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Life Threatening? No
Write-up: Circulatory failure/circulatory arrest; chest pain; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB and received via Regulatory Authority SE-MPA-2021-001718. Other case identifier number SE-MPA-1611673292424. A 61-years-old female patient received bnt162b2 (COMIRNATY), lot number: EL1484, intramuscular in Jan2021 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was reported three days after vaccination in 2021, the patient suddenly experienced chest pain. Fell down and Circulatory failure/circulatory arrest. The patient died after one hour with cardiopulmonary rescue. Reporter wrote no clinical suspicion of correlation with vaccination. The report was reported as serious with death. Autopsy was ordered by reporter. The Medical Products Agency had requested for autopsy protocols and epicrisis. The patient died of Circulatory failure/circulatory arrest on an unspecified date in 2021. The outcome of events chest pain and fell down was unknown. It was not reported if an autopsy was performed at the time of report.; Sender''s Comments: Based on temporal association, the causal relationship between bnt162b2 and the events circulatory collapse and chest pain cannot be excluded. The contributory role of the pre-existing COPD and hypertension cannot be excluded as well. It is noted that an autopsy has been requested. This case will be reassessed once additional information becomes available. 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: Circulatory failure/circulatory arrest
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