Your Health. Your Family. Your Choice.
Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: The patient died; Loss of appetite; Physical deterioration; Lethargy; Weakness; Chills; This is a spontaneous report from a non-contactable consumer, downloaded from the Agency Regulatory Agency-WEB (regulatory authority number DE-PEI-CADR2021014865). An 86-year-old female patient received a single dose of BNT162b2 (COMIRNATY), intramuscular, on 28Dec2020, for COVID-19 immunisation. The patient''s medical history included ongoing vascular dementia. The patient''s concomitant medications were not reported. On 03Jan2021, the patient experienced weakness, chills, and lethargy, all reported as non-serious events. On an unspecified date the patient died. The date of death and cause of death were not provided. It was unknown if an autopsy was performed. The outcome of the events weakness, chills, and lethargy was unknown. The causality for the events increasing weakness and chills was assessed as "A. Consistent causal association to immunization" and for death and lethargy as "C. Inconsistent causal association to immunization" Sender''s comment: Known vascular dementia (early stage)/ increasing weakness, loss of appetite, physical deterioration. No follow-up attempts needed, follow-up automatically provided .; Sender''s Comments: Based on the information currently available a causal relationship between event death of unknown causa and BNT162b2 (COMIRNATY) vaccine can be excluded. This 86 year-old patient death is attributed to underlying medical conditions including ongoing vascular dementia. 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: Unknown cause of death
Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166