Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Severe COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (Severe COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   The patient's past medical history included Liver transplant (Time since liver transplant was reported less than one year). Concomitant products included SIROLIMUS and MYCOPHENOLATE MOFETIL for Immunosuppression.    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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Severe COVID-19) (seriousness criteria death and hospitalization). The patient was treated with Surgery (Invasive ventilation) for COVID-19. The cause of death was not reported. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) laboratory confirmed COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (Severe COVID-19) to be related.    Patient age was 60-69 years old.  No treatment medication were reported.  Company comment. This is a fatal literature non-study case concerning a male patient in the range of 60 to 69 years of age, with medical history of liver transplant, who experienced the unexpected, serious AESI of COVID - 19. The event occurred approximately one to two weeks after the administration of a dose of mRNA-1273 vaccine, reported as first dose of his COVID  19 immunization schedules. The report stated that the patient was in immunosuppression treatment with sirolimus and mycophenolate mofetil. The patient was admitted to an intensive care unit and required mechanical ventilation but died on an unspecified date. Patient´s cause of death was not further detailed, and it is unknown if autopsy was performed. Patient´s age and the medical history of liver transplant under concurrent immunosuppression treatment, could be a confounding factor for serious illness from COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-551355, MOD-2022-551368, MOD-2022-551369, MOD-2022-553577.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Follow up received by safety on 28-Apr-2022 has email with abstract received from team and contains significant information: Literature information, author details, reporter address, medical history and concomitant drug were updated.; Sender's Comments: This is a fatal literature non-study case concerning a male patient in the range of 60 to 69 years of age, with medical history of liver transplant, who experienced the unexpected, serious AESI of COVID - 19. The event occurred approximately one to two weeks after the administration of a dose of mRNA-1273 vaccine, reported as first dose of his COVID  19 immunization schedules. The report stated that the patient was in immunosuppression treatment with sirolimus and mycophenolate mofetil. The patient was admitted to an intensive care unit and required mechanical ventilation but died on an unspecified date. Patient´s cause of death was not further detailed, and it is unknown if autopsy was performed. Patient´s age and the medical history of liver transplant under concurrent immunosuppression treatment, could be a confounding factor for serious illness from COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death