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Life Threatening? No
Write-up: condition deteriorated; fall; pertrochanteric fracture on the left side; Death/ heart attack contributed to her death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB HU-OGYI-394121. An 83-year-old female patient received second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), intramuscularly on 05May2021 as 0.3 ml single dose for covid-19 immunisation. Medical history included ischemic heart disease, atherosclerosis, chronic obstructive pulmonary disease (COPD) and hypostatic pneumonia. Concomitant drugs were not reported. The patient previously received first dose of bnt162b2 (Batch/Lot Number: Unknown) on unknown date as single dose for covid-19 immunisation. The patient was hospitalized on 14May2021 after a fall. Examinations showed a pertrochanteric fracture on the left side. The patient received surgery, but despite therapy, her condition deteriorated. The patient passed away on 16May2021 at 16:10. The outcome of events fall and pertrochanteric fracture was unknown. The patient died on 16May2021. An autopsy was performed but results were not provided. Sender Comment: As the patient was hospitalized because of a fall and then passed away due to her general condition in association with her primary diseases, the causal relationship is unlikely between the suspected drug and the adverse event. The patient also had a recent heart attack which also contributed to her death. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up Information on batch/lot number cannot be obtained attempts are possible. No further information expected.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the myocardial infarction and the other events. The reported events likely represent intercurrent medical conditions. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. 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: heart attack contributed to her death; condition deteriorated
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