Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Sepsis
Clinical narrative: acute hypoxic respiratory failure; Sepsis; This literature-study case was reported in a literature article and describes the occurrence of ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) and SEPSIS (Sepsis) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Characteristics and outcomes of adverse events after COVID-19 vaccination. 2021;2:e12565     Concurrent medical conditions included Cerebrovascular accident, Type 2 diabetes mellitus and Obstructive sleep apnea syndrome.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) (seriousness criteria death, hospitalization and medically significant) and SEPSIS (Sepsis) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Acute hypoxic respiratory failure and Sepsis. It is unknown if an autopsy was performed. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) and SEPSIS (Sepsis) to be possibly related.    Concomitant medications were not provided Treatment medications were not reported  Company Comment: This case concerns a 79-year-old, male patient with a history of Cerebrovascular accident, Type 2 diabetes mellitus and Obstructive sleep apnea syndrome, who experienced the fatal unexpected serious events of ACUTE RESPIRATORY FAILURE (AESI) and SEPSIS. The events occurred at within 10 days after a dose of Moderna COVID-19 vaccine. The rechallenge was not applicable due to the nature of the events. The medical history of Cerebrovascular accident, Type 2 diabetes mellitus and Obstructive sleep apnea syndrome remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-371501, MOD-2021-371537, MOD-2021-371538, MOD-2021-371540, MOD-2021-371541, MOD-2021-371542, MOD-2021-371543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety 03-Nov-2021 included an Email with FTA received from the team and  contains significant information.; Sender's Comments: This case concerns a 79-year-old, male patient with a history of Cerebrovascular accident, Type 2 diabetes mellitus and Obstructive sleep apnea syndrome, who experienced the fatal unexpected serious events of ACUTE RESPIRATORY FAILURE (AESI) and SEPSIS. The events occurred at within 10 days after a dose of Moderna COVID-19 vaccine. The rechallenge was not applicable due to the nature of the events. The medical history of Cerebrovascular accident, Type 2 diabetes mellitus and Obstructive sleep apnea syndrome remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: acute hypoxic respiratory failure; Sepsis