Adverse Event Reporting

VAERS ID 1845744
Gender Female
Age 45
StateCode FR
Pharmaceutical Company MODERNA
Lot Number
Number of vaccinations 1
Vaccinated 2021-06-25
Onset 2021-09-01
Condition Died
Symptoms
  • Electrocardiogram
  • Atrioventricular block

Current Illness

Preexisting Conditions

Other Medications

Previous Vaccinations

Allergies

Laboratory Data

Test Date: 202109; Test Name: ECG; Result Unstructured Data: Abnormal

Write-up

chest pain/chest discomfort/proximal left anterior descending coronary artery completely blocked; This regulatory authority case was reported by an other and describes the occurrence of ATRIOVENTRICULAR BLOCK (chest pain/chest discomfort/proximal left anterior descending coronary artery completely blocked) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.
939600) for COVID-19 vaccination.
No Medical History information was reported.
On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.
On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.
In September 2021, the patient experienced ATRIOVENTRICULAR BLOCK (chest pain/chest discomfort/proximal left anterior descending coronary artery completely blocked) (seriousness criterion death).
The patient died on 09-Oct-2021.
The reported cause of death was proximal left anterior descending coronary artery completely blocked.
An autopsy was performed.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Electrocardiogram: abnormal (abnormal) Abnormal.
No concomitant medications were reported.
No treatment medications were reported.
Patient was found lying on the floor of the room without response and so was admitted to hospital and died after the first aid failed.
The dependents suspected that the cause of death was related to vaccination.
Autopsy was performed on 12-Oct-2021.
Anti PF4 antibody test results were available.
Company Comment - This case concerns a 45-year-old, female patient with no relevant medical history, who experienced the unexpected event of atrioventricular block.
The event occurred on an unknown date after the secoond dose of Spikevax and had a fatal outcome, with death occurring 73 days after the second dose.
The rechallenge was not applicable.
The benefit-risk relationship of Spikevax is not affected by this report.
; Sender's Comments: This case concerns a 45-year-old, female patient with no relevant medical history, who experienced the unexpected event of atrioventricular block.
The event occurred on an unknown date after the secoond dose of Spikevax and had a fatal outcome, with death occurring 73 days after the second dose.
The rechallenge was not applicable.
The benefit-risk relationship of Spikevax is not affected by this report; Reported Cause(s) of Death: proximal left anterior descending coronary artery completely blocked