Adverse Event Reporting
| VAERS ID | 2013591 |
|---|---|
| Gender | Female |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | FK9706 |
| Number of vaccinations | 3 |
| Vaccinated | 2021-12-13 |
| Onset | 2021-12-13 |
| Condition | Died |
Symptoms
- Immunisation
- Death
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Metastatic neoplasm (Widespread metastatic cancer in the palliative phase)
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
DEATH; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB.
Regulatory number: NO-NOMAADVRE-FHI-2021-Vqz8kb (RA).
Other Case identifier(s): NO-NOMAADVRE-E2B_00067077 (RA).
A 51 year-old female patient (unknown if pregnant) received BNT162b2 (COMIRNATY), intramuscular, administration date 13Dec2021 (Lot number: FK9706) as dose 3 (booster), single for COVID-19 immunisation.
Relevant medical history included: "metastatic cancer" (unspecified if ongoing), notes: Widespread metastatic cancer in the palliative phase.
Illness at vaccination included: "Stomach pain" (unspecified if ongoing), notes: Alternating stomach pain the last two weeks before vaccination and also after vaccination; "poor health condition" (unspecified if ongoing), notes: the patient was in a poor health condition for the last two weeks before being vaccinated with dose 3.
The patient's concomitant medications were not reported.
Vaccination history included: COVID-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; COVID-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation.
The patient had alternating stomach pain the last two weeks before vaccination and also after vaccination.
The pain was suspected to be due to liver metastases.
She was in a poor health condition for the last two weeks before being vaccinated with dose 3.
The vaccination did not worsen her health condition.
The patient wanted to take dose 3.
She was daily visited by her husband.
The following information was reported: DEATH (death) with onset 15Dec2021, outcome "fatal", described as "DEATH".
The reported cause of death was not reported.
It was not reported if an autopsy was performed.
Reporter's comments and additional relevant information: She was in a poor health condition for the last two weeks before being vaccinated with dose 3.
The vaccination did not worsen her health condition.
The patient wanted to take dose 3.
The Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible.
No follow-up attempts are possible.
No further information is expected.
; Reporter's Comments: 21DEC2021: additional information received.
The following fields have been updated: Patient (Disease), Event Desc.
Reporters comments and additional relevant information: She was in a poor health condition for the last two weeks before being vaccinated with dose 3.
The vaccination did not worsen her health condition.
The patient wanted to take dose 3.
; Reported Cause(s) of Death: Unknown cause of death