Adverse Event Reporting
| VAERS ID | 2032973 |
|---|---|
| Gender | Male |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | FC5435 |
| Number of vaccinations | 2 |
| Vaccinated | 2021-06-15 |
| Onset | 2021-12-20 |
| Condition | Died |
Symptoms
- SARS-CoV-2 test
- Computerised tomogram
- Pelvic pain
- COVID-19 pneumonia
- Body temperature
- Oxygen saturation
- Acute respiratory distress syndrome
- Vaccination failure
- PO2
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Aneurysm of abdominal aorta; GERD; Gout flare; Hypertension arterial; Ischaemic heart disease; Overweight; Stent placement; Type II diabetes mellitus
Other Medications
KARDEGIC; PLAVIX; DIAMICRON; FUROSEMIDE; INEGY; ISOPTINE; XELEVIA; PANTOPRAZOLE
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20211224; Test Name: body temperature; Result Unstructured Data: Test Result:39.
5 Centigrade; Test Date: 20211224; Test Name: computed tomography; Result Unstructured Data: Test Result:confirmed a coronavirus pneumopathy with an expand; Comments: confirmed a coronavirus pneumopathy with an expanded form around 20 to 30%; Test Date: 20211224; Test Name: saturation; Test Result: 86 %; Comments: on ambient air; Test Date: 20211224; Test Name: hypoxemia; Result Unstructured Data: Test Result:54 mmHg; Test Date: 20211222; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Delta variant
Write-up
major acute respiratory distress; Pelvic pain; Vaccination failure/Delta variant; COVID-19/Delta variant/coronavirus pneumopathy; This is a spontaneous report received from a contactable reporter(s) (Physician) from a regulatory authority.
Regulatory number: FR-AFSSAPS-TO202110025.
A 78 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15Jun2021 (Lot number: FC5435) as dose 2, single and administration date 07May2021 (Lot number: EX7389) as dose 1, single for covid-19 immunisation.
Relevant medical history included: "Overweight" (unspecified if ongoing); "Hypertension arterial" (unspecified if ongoing); "Type II diabetes mellitus" (unspecified if ongoing); "Aneurysm of abdominal aorta" (unspecified if ongoing); "Stent placement" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Ischaemic heart disease" (unspecified if ongoing); "Gout flare" (unspecified if ongoing).
Concomitant medication(s) included: KARDEGIC; PLAVIX; DIAMICRON; FUROSEMIDE; INEGY; ISOPTINE; XELEVIA; PANTOPRAZOLE.
The following information was reported: VACCINATION FAILURE (death, medically significant) with onset 20Dec2021, outcome "fatal", described as "Vaccination failure/Delta variant"; COVID-19 PNEUMONIA (death, medically significant) with onset 20Dec2021, outcome "fatal", described as "COVID-19/Delta variant/coronavirus pneumopathy"; ACUTE RESPIRATORY DISTRESS SYNDROME (death, medically significant) with onset 28Dec2021, outcome "fatal", described as "major acute respiratory distress"; PELVIC PAIN (death) with onset 24Dec2021, outcome "fatal", described as "Pelvic pain".
The events "vaccination failure/delta variant", "covid-19/delta variant/coronavirus pneumopathy ", "major acute respiratory distress" and "pelvic pain" were evaluated at the emergency room visit.
The patient underwent the following laboratory tests and procedures: body temperature: (24Dec2021) 39.
5 Centigrade; computerised tomogram: (24Dec2021) confirmed a coronavirus pneumopathy with an expand, notes: confirmed a coronavirus pneumopathy with an expanded form around 20 to 30%; oxygen saturation: (24Dec2021) 86 %, notes: on ambient air; po2: (24Dec2021) 54 mmHg; sars-cov-2 test: (22Dec2021) positive, notes: Delta variant.
Therapeutic measures were taken as a result of vaccination failure, covid-19 pneumonia, acute respiratory distress syndrome, pelvic pain.
The patient date of death was 28Dec2021.
The reported cause of death was covid-19 pneumonia, acute respiratory distress syndrome, pelvic pain.
No autopsy was performed.
Clinical course: 20Dec2021: patient presenting with malaise at home in a context of generalized asthenia, dry cough, fever and diarrhea.
22Dec2021: Positive PCR test.
Delta variant.
24Dec2021: Pelvic pain with cough.
Admitted to the emergency room: fever 39.
5 degrees, saturation 86% on ambient air with hypoxemia 54 mmHg.
The computed tomography confirmed a coronavirus pneumopathy with an expanded form around 20 to 30%.
He was given anticoagulant and dexamethasone in the pneumology department.
25Dec2021: need for high flow oxygen therapy.
26Dec2021: further deterioration and transfer to intensive care.
EVOLUTION: High flow oxygen therapy, non-invasive ventilation and dexamethasone maintained.
Continued deterioration.
On 28Dec2021, signs of major acute respiratory distress with hypoxia and polypnea.
After collegial decision, sedation of the patient and comfort care.
Death on 28Dec2021.
No follow-up attempts are possible.
No further information is expected.
; Reported Cause(s) of Death: covid 19; major acute respiratory distress; pelvic pain