Your Health. Your Family. Your Choice.
Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: died at home; This is a spontaneous report from a contactable other hcp. A 67-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/Lot Number: EK4240), via an unspecified route of administration as single dose on an unspecified date (at 67-year-old) for COVID-19 immunisation. Medical history included ongoing amyotrophic lateral sclerosis (ALS). There was no information on heart disease. The patient''s concomitant medications were not reported. The patient experienced died at home on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2020517122 master case; 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