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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||EK4241 / 1||- / -|
Administered by: Other Purchased by: ??
Symptoms: Diabetic ketoacidosis
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
Hospitalized? Yes, days:
Write-up: Circumstances of death: was hospitalized on the background of DKA (Diabetic ketoacidosis); This is a spontaneous report from a contactable healthcare professional via the regulatory Authority. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EK4241) as a single dose for COVID-19 immunization. Medical history included hypertension, hyperlipidemia, diabetes mellitus, and CHF. The patient''s concomitant medications were not reported. Circumstances of death: was hospitalized on the background of DKA (Diabetic ketoacidosis). The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the current available information, the event Diabetic ketoacidosis is most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2. The case will be reassessed if additional information becomes available. 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: DKA (Diabetic ketoacidosis)
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