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Write-up: COVID-19 aggravated; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-NC20211060. An 80-year-old female patient received her first dose of BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), via intramuscular route in the arm on 25Feb2021 as a single dose for COVID-19 immunisation. Medical history included cardiac decompensation, and hypertension in July 2019, obesity, calcified aortic valve, and DTE carotid atheroma (55%). Concomitant medications included hydrochlorothiazide (ESIDREX), ginkgo biloba (TANAKAN), losartan potassium (COZAAR), atenolol, and furosemide. Since 27Feb2021, the patient has presented chills, cough, dyspnea-orthopnea, two episodes of vomiting, loss of appetite, two coughing up blood (one red and one black). Cardiology consultation recently does not mention his calcified aortic stenosis in the report of 26Nov. The patient tested positive for COVID-19 (variant) on 01Mar2021 while going to the emergency room and then returned home. The patient consulted again on 02Mar2021 because his condition deteriorated during the day. Acidosis and hypercapnia were corrected by non-invasive ventilation. The next day, patient had respiratory deterioration. On 03Mar2021, the patient was referred by his doctor in emergency. On 03 Mar2021, PH was 7.17 and PCO2 was 87. Patient was put under non-invasive ventilation. Initial clinical examination showed "Sym and bilateral vesicular murmur, bilateral crackles, irregular heart noise, calcified aortic stenosis murmur, edema of the lower limbs, soft and painless abdo, confused glasgow scale GSC 14." CARDIO ADVICE: decompensation which seems to be more due to COVID than to acute lung edema. CAR BNP (Btype natriuretic peptide) very high. Summary of management and evolution: Respiratory decompensation on COVID and acute lung edema (for cardio). Effectiveness of the non-invasive ventilation following a session of one more hour, control gas PH 7.344, PCO2 52. Patient was still confused after refusal of care. Serious opinion was made, comfort care. During the first week of hospitalization, patient was relatively stationary. However, there was clear deterioration of the disease in the second week of hospitalization. Unfavorable changes with the death on 15Mar2021. It was not reported if an autopsy was performed. Conclusion: Covid-19 possibly aggravated by vaccination. Indeed, all her family circle has tested positive for COVID19 (variant): woman (57 years old, co-morbidities with cancer right cardiac decompensation, COPD(Chronic obstructive pulmonary disease), neurodegenerative disease) and the young girl (24 years old). They did not benefit from the vaccination and remained asymptomatic, except for the patient. This obviously remains a hypothesis. The pharmacovigilant notes: Accountability score(s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Covid-19 aggravated
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