Adverse Event Reporting
| VAERS ID | 1908798 |
|---|---|
| Gender | Female |
| Age | 42 |
| StateCode | FR |
| Pharmaceutical Company | MODERNA |
| Lot Number | 3002920 |
| Number of vaccinations | 1 |
| Vaccinated | 2019-08-16 |
| Onset | 2021-07-01 |
| Condition | Permanent Disability |
Symptoms
- Amenorrhoea
Current Illness
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
MONTHLY BLEEDING HAS STOPPED; This case was received via Regulatory Agency (Reference number: SE-MPA-2021-092467) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021.
This regulatory authority case was reported by a consumer and describes the occurrence of AMENORRHOEA (MONTHLY BLEEDING HAS STOPPED) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no.
3002920) for an unknown indication.
Co-suspect product included non-company product LEVONORGESTREL (JAYDESS) for Birth control.
No Medical History information was reported.
On 16-Aug-2019, the patient started LEVONORGESTREL (JAYDESS) (Intra-uterine) 13.
5 mg.
On 28-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form.
In July 2021, the patient experienced AMENORRHOEA (MONTHLY BLEEDING HAS STOPPED) (seriousness criterion disability).
At the time of the report, AMENORRHOEA (MONTHLY BLEEDING HAS STOPPED) had not resolved.
The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.
Concomitant medication was not provided.
Treatment information was not reported.
Company Comment: This case concerns a 42 year old female patient with medical history of use of Levonorgestrel, who experienced the expected event of amenorrhoea.
The event occurred on an unknown date in July after the first dose of mRNA-1273 vaccine.
The rechallenge was not applicable as this is the first dose.
Patient's medical history of Levonorgestrel remains a confounder.
The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Translated document received on 23-NOV-2021 include event verbatim, pharmaceutical form of vaccine; Sender's Comments: This case concerns a 42 year old female patient with medical history of use of Levonorgestrel, who experienced the expected event of amenorrhoea.
The event occurred on an unknown date in July after the first dose of mRNA-1273 vaccine.
The rechallenge was not applicable as this is the first dose.
Patient's medical history of Levonorgestrel remains a confounder.
The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.