Adverse Event Reporting
| VAERS ID | 2425806 |
|---|---|
| Gender | Female |
| Age | 87 |
| StateCode | FR |
| Pharmaceutical Company | MODERNA |
| Lot Number | 216043 |
| Number of vaccinations | |
| Vaccinated | 2020-08-10 |
| Onset | 2022-06-23 |
| Condition | Permanent Disability |
Symptoms
- Electrocardiogram
- Atrial fibrillation
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Deafness; Mitral regurgitation
Other Medications
NEBIVOLOL
Previous Vaccinations
Allergies
Laboratory Data
Test Name: ECG; Result Unstructured Data: Atrial fibrillation
Write-up
PALPITATIONS AND IRREGULAR PULSE / A FIB ON ECG / NOW DEVELOPED A FIB WHICH STARTED AFTER SHE GOT THE MODERNA VACCINE / CONFIRMED ATRIAL FIBRILLATION; This case was received via Regulatory Authority (Reference number: IE-HPRA-2022-098140) on 29-Aug-2022 and was forwarded to Moderna on 29-Aug-2022.
This regulatory authority case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (PALPITATIONS AND IRREGULAR PULSE / A FIB ON ECG / NOW DEVELOPED A FIB WHICH STARTED AFTER SHE GOT THE MODERNA VACCINE / CONFIRMED ATRIAL FIBRILLATION) in an 87-year-old female patient who received mRNA-1273 (Spikevax) (batch no.
216043) for COVID-19 immunisation.
Co-suspect product included non-company product NEBIVOLOL for Ventricular extrasystoles.
The patient's past medical history included Mitral regurgitation.
Concurrent medical conditions included Deafness.
On 10-Aug-2020, the patient started NEBIVOLOL (unknown route) 1.
25 milligram.
On 21-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .
25 milliliter.
On 23-Jun-2022, the patient experienced ATRIAL FIBRILLATION (PALPITATIONS AND IRREGULAR PULSE / A FIB ON ECG / NOW DEVELOPED A FIB WHICH STARTED AFTER SHE GOT THE MODERNA VACCINE / CONFIRMED ATRIAL FIBRILLATION) (seriousness criteria disability and medically significant).
At the time of the report, ATRIAL FIBRILLATION (PALPITATIONS AND IRREGULAR PULSE / A FIB ON ECG / NOW DEVELOPED A FIB WHICH STARTED AFTER SHE GOT THE MODERNA VACCINE / CONFIRMED ATRIAL FIBRILLATION) had not resolved.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: Atrial fibrillation.
For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.
No relevant concomitant medications were reported.
Treatment medication was not provided by the reporter.
CC: This regulatory authority case concerns a 87 year old female patient, with a relevant history of mitral regurgitation and concomitant use of nebivolol for ventricular extrasystoles since August 2020, who experienced the unexpected, serious (medically significant, disability) adverse event of special interest Atrial fibrillation, which occurred two days after the booster dose of mRNA-1273 vaccine.
The outcome was reported as not resolved.
It was reported that patient had palpitations and irregular pulse.
Electrocardiogram done showed Atrial fibrillation.
Underlying history of mitral regurgitation, the patient's age and concomitant use of nebivolol for ventricular extrasystoles since August 2020 could be confounders for the event.
The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
; Sender's Comments: This regulatory authority case concerns a 87 year old female patient, with a relevant history of mitral regurgitation and concomitant use of nebivolol for ventricular extrasystoles since August 2020, who experienced the unexpected, serious (medically significant, disability) adverse event of special interest Atrial fibrillation, which occurred two days after the booster dose of mRNA-1273 vaccine.
The outcome was reported as not resolved.
It was reported that patient had palpitations and irregular pulse.
Electrocardiogram done showed Atrial fibrillation.
Underlying history of mitral regurgitation, the patient's age and concomitant use of nebivolol for ventricular extrasystoles since August 2020 could be confounders for the event.
The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.