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Life Threatening? No
Write-up: Cardiac arrest; The initial case was missing the following minimum criteria: first-hand knowledge of the event. Upon receipt of follow-up information on 28Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer, with follow-up from a nurse (colleague of the patient). A 53-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscularly in Feb2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. It was unknown if the patient had been tested for COVID-19 since the vaccination. It was unknown if the patient received any other vaccine within four weeks of the suspect vaccine. It was unknown if the patient was diagnosed with COVID prior to vaccination. The patient''s medical history included hypertension from an unknown date and unknown if ongoing. It was unknown if the patient had allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (COMIRNATY) for COVID-19 immunization on an unknown date in Jan2021 (intramuscularly; (Batch/Lot Number: Unknown).On 08Feb2021, the patient experienced cardiac arrest, which was assessed as medically significant and resulted in death. It was unknown if treatment was received for the cardiac arrest. It was initially reported that the reporter mentioned that she was talking to someone casually. That person said to the reporter that she knew someone, who was a nurse, in the age group 50-60, and was vaccinated with the second dose of the Pfizer COVID vaccine, and some days later died. The patient died on an unspecified date in 2021 due to cardiac arrest. An autopsy was not performed. Follow-up attempts have been completed and no further information is expected.; Sender''s Comments: Limited information precludes a medically meaningful assessment of the case. Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Cardiac arrest cannot be totally excluded. The case will be reassessed if 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: Cardiac arrest
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