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Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: ACUTELY SHORT OF BREATH; APPEARED TO DEVELOP ACUTE RESPIRATORY DISTRESS; This is a report received from Health Products Regulatory Agency Regulatory authority report number IE-HPRA-2021-068085 with Safety Report Unique Identifier IE-HPRA-2021-068085. A 98-year-old male patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: ER0641) at a single dose for COVID-19 immunisation. The patient was reportedly living in a residential institution and was on grade 2 fluids and minced diet. Medical history included atrial fibrillation, dementia, Cognitive impairment, asthenia, respiratory symptom (it was outlined that the patient tended to be chesty without any formal lung diagnosis), hypothyroidism, gastritis, insomnia, and agitation; all from an unknown date and unknown if ongoing. The patient previously took the first dose of BNT162B2 (COMIRNATY) vaccine on 19Jan2021 (Lot number: EM4077) for COVID-19 immunisation. Concomitant medications included quetiapine taken for agitation; acetylsalicylic acid (NU-SEALS) taken for atrial fibrillation; pantoprazole taken for gastritis; zopiclone taken for insomnia; and levothyroxine sodium (ELTROXIN) taken for an unspecified indication. The patient experienced acutely short of breath and appeared to develop acute respiratory distress on 18Feb2021. The seriousness criteria of the events were death and outcomes of the events were fatal. The patient was transferred to hospital via ambulance and died within an hour of arrival on an unspecified date in Feb2021. It was not reported if an autopsy was performed and the reported causes of death were shortness of breath and respiratory distress. Reportedly, the coroner was informed. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Shortness of breath; Respiratory distress
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