Adverse Event Reporting
| VAERS ID | 2013059 |
|---|---|
| Gender | Female |
| Age | 86 |
| StateCode | FR |
| Pharmaceutical Company | MODERNA |
| Lot Number | 023F21A |
| Number of vaccinations | |
| Vaccinated | 2021-11-27 |
| Onset | 2021-11-28 |
| Condition | Died |
Symptoms
- Cardiac arrest
Current Illness
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
AFTER INOCULATION OF A THIRD DOSE OF THE MODERN VACCINE THAT OCCURRED AT HOME IN THE MORNING THROUGH A PRIMARY DOCTOR AT 10:30 A.
M.
, MY MOTHER HAD A CARDIAC ARREST IN THE NIGHT AT about 4 59 A.
M.
; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-821381) on 25-Dec-2021 and was forwarded to Moderna on 25-Dec-2021.
This regulatory authority case was reported by a consumer and describes the occurrence of CARDIAC ARREST (AFTER INOCULATION OF A THIRD DOSE OF THE MODERN VACCINE THAT OCCURRED AT HOME IN THE MORNING THROUGH A PRIMARY DOCTOR AT 10:30 A.
M.
, MY MOTHER HAD A CARDIAC ARREST IN THE NIGHT AT about 4 59 A.
M.
) in an 86-year-old female patient who received mRNA-1273 (Spikevax) (batch no.
023F21A) for COVID-19 vaccination.
No Medical History information was reported.
On 27-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .
5 dosage form.
On 28-Nov-2021, the patient experienced CARDIAC ARREST (AFTER INOCULATION OF A THIRD DOSE OF THE MODERN VACCINE THAT OCCURRED AT HOME IN THE MORNING THROUGH A PRIMARY DOCTOR AT 10:30 A.
M.
, MY MOTHER HAD A CARDIAC ARREST IN THE NIGHT AT about 4 59 A.
M.
) (seriousness criterion death).
The reported cause of death was after inoculation of a third dose of the modern vaccine that occurred at home in the morning through a primary doctor at 10:30 a.
m.
, my mother had a cardiac arrest in the night at about 4 59 a.
m.
.
It is unknown if an autopsy was performed.
No concomitant medication information was reported.
High Blood Pressure, High Cholesterol (Taking Medication) Blood Circulation Problems Lower Limbs 1st batch dose 3001655-01 administered on 09/04/2021; MAP pending for communication of any ADRs.
2nd batch dose 3001655-16 administered on 07/05/2021; MAP pending for communication of any ADRs.
No treatment medication information was reported 1st batch dose 3001655-01 administered on 09/04/2021; MAP pending for communication of any ADRs.
2nd batch dose 3001655-16 administered on 07/05/2021; MAP pending for communication of any ADRs.
This is a regulatory case concerning an 86-year-old female patient with relevant medical history of high blood pressure, high cholesterol blood circulation problems lower limbs, who experienced the serious fatal unexpected event of cardiac arrest.
The event occurred on next day after the unknown dose of mRNA-1273 vaccine administration.
The event was assessed as related to the product administration.
The rechallenge was not applicable.
The medical history of high blood pressure, high cholesterol blood circulation problems lower limbs considered as confounders in this geriatric patient.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Follow up-received: No new information added.
; Reporter's Comments: HIGH BLOOD PRESSURE, HIGH CHOLESTEROL (TAKING MEDICATION) BLOOD CIRCULATION PROBLEMS LOWER LIMBS; Sender's Comments: This is a regulatory case concerning an 86-year-old female patient with relevant medical history of high blood pressure, high cholesterol blood circulation problems lower limbs, who experienced the serious fatal unexpected event of cardiac arrest.
The event occurred on next day after the unknown dose of mRNA-1273 vaccine administration.
The event was assessed as related to the product administration.
The rechallenge was not applicable.
The medical history of high blood pressure, high cholesterol blood circulation problems lower limbs considered as confounders in this geriatric patient.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
; Reported Cause(s) of Death: AFTER INOCULATION OF A THIRD DOSE OF THE MODERN VACCINE THAT OCCURRED AT HOME IN THE MORNING THROUGH A PRIMARY DOCTOR AT 10:30 A.
M.
, MY MOTHER HAD A CARDIAC ARREST IN THE NIGHT AT about 4 59 A.
M.