Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Septic shock
Clinical narrative: acute hypoxic respiratory failure; septic shock; This literature-study case was reported in a literature article and describes the occurrence of ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) and SEPTIC SHOCK (septic shock) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Concurrent medical conditions included Hypertension, Chronic obstructive lung disease, Graves' disease and Lung cancer.    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 SEPTIC SHOCK (septic shock) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Acute hypoxic respiratory failure and Septic shock. 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 SEPTIC SHOCK (septic shock) to be possibly related.    Concomitant product and treatment medication use was not provided by the reporter.  Company Comment: This case concerns a 76-year-old female patient, with medical history of hypertension, chronic obstructive pulmonary disease and lung cancer, who experienced the fatal events of ACUTE RESPIRATORY FAILURE and SEPTIC SHOCK. The events occurred on an unknown date after receiving an unknown dose number of the Moderna COVID 19 vaccine. The rechallenge is not applicable considering the outcome of the events. Patient's medical history of hypertension, chronic obstructive pulmonary disease and lung cancer remains as a confounder. The benefit-risk relation of the 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-2021-371539, 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 SARA team and  contains significant information. Added correspondence contact in general tab; medical relevant history in patient tab.; Sender's Comments: This case concerns a 76-year-old female patient, with medical history of hypertension, chronic obstructive pulmonary disease and lung cancer, who experienced the fatal events of ACUTE RESPIRATORY FAILURE and SEPTIC SHOCK. The events occurred on an unknown date after receiving an unknown dose number of the Moderna COVID 19 vaccine. The rechallenge is not applicable considering the outcome of the events. Patient's medical history of hypertension, chronic obstructive pulmonary disease and lung cancer remains as a confounder. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.; Reported Cause(s) of Death: acute hypoxic respiratory failure; Septic shock