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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||EK4238 / 2||- / -|
Administered by: Other Purchased by: ??
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Current Illness: Dialysis; Renal insufficiency
Diagnostic Lab Data:
CDC 'Split Type': ILPFIZER INC2021330123
Write-up: collapsed at home; This is a spontaneous report from a contactable other healthcare professional via Agency Regulatory Authority. A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4238), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included ongoing dialysis patient and ongoing renal insufficiency both from an unknown date. It was unknown if the patient was pregnant at the time of vaccination. The patient''s concomitant medications were not reported. It was reported that the patient collapsed at home on an unspecified date. Emergency medical services performed, resuscitation. The outcome of collapsed at home was fatal. The patient died on an unspecified date. Cause of death was unknown. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. 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.,Linked Report(s) : IL-PFIZER INC-2020517122 same correspondence reporter, same product, other patient, other events (master case); Reported Cause(s) of Death: unknown cause of death
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