Adverse Event Reporting
| VAERS ID | 2040812 |
|---|---|
| Gender | Female |
| Age | 66 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | 2 |
| Vaccinated | 2021-06-15 |
| Onset | 2021-06-15 |
| Condition | Died |
Symptoms
- Influenza like illness
- Vaccination site pain
- Pulmonary oedema
- Immunisation reaction
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Chronic obstructive airways disease; Fibromyalgia worsened; Hypertension arterial; Hypertensive heart disease NOS
Other Medications
NORDAZ; ZOPICLONE; KARDEGIC; BISOPROLOL; ZANEXTRA; LECTIL; LASILIX [FUROSEMIDE]; VENTOLINE [SALBUTAMOL]; CRESTOR; INEXIUM [ESOMEPRAZOLE MAGNESIUM]; LAROXYL; CORTANCYL; ORAMORPH [MORPHINE SULFATE]; PANTOPRAZOLE; METEOSPASMYL [ALVERINE CITRAT
Previous Vaccinations
Allergies
Laboratory Data
Write-up
influenza-like illness; pain at the injection site; pulmonary edema; Reactogenicity event; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Agency Regulatory Authority-WEB.
Regulatory number: FR-AFSSAPS-BR20214223.
A 66 year-old female patient received BNT162b2 (COMIRNATY), intramuscular, administration date 15Jun2021 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single for COVID-19 immunisation.
Relevant medical history included: "Fibromyalgia worsened" (unspecified if ongoing); "Chronic obstructive airways disease" (unspecified if ongoing); "Hypertension arterial" (unspecified if ongoing); "Hypertensive heart disease NOS" (unspecified if ongoing).
Concomitant medications included: NORDAZ; ZOPICLONE; KARDEGIC; BISOPROLOL; ZANEXTRA; LECTIL; LASILIX [FUROSEMIDE]; VENTOLINE [SALBUTAMOL]; CRESTOR; INEXIUM [ESOMEPRAZOLE MAGNESIUM]; LAROXYL; CORTANCYL; ORAMORPH [MORPHINE SULFATE]; PANTOPRAZOLE; METEOSPASMYL [ALVERINE CITRATE;SIMETICONE]; IXPRIM.
Vaccination history included: COVID-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation.
The following information was reported: PULMONARY OEDEMA (death) with onset 02Jul2021, outcome "fatal", described as "pulmonary edema"; IMMUNISATION REACTION (non-serious) with onset 15Jun2021, outcome "recovered", described as "Reactogenicity event"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "influenza-like illness"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site".
Clinical course: This patient had presented with influenza-like illness and pain at the injection site following the injection.
15Jun2021, 2nd injection of the Comirnaty vaccine (batch unknown) followed by flu syndrome and pain at the injection site.
On 02Jul2021, the patient was found dead in her bed in the morning by her son.
This one reports that the face was blue with the presence of foam around the mouth.
The doctor who observed the death concluded that it was natural.
There was no autopsy despite the request of the patient's son.
Vaccine or drug origin.
Toxic research has not been carried out.
The patient date of death was 02Jul2021.
The reported cause of death was pulmonary oedema.
No autopsy was performed.
No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No further information is expected.
; Reported Cause(s) of Death: pulmonary edema