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Life Threatening? Yes
Write-up: Distress respiratory; Interstitial pneumonitis; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority (RA), regulatory authority number FR-AFSSAPS-MA20211067. An 86-years-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), intramuscular on 10Mar2021 as single dose for covid-19 vaccination; and macrogol (TRANSIPEG), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included hypertension, diabetes, loose (unconstricted) aortic stenosis, ischaemic stroke with sequential haemiparesis, endarterectomy. The patient had no reported COVID history. Concomitant medications included nebivolol hydrochloride (TEMERIT), nicardipine hydrochloride (LOXEN L P), chlorphenamine maleate, paracetamol, phenylephrine hydrochloride (FLUDEX PE), acetylsalicylate lysine (KARDEGIC), pravastatin, esomeprazole magnesium (MESOPRAL), paracetamol (DAFALGAN), and amiodarone hydrochloride (CORDARONE); all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient was hospitalised on unspecified dates in 2021 with distress respiratory (also reported as acute hypoxaemic respiratory distress) and interstitial pneumonitis experienced on 15Mar2021 within days of a first vaccination with Comirnaty. The patient had the vaccine on 10Mar2021. No information between 10 and 15Mar2021, but no infectious contagion because the patient does not leave home. The events distress respiratory and interstitial pneumonitis were also reported as life-threatening. Clinical course was reported as follows: On 15Mar2021, the patient was admitted to hospital with haemoptysis, chest pain, vomiting and diarrhoea, plus oxygen dependence at 4 litres. He had a dry cough with dyspnoea for several days. The angioscanner did not find any pulmonary embolism or active bleeding. The examination was compatible with COVID pneumonia, but also with other pathologies, infectious or not. The 2 PCRs performed were negative (15Mar2021). Other lab tests on 15Mar2021 included: Creatinine 120 umol, urea 12 mmol, no ionic disorder, troponin 6700 without chest pain, Brain natriuretic peptide (BNP) 1000, polynuclear neutrophils (PNN) 17G. Electrocardiography (ECG): no frank ischaemic signs. Left Ventricular Ejection Fraction (LVEF) preserved on transthoracic echocardiogram (TEE). Antibiotic treatment was started with a bolus of corticosteroids. Rapidly unfavourable evolution, need for 15l of O2 for a 91% saturation (18Mar2021), then deterioration of the respiratory function and death on 18Mar2021. The action taken in response to the events for bnt162b2 and macrogol was not applicable. The patient died on 18Mar2021. The causes of death were distress respiratory and interstitial pneumonitis. It was unknown if an autopsy was performed. No follow-up attempts possible; information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: distress respiratory; interstitial pneumonitis
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