Adverse Event Reporting

VAERS ID 2203627
Gender Female
Age 83
StateCode FR
Pharmaceutical Company MODERNA
Lot Number
Number of vaccinations 3
Vaccinated 2021-12-08
Onset 2021-12-09
Condition Died
Symptoms
  • Cerebral haemorrhage

Current Illness

Heart disorder

Preexisting Conditions

Comments: pre-existing conditions include Cardiac patient, diabetic

Other Medications

Previous Vaccinations

Allergies

Laboratory Data

Write-up

fever, runny nose; This case was received via the regulatory authority (Reference number: DE-PEI-202200087361) on 23-Mar-2022 and was forwarded to Moderna on 23-Mar-2022.
This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (fever, runny nose) in an 83-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.
pre-existing conditions include Cardiac patient, diabetic.
Concurrent medical conditions included Heart disorder.
On 08-Dec-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form.
On 09-Dec-2021, the patient experienced CEREBRAL HAEMORRHAGE (fever, runny nose) (seriousness criterion death).
The patient died on 03-Jan-2022.
The reported cause of death was Cerebral haemorrhage.
It is unknown if an autopsy was performed.
Concomitant medication was not reported.
Treatment information was not reported.
Company Comment: This regulatory case concerns an 83-year-old, female patient with relevant medical history of Diabetes Mellitus, who experienced the unexpected, serious (fatal) ADR of cerebral haemorrhage after administration of the third dose of the Moderna mRNA-1273 vaccine.
The reporter stated that 9 days after vaccination, the patient had 'brain bleeding'.
No further details were provided.
The patient expired on 03Jan2022 (26 days after vaccination).
It is unknown if an autopsy was performed.
However, the reported cause of death was 'Cerebral haemorrhage'.
The medical history of Diabetes Mellitus as well the patient's advanced age, which are known risk factors for cerebral hemorrhage, remain as confounders.
The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
; Reporter's Comments: Are you or the person concerned aware of allergies? If yes, which one? No information about risk factors or pre-existing conditions Cardiac patient, diabetic / 9 days after vaccination Brain bleeding; Sender's Comments: This regulatory case concerns an 83-year-old, female patient with relevant medical history of Diabetes Mellitus, who experienced the unexpected, serious (fatal) ADR of cerebral haemorrhage after administration of the third dose of the Moderna mRNA-1273 vaccine.
The reporter stated that 9 days after vaccination, the patient had 'brain bleeding'.
No further details were provided.
The patient expired on 03Jan2022 (26 days after vaccination).
It is unknown if an autopsy was performed.
However, the reported cause of death was 'Cerebral haemorrhage'.
The medical history of Diabetes Mellitus as well the patient's advanced age, which are known risk factors for cerebral hemorrhage, remain as confounders.
The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
; Reported Cause(s) of Death: Cerebral haemorrhage