Adverse Event Reporting
| VAERS ID | 1476910 |
|---|---|
| Gender | Male |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EY5420 |
| Number of vaccinations | 1 |
| Vaccinated | 2021-06-14 |
| Onset | 2021-06-14 |
| Condition | Died |
Symptoms
- X-ray
- Pneumonia
- Oxygen saturation
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Cardiac failure; Cerebral infarction; Diabetes mellitus; Myocardial infarction
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20210614; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased; Test Date: 20210614; Test Name: X-ray; Result Unstructured Data: Test Result:extensive infiltrative shadow
Write-up
Pneumonia; This is a spontaneous report from a contactable physician received via the Agency.
The patient was an elderly male.
The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Prior to vaccination, the patient was not diagnosed with COVID-19.
Other medical history included cardiac failure, myocardial infarction, diabetes mellitus and cerebral infarction.
On 14Jun2021 in the morning (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) intramuscular for COVID-19 immunization at a hospital.
On 14Jun2021 (the day of vaccination), the patient experienced pneumonia.
On 16Jun2021 (2 days after the vaccination), the patient died.
The outcome of the event was fatal with treatment including antibiotic.
The cause of death was pneumonia.
(The event resulted in death.
) An autopsy was not performed.
The course of the events was as follows: On 14Jun2021, after the vaccination, no abnormalities were noted.
At noon, tube feeding was performed, afterwards oxygen saturation decreased, and pyrexia was noted.
X-ray showed extensive infiltrative shadow and a diagnosis of pneumonia was made.
Antibiotic therapy was performed.
On 16Jun2021, the patient died.
Since the vaccination, the patient had not been tested for COVID-19.
; Sender's Comments: Based on the close temporal relationship, the association between the event fatal pneumonia with COMIRNATY use could not be fully excluded.
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: Pneumonia