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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||UNKNOWN / 1||- / -|
Administered by: Other Purchased by: ??
Symptoms: Pyrexia, Septic shock, Polymerase chain reaction
Life Threatening? No
Birth Defect? No
Permanent Disability? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? Yes
Hospitalized? Yes, days: 2
Write-up: Pyrexia; Septic shock; This is a spontaneous report from a contactable physician. The patient was a 93-years-old (at the vaccination) female patient. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medical history. The patient''s concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. On 02May2021 (the day of vaccination), the patient received?the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: unknown, expiry date: unknown) via an unspecified route of administration for COVID-19 immunization in a hospital. On 03May2021 (one day after vaccination), the patient experienced pyrexia. On 15May2021 (13 days after vaccination), the patient died due to septic shock. An autopsy was not performed. The event pyrexia resulted in hospitalization (Emergency room/department or urgent care), disability and fatal. The duration of hospitalization was 2 days. The treatment received for the adverse event included antibacterial agents, infusions, vasopressors, oxygen administration, etc. On 15May2021, the patient has been tested for COVID-19 by polymerase chain reaction (PCR) test (Nasal Swab) and the test result was negative. An autopsy was not performed. The clinical outcome of septic shock and pyrexia was reported as fatal.; Sender''s Comments: Based on the available information and known product profile, the causal relationship between the reported events pyrexia and septic shock with a fatal outcome and the use of BNT162B2 seems unlikely. There is limited information available in this case to make a more meaningful assessment. The case will be assessed further upon receipt of additional information. 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: pyrexia; Septic shock
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