequently developed liver failure and died due to liver failure, as reported, however, the date of death was not provided. It is unknown if an autopsy was performed. Very limited information regarding these events has been provided at this time. Causality is confounded with the patient's advanced age, hypertension and diabetes.; Reported Cause(s) of Death: Liver failure