Age: 79.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Pneumonia, Positive airway pressure therapy, Pulmonary oedema, SARS-CoV-2 test negative, Vascular operation
Clinical narrative: Breathing issues  7-9 days after vaccination; Passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) and DYSPNOEA (Breathing issues  7-9 days after vaccination) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Oct-2022, the patient experienced DYSPNOEA (Breathing issues  7-9 days after vaccination) (seriousness criterion hospitalization). The patient died on 29-Oct-2022. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (Breathing issues  7-9 days after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2022, SARS-CoV-2 test: (Negative) COVID Test results came back and it was negative. On an unknown date, Chest X-ray: Chest X-Ray came back with ground glass.         No concomitant medications were reported. The patient received Moderna COVID-19 vaccine on 15-Oct-2022 or 16-Oct-2022. He was in isolation in the hospital until COVID Test results came back and it was negative. Caller did not have the vaccination card.  Treatment information was not provided.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a 79-year-old male patient with no medical history reported, who had a fatal outcome with unexpected serious event of Death, and was hospitalized due to the unexpected serious event of Respiration abnormal, which occurred on the same month of mRNA-1273.222 vaccination. Latency cannot be properly assessed since the exact vaccination date was not provided. It was reported that the patient had breathing issues 7 to 9 days after the vaccination and was hospitalized. Patient was in isolation in the hospital until  COVID-19 test results came back and it was negative. However, Chest X-Ray showed ground glass result. No further details about the treatments were provided. The clinical course leading to demise and the cause of death were not reported. It was unknown whether an autopsy was performed. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 79-year-old male patient with no medical history reported, who had a fatal outcome with unexpected serious event of Death, and was hospitalized due to the unexpected serious event of Respiration abnormal, which occurred on the same month of mRNA-1273.222 vaccination. Latency cannot be properly assessed since the exact vaccination date was not provided. It was reported that the patient had breathing issues 7 to 9 days after the vaccination and was hospitalized. Patient was in isolation in the hospital until  COVID-19 test results came back and it was negative. However, Chest X-Ray showed ground glass result. No further details about the treatments were provided. The clinical course leading to demise and the cause of death were not reported. It was unknown whether an autopsy was performed. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death