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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||FC3661 / 2||- / -|
Administered by: Other Purchased by: ??
Symptoms: Renal failure, Respiratory failure, Blood pressure measurement
Life Threatening? Yes
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: Respiratory failure; Renal failure; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21113660. The patient was a 96-year and 4-month-old female. Body temperature before vaccination was not reported. Family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported). On 01Jun2021 at around 13:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jun2021 at 15:00 (around 1 hour 30 minutes after the vaccination), the patient experienced respiratory failure and renal failure. On 02Jun2021 in the morning (1 day after the vaccination), the patient was admitted to the hospital. On 05Jun2021 (4 days after the vaccination), the outcome of the event was fatal. It was unknown if an autopsy was performed. The course of the event was as follows: On 01Jun2021 at around 13:30, the patient received the second dose of the vaccine. Just after 15:00, the patient had large amount of stools and blood pressure decreased to some extent, for which the patient received infusion. The patient ate supper as usual. At midnight, respiratory status aggravated and on 02Jun2021 in the morning, the patient was emergently admitted to a hospital. The patient was diagnosed with respiratory failure and renal failure and hospitalized. The patient received infusion and was placed on a ventilator; however, general condition gradually aggravated. On 05Jun2021, death was confirmed. The reporting physician classified the event as serious (life-threatening) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not provided. The reporting physician commented as follows: The patient was of advanced age and causality between the events and the vaccine was unknown.; Reported Cause(s) of Death: Respiratory failure; Renal failure
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