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Life Threatening? No
Write-up: Pneumonia aspiration; multi-organ failure; This is a spontaneous report from a non-contactable Health Professional received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 95-year-old female non-pregnant patient received bnt162b2 (COMIRNATY Solution for injection, Lot Number: Unknown) intramuscular on 22Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cardiac failure, renal failure chronic, hypertension, angina pectoris, dementia. It was unknown if the patient received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient''s concomitant medications were not reported. On 22Jun2021 (the day of vaccination), several hours after the vaccination, the patient had a meal. It was suspected that aspiration occurred afterwards. Pallor facial was noted, and SpO2 (oxygen saturation percutaneous) decreased to the 70% range. The patient was transferred to a hospital. At the time of hospitalization, her general condition was poor and she was in a state of multi-organ failure. On 24Jun2021, two days after the hospitalization, the patient died. The event resulted in hospitalization/death. The cause of death was pneumonia aspiration. An autopsy was not performed. The outcome of the events was fatal without treatment. The reporter stated that it was unknown if this was an adverse event, the possibility of the presence of an adverse event was fairly low. It was unknown if the patient has not been tested for COVID-19 since the vaccination.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on temporal association, a causal association between the reported events and BNT162B2 cannot be fully excluded. The patient''s advanced age has been assessed to have played a contributory role toward the events. 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 RAs, Ethics Committees, and investigators, as appropriate.; Reported Cause(s) of Death: multi-organ failure; Pneumonia aspiration
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