Adverse Event Reporting
| VAERS ID | 1576765 |
|---|---|
| Gender | Male |
| Age | 71 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | 2 |
| Vaccinated | 2021-06-15 |
| Onset | 2021-06-16 |
| Condition | Hospitalized Died |
Symptoms
- Pyrexia
- Vomiting
- Body temperature
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Lung cancer; Metastases to brain
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20210616; Test Name: pyrexia; Result Unstructured Data: Test Result: 38 Centigrade.
Write-up
Pyrexia of 38 degrees Celsius; Vomiting; This is a spontaneous report from a contactable physician received from the Regulatory Authority.
Regulatory authority report number is v21122114.
The patient was a 71-year and 6-month-old male.
Body temperature before vaccination was not provided.
The family history was not provided.
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).
Medical history included lung cancer and metastases to brain.
On unknown date in 2021, the patient previously received the first dose of COVID-19 vaccine (Lot# unknown, Expiration date unknown).
On 15Jun2021 (the day of vaccination), the patient received the second dose of COVID-19 vaccine (Lot number unknown, Expiration date unknown) via an unspecified route of administration as dose 2, single (at the age of 71 years old) for COVID-19 immunization.
On 16Jun2021 (one day after the vaccination), the patient experienced pyrexia of 38 degrees Celsius and vomiting.
On 28Jun2021 (13 days after the vaccination), the outcome of the event was fatal.
The course of the event was as follows: Until 15Jun2021 (the day of vaccination), the patient had no pyrexia.
The patient received the second dose of COVID-19 vaccine.
On 16Jun2021 (one day after vaccination), in the morning, the patient experienced pyrexia of 38 degrees Celsius.
At noon, when nutrition was administered via the gastrostomy tube, the patient experienced vomiting.
The reporting physician classified the event as serious (death).
The causality between the event and COVID-19 vaccine was not provided.
Other possible causes of the event such as any other diseases were lung cancer and metastases to brain.
The reporting physician commented as follows: Since the patient was bedridden for lung cancer and metastases to brain, it was considered unlikely that the patient died due to the vaccination.
Although the pyrexia was improving during the hospital course, the pathological condition suddenly changed, and the patient died on 28Jun2021.
It was unknown if autopsy was performed.
Pfizer is a marketing authorization holder of COVID-19 vaccine in the country of incidence or the country where the product was purchased (if different).
This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities.
Information on the lot/batch number has been requested.
; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events fever and vomiting (fatal) and suspect drug BNT162B2 cannot be established.
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 of 38 degrees Celsius; vomiting