Adverse Event Reporting
| VAERS ID | 1435422 |
|---|---|
| Gender | Female |
| Age | 92 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EY5420 |
| Number of vaccinations | 2 |
| Vaccinated | 2021-06-15 |
| Onset | 2021-06-17 |
| Condition | Died |
Symptoms
- Malaise
- Unresponsive to stimuli
- Respiratory arrest
- Blood pressure decreased
- Oxygen saturation decreased
- Cyanosis
- Hypopnoea
- Blood pressure measurement
- Body temperature
- Cardiac arrest
- Depressed level of consciousness
- Oxygen saturation
- Cardiac failure acute
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Cardiac failure chronic (since about 8 months earlier); Pleural effusion (since about 8 months earlier)
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20210617; Test Name: Blood pressure; Result Unstructured Da1ta: Test Result:immeasurable; Test Date: 20210615; Test Name: Body temperature; Result Unstructured Data: Test Result:37.
1 Centigrade; Comments: before vaccination; Test Date: 20210617; Test Name: SPO2 level; Result Unstructured Data: Test Result:was 72% for a moment; Comments: but immediately became immeasurable
Write-up
Respiratory arrest; Cardiac arrest; blood measurement was immeasurable; The respiratory was shallow and weak; Cyanosis of lip; Marked malaise; Depressed level of consciousness; Unresponsive to calls; The SpO2 level was 72% for a moment but immediately became immeasurable; Cardiac failure acute; This is a spontaneous report from a contactable physician received from the Agency.
Regulatory authority report number is v21115279.
The patient was a 92-year and 7-month-old female.
Body temperature before vaccination was 37.
1 degrees Celsius.
Medical history included cardiac failure chronic and accumulated pleural effusion since about 8 months earlier.
Family history and concomitant medications were not reported.
There were no particular 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 25May2021 (the day of the first vaccination), the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported) for COVID-19 immunisation.
On 15Jun2021 at 14:00 (the day of the second vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation.
On 17Jun2021 at 18:05 (2 days after the second vaccination), the patient experienced marked malaise, depressed level of consciousness, cyanosis of lip, "was unresponsive to calls", and "the SpO2 level was 72% for a moment but immediately became immeasurable".
On 17Jun2021 at 18:10 (2 days after the second vaccination), the respiratory was shallow and weak, and blood measurement was immeasurable.
On 17Jun2021 at 18:18 (2 days after the second vaccination), the patient experienced respiratory arrest and cardiac arrest, and died.
The cause of death was reported as cardiac failure acute.
It was not reported whether autopsy was done.
The outcome was reported as fatal.
The course of the events was as follows: On 25May2021 (the day of the first vaccination), the patient received the first vaccination and had uneventful course.
On 15Jun2021 (the day of the second vaccination), the patient received the second vaccination and had experienced nothing such as pyrexia.
On 17Jun2021 at 18:05 (2 days after the second vaccination), the patient started to have marked malaise at the midpoint of dinner.
She chocked when drinking tea by herself.
She seemed at her limit after eating one-ninth amount of the meal.
During observation of her condition, the patient had depressed level of consciousness, developed cyanosis of lip, and was unresponsive to calls.
Suctioning of sputum was done, but only a small volume was aspirated.
The SpO2 level was 72% for a moment but immediately became immeasurable.
At 18:10, the respiratory was shallow and weak, and blood measurement was immeasurable.
At 18:18, respiratory arrest and cardiac arrest developed, and death was confirmed.
Seriousness was reported as serious (death).
The physician assessed the causality between the events and BNT162b2 as unassessable.
Other possible cause(s) of the events such as any other diseases were reported as cardiac failure chronic and accumulated pleural effusion.
The reporting physician commented as follows: Cardiac failure chronic and accumulated pleural effusion had been present since about 8 months earlier, and cardiac failure acute was considered as cause of death.
The causality with the vaccination was unknown.
; Reported Cause(s) of Death: Cardiac failure acute