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Administered by: Other Purchased by: ?
Life Threatening? Yes
Write-up: Sudden death; changes to breathing; The initial case was missing the following minimum criteria: no first-hand knowledge. Upon receipt of follow-up information on 20Jan2021, this case now contains all required information to be considered valid. This case was received via e-reporting system by Program and received from a contactable other healthcare profession (HCP, a healthcare worker) downloaded from the Medicines Agency (MA) Regulatory Authority IS-IMA-1540. A 90-year-old male patient received bnt162b2 (COMIRNATY, lot number: EJ6796, expiration date: 30Apr2021) on 30Dec2020 at 0.3ml single for Covid-19 immunisation. Medical history and concomitant medication were not reported. On 06Jan2021 the patient was sleeping in his wheelchair when the staff at the nursing home noticed sudden changes to his breathing. The patient took few breaths with a long interval before he passed away. Sudden death reported as cause of death. It was unknown if autopsy was done. Reporter comment: The patients family considers whether the immunisation had a role in the patients death.; Sender''s Comments: Based on the available information, the Company considers a possible contributory role ofBNT162B2 vaccination in the development of sudden death and respiration abnormal in this elderly patient cannot be excluded. Additional information regarding relevant medical history, underlying conditions and concomitant medications will aid in comprehensive assessment of the case. 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: Sudden death
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