Adverse Event Reporting
| VAERS ID | 2013410 |
|---|---|
| Gender | Female |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | 2 |
| Vaccinated | 2021-04-30 |
| Onset | 2021-04-30 |
| Condition | Hospitalized Life Threatening Died |
Symptoms
- Inappropriate schedule of product administration
- Malaise
- Arrhythmia
- Pneumonia
- Cardiac failure
Current Illness
Diabetes mellitus
Preexisting Conditions
Medical History/Concurrent Conditions: Elderly; Heart disorder
Other Medications
SIMVASTATINE; PANTOPRAZOLE; NOVORAPID; ENTRESTO; ELIQUIS; FUROSEMIDE; METOPROLOL; ABASAGLAR; METFORMINE [METFORMIN]
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Malaise; Cardiac failure; Cardiac arrhythmia; Pneumonia; inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable Consumer (reporting for mother) from the Regulatory Authority-WEB.
Regulatory number: NL-LRB-00726008 (RA).
This report refers to the second dose of COMIRNATY for the same patient.
An 84 year-old female patient received BNT162b2 (COMIRNATY), administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation; influenza vaccine (INFLUENZA VACCIN), administration date 30Oct2021 (Batch/Lot number: unknown) as dose 1, single for influenza immunisation.
Relevant medical history included: "Elderly" (unspecified if ongoing); "Diabetes mellitus" (ongoing); "Heart disorder" (unspecified if ongoing).
Previous COVID-19 infection was None.
Concomitant medications included: SIMVASTATINE; PANTOPRAZOLE; NOVORAPID; ENTRESTO; ELIQUIS; FUROSEMIDE; METOPROLOL; ABASAGLAR; METFORMINE [METFORMIN].
Vaccination history included: Comirnaty (dose 1), administration date: 26Feb2021, for covid-19 immunization, reaction(s): "Stiff arm".
The following information was reported: CARDIAC FAILURE (death, hospitalization, medically significant, life threatening) with onset 01May2021, outcome "fatal", described as "Cardiac failure"; ARRHYTHMIA (death) with onset 01May2021, outcome "fatal", described as "Cardiac arrhythmia"; PNEUMONIA (death) with onset 01May2021, outcome "fatal", described as "Pneumonia"; MALAISE (hospitalization) with onset 01Nov2021, outcome "unknown", described as "Malaise"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Apr2021, outcome "unknown", described as "inappropriate schedule of vaccine administered".
Clinical course: After the vaccinations, heart failure developed when pneumonia caused a heart rhythm disorder.
Cardiac arrhythmia was treated with Antibiotics and heart medications, cardiac failure was treated with Antibiotics and heart medications, malaise was treated with Hospitalization and pneumonia was treated with Antibiotics and heart medications.
The patient date of death was 2021.
It was unknown if an autopsy was performed.
The lot number for BNT162b2 was not provided and will be requested during follow up.
; Reported Cause(s) of Death: Cardiac arrhythmia; Cardiac failure; Pneumonia