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Life Threatening? No
Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Agency Agency-WEB PL-URPL-3-367-2021. An 81-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EP9598; Expiration Date: 30Jun2021), intramuscular, administered in left arm on 18Feb2021 11:45 at a single dose for COVID-19 immunisation. Medical history included ongoing chronic extradural haematoma, ongoing arterial hypertension (hypertonia arterialis), and ongoing Type 2 diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced death on 07Mar2021 07:30, 3 weeks after vaccination of Comirnaty. The cause of death was unknown. It was unknown if an autopsy was performed. The reporter commented that death was not related to vaccination. Sender comments: In the submitted report, no post-vaccination symptoms preceding the patient death were described. Agency has only knowledge about comorbidities in the patient, i.e. arterial hypertension, non-insulin-dependent diabetes mellitus, chronic epidural hematoma. There is a time relationship between vaccine administration and death. Due to the above information, Agency assessed the reported death as occurring in a temporary coincidence with vaccination. The reporting doctor, in the description of the reaction, also did not link the death with the administration of the Comirnaty vaccine. The person reporting vaccine adverse event qualified it as severe. Due to the health result - death, Agency assessed the vaccine adverse event as severe. Death /WHO scale, Agency/ Unlikely. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Death not related to vaccination; Sender''s Comments: Event unknown cause of death is assessed as Related by the company until sufficient information is available to confirm an unrelated cause of death. 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: death
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