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Life Threatening? No
Write-up: Oxygen saturation decreased; This is a spontaneous report from a contactable physician from The Regulatory Authority-WEB, Regulatory Authority number is FR-AFSSAPS-RE20210558. An 83-year-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, lot number: EJ6788, expiry date was not reported), intramuscular in the left arm on 12Feb2021 at a single dose for COVID-19 immunisation. Medical history included hypertension arterial, chronic leg wounds, Alzheimer''s disease, and arteriopathy of the lower limbs, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Historical vaccine included COMIRNATY, first dose, intramuscular injection (batch number unknown) on an unknown date for COVID-19 immunisation. Patient was considered to be at risk of developing a severe form of COVID-19 disease, not having contracted COVID-19. The patient experienced oxygen saturation decreased on 15Feb2021 with fatal outcome. The patient died on 18Feb2021. It was not reported if an autopsy was performed. It was mentioned that on 15Feb2021 a test (unknown) was carried out, awaiting the result. It was mentioned that during the night of 15Feb2021 to 16Feb2021, the patient presented with desaturation requiring oxygenation. On 16Feb2021: Improvement of the patient''s condition allowing oxygen weaning. General condition deteriorating in a very inconstant way (Feb2021), unknown outcome. 18Feb2021 at 11:00 p.m .: Death of the patient. Evolution: Death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Oxygen saturation decreased
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