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Life Threatening? No
Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB manufacturer report number ES-AEMPS-784368. A 51-year-old male patient received bnt162b2 (COMIRNATY), dose 1 at age of 51-year-old via unspecified route on 24Feb2021 (Lot Number: EP9598) at 0.3 mL, single for covid-19 immunization. Medical history included non-bulbar amyotrophic lateral sclerosis from 2015, under outpatient follow-up, no baseline respiratory involvement or need for non-invasive mechanical ventilation, peripheral muscle involvement. The patient''s concomitant medications were not reported. First dose of bnt162b2 vaccine was administered on 24Feb2021 and 4 hours later, coinciding after dinner, he presented with sudden dyspnoea, with subsequent vomiting, general malaise and decreased level of consciousness. Emergency medical services found desaturation of 80%, respiratory work, no skin alterations. Oxygen and hydrocortisone were administered and he was transferred to hospital emergency. On arrival at the emergency department with low level of consciousness and desaturation. Blood gases showed severe hypercapnic respiratory failure (not present at baseline). Resuscitation and non-invasive ventilation were attempted (patient with a therapeutic ceiling for the underlying disease and the patient''s wishes) and the patient finally succumbed. A causal relationship secondary to vaccine anaphylaxis cannot be ruled out. additional information: Vaccine LOT: EP9598. Tryptase test has not been performed. Patient dependent for all activities of daily living due to muscular deficit, but with no history of dysphagia, bronchial aspiration or dyspnoea. He was not a user of mechanical ventilation. The patient died on 24Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: Acute Respiratory failure; Depressed level of consciousness; sudden dyspnoea; vomiting; general malaise; desaturation of 80%; secondary to vaccine anaphylaxis.
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