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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: Reported causes of death: Diarrhoea; This is a spontaneous report from a contactable healthcare professional via agency and a non-contactable consumer via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. An elderly patient of an unspecified age (also reported as were in their early to mid-60''s) and gender received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 10Dec2020 at a single dose for COVID-19 immunisation. Medical history included pseudomembranous colitis (broad), gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), and noninfectious diarrhoea (narrow) . The patient''s concomitant medications were not reported. The patient experienced diarrhoea on an unspecified date in 2020. It was reported that most of the deaths after the COVID-19 vaccine occurred within 24-48 hours after the shot. The write-ups that accompanied the reports furnished details about these sad fatalities, including the astonishing fact that some of the decreased had actually experienced and recovered from COVID-19 (raising questions about why they were vaccinated). It was also reported that the event was not life-threatening, did not result to a birth defect or permanent disability, did not require any office/ER/doctor visit, and did not require any hospitalization. The patient died on 10Dec2020. It was not reported if an autopsy was performed. The reported cause of death: diarrhoea. No follow up attempts are possible, information about the lot/batch number cannot be obtained.; Sender''s Comments: Based on the available information the event diarrhea resulting in death is attributed to patients preexisting medical conditions including pseudomembranous colitis, gastrointestinal nonspecific symptoms and therapeutic procedures, and noninfectious diarrhea. However, based on a close chronological association (same day) contributory role of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine) to event exacerbation cannot be completely excluded. 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: Reported causes of death: Diarrhoea
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