Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19
Clinical narrative: acute hypoxic respiratory failure; COVID-19; This literature-study case was reported in a literature article and describes the occurrence of ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) and COVID-19 (COVID-19) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       The patient's past medical history included Chronic kidney disease and Lymphoma. Concurrent medical conditions included Hypertension and Waldenstrom's macroglobulinaemia.    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 COVID-19 (COVID-19) (seriousness criteria death and hospitalization). The reported cause of death was Acute hypoxic respiratory failure and covid-19. 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 COVID-19 (COVID-19) to be possibly related.    Concomitant product and treatment medication use was not provided by the reporter.  Company Comment: This literature-study case concerns a 75-year-old male patient with relevant medical history of chronic kidney disease and lymphoma, and concurrent medical conditions of hypertension and Waldenstrom macroglobulinemia, who experienced serious unexpected events of special interest (AESI) acute respiratory failure and COVID-19. The events occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable due to nature of the event and as no information regarding number of doses administered, no rechallenge was done and thus, recurrence was not applicable . The patient passed away due to the events. It was not reported whether autopsy was performed. Patient's medical history and concurrent condition may had contributed to development of the reported events and to the fatal outcome. The benefit-risk relationship of product is not affected by this report   This case was linked to MOD-2021-371501, MOD-2021-371537, MOD-2021-371539, 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 a regulatory authority and  contains significant information. Added correspondence contact in general tab; medical relevant history in patient tab; Sender's Comments: This literature-study case concerns a 75-year-old male patient with relevant medical history of chronic kidney disease and lymphoma, and concurrent medical conditions of hypertension and Waldenstrom macroglobulinemia, who experienced serious unexpected events of special interest (AESI) acute respiratory failure and COVID-19. The events occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable due to nature of the event and as no information regarding number of doses administered, no rechallenge was done and thus, recurrence was not applicable . The patient passed away due to the events. It was not reported whether autopsy was performed. Patient's medical history and concurrent condition may had contributed to development of the reported events and to the fatal outcome. The benefit-risk relationship of product is not affected by this report; Reported Cause(s) of Death: acute hypoxic respiratory failure; COVID-19