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Life Threatening? No
Write-up: COVID-19; general deterioration in her health status; Drug ineffective; This is a spontaneous report from contactable consumers and nurse via other company. A 53-year-old female patient received bnt162b2 (Formulation: Solution for injection), via an unspecified route of administration on an unknown date in Jan2021 at single dose for COVID-19 immunisation. Medical history included endotracheal intubation and ongoing mechanical ventilation. Concomitant medication included macitentan (OPSUMIT) at 10mg once a day for pulmonary arterial hypertension, selexipag (UPTRAVI, Strength: 800 ug) at 800 ug, twice a day for pulmonary arterial hypertension. It was reported that patient was vaccinated with the first dose of COVID-19 vaccine and one week after that began general deterioration in her health status on an unknown date in Jan2021. The patient was hospitalised and diagnosed with COVID-19 on 29Jan2021 and shortly after that had severe dyspnea on an unknown date in Jan2021. The patient was intubated and sedated on MV(mechanical ventilation). It was reported that patient was hospitalized since 29Jan2021 until death. The patient died on 04Feb2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender''s Comments: Based on the temporal relationship, the association between the event lack of effect (fatal COVID19) with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: general deterioration in her health status; COVID-19; severe dyspnea
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