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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||- / 1||- / OT|
|UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER||- / UNK||- / OT|
Administered by: Other Purchased by: ??
Symptoms: Sudden death, Vomiting, Blood pressure inadequately controlled
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
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidemia (under oral treatment NOS (ongoing)); Hypertension (under oral treatment NOS (ongoing)); Prostatic hypertrophy (under oral treatment NOS (ongoing))
Diagnostic Lab Data:
CDC 'Split Type': GRPFIZER INC2021059633
Write-up: sudden death; Vomiting; blood pressure unncotrolled; This is a spontaneous report from a contactable physician. An 87-year-old male patient received the first dose of BNT162B2 (COMIRNATY), intramuscular on 19Jan2021 as a single dose for COVID-19 immunisation. The patient also received FOLIFI which included irinotecan hcl (CAMPTO), calcium folinate (LEUCOVORIN), fluorouracil sodium (5 FLUROURACIL), aflibercept (MANUFACTURER UNKNOWN); all intravenous from 12Jan2021 to 13Jan2021 (at the hospital) at unknown doses cyclic for metastatic colorectal cancer. Medical history included hypertension, hyperlipidaemia, and prostatic hypertrophy. The patient''s concomitant medications included unspecified ongoing oral treatment for hypertension, hyperlipidaemia, and benign prostatic hyperplasia. In Jan2021, patient''s blood pressure was deregulated due to his chemotherapy the week prior and his hypertension treatment regimen was increased. The patient completed his chemotherapy regimen and returned home on 14Jan2021. On 19Jan2021, he was vaccinated with BNT162B2. In the morning of 20Jan2021, the patient experienced vomiting and recovered the same day. Then the patient got dressed. However, when he was going down the stairs, he experienced sudden death. He was transferred to the hospital, but he was already dead on 20Jan2021. No autopsy was performed as his family refused to permit it. The clinical outcome of blood pressure deregulated was unknown at the time of death. The actions taken in response to the events for irinotecan hcl, calcium folinate, fluorouracil sodium, and aflibercept were not applicable. The reporting physician considered that the chemotherapy and the vaccine were possibly related to the event of sudden death. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available, high age of the patient, and on the pathophysiology of the event company does not reasonably attribute the reported event as related to vaccine. The event was likely due to subject underlying contributory factors. Autopsy details would have been helpful for further medically meaningful causality assessment 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: sudden death
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