Adverse Event Reporting
| VAERS ID | 2484733 |
|---|---|
| Gender | Male |
| Age | 24 |
| StateCode | FR |
| Pharmaceutical Company | MODERNA |
| Lot Number | 2:3005697. |
| Number of vaccinations | 2 |
| Vaccinated | 2021-09-08 |
| Onset | 2022-04-01 |
| Condition | Hospitalized Life Threatening Permanent Disability |
Symptoms
- Cardiac failure
- Myocarditis
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: COVID-19 immunisation (Spikewax dose 1)
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
HEART FAILURE HFREF; MYOCARDITIS; This case was received via Regulatory authority (Reference number: SE-MPA-2022-019767) on 17-Oct-2022 and was forwarded to Moderna on 17-Oct-2022.
This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC FAILURE (HEART FAILURE HFREF) and MYOCARDITIS (MYOCARDITIS) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch no.
2: 3005697.
) for Prophylactic vaccination.
The patient's past medical history included COVID-19 immunisation (Spikewax dose 1) on 29-Jul-2021.
On 08-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form.
On 01-Apr-2022, the patient experienced CARDIAC FAILURE (HEART FAILURE HFREF) (seriousness criteria hospitalization, disability and life threatening) and MYOCARDITIS (MYOCARDITIS) (seriousness criteria hospitalization, disability and life threatening).
At the time of the report, CARDIAC FAILURE (HEART FAILURE HFREF) and MYOCARDITIS (MYOCARDITIS) had resolved with sequelae.
For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.
No concomitant medications were reported.
No treatment medications were reported.
Company comment: This regulatory authority case reported by a physician concerns a 24-year-old male patient, with no relevant medical history, who experienced the serious (life-threatening, caused hospitalization and disabling), unexpected AESIs of Cardiac failure and Myocarditis which occurred approximately 7 months after second dose of mRNA-1273 vaccine administration.
The events had resolved with sequelae at the time of the report.
No further information regarding clinical course, investigations performed, and treatment given is available for medical review.
The interval between the 2 doses was approximately 40 days (Inappropriate Schedule of Vaccine Administration noted).
The benefit -risk relationship of mRNA -1273 is not affected by this report.
; Sender's Comments: This regulatory authority case reported by a physician concerns a 24-year-old male patient, with no relevant medical history, who experienced the serious (life-threatening, caused hospitalization and disabling), unexpected AESIs of Cardiac failure and Myocarditis which occurred approximately 7 months after second dose of mRNA-1273 vaccine administration.
The events had resolved with sequelae at the time of the report.
No further information regarding clinical course, investigations performed, and treatment given is available for medical review.
The interval between the 2 doses was approximately 40 days (Inappropriate Schedule of Vaccine Administration noted).
The benefit -risk relationship of mRNA -1273 is not affected by this report.