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Life Threatening? No
Write-up: Death; Acute dyspnea; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 18-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death), DYSPNOEA (Acute dyspnea) and PYREXIA (Fever) in a 90-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Syncope (recurrent syncope), Haemorrhage subarachnoid (status post traumatic subarachnoid haemorrhage) in 2019 and Aortic valve replacement. Concurrent medical conditions included Cardiac insufficiency, Cardiomyopathy (hypertensive, valvular and arrhythmogenic cardiopathy), Arterial hypertension, Aspiration pneumonia and Chronic renal insufficiency. On 12-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced DYSPNOEA (Acute dyspnea) (seriousness criterion death) and PYREXIA (Fever) (seriousness criterion death). The patient died on 06-Feb-2021. 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 04-Feb-2021, Body temperature: 38 ?C (High) 38?C. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered PYREXIA (Fever) to be possibly related and DEATH (Death) and DYSPNOEA (Acute dyspnea) to be unlikely related. Reporter did not allow further contact; Sender''s Comments: Based on reporter''s causality and patient''s advanced age along with multisystem underlying conditions, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Unknown cause of death
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