Adverse Event Reporting
| VAERS ID | 1845671 |
|---|---|
| Gender | Female |
| Age | 30 |
| StateCode | FR |
| Pharmaceutical Company | MODERNA |
| Lot Number | |
| Number of vaccinations | 1 |
| Vaccinated | 2021-05-28 |
| Onset | 2021-07-02 |
| Condition | Recovered |
Symptoms
- Maternal exposure during pregnancy
- Heavy menstrual bleeding
- Polymenorrhoea
- Unintended pregnancy
Current Illness
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
My cycle was also longer than normal after the vaccination, because I got pregnant right before I should have had my period again.
(Yes I know the exact date I conceived.
); Heavier and earlier menstruation; Heavier and earlier menstruation; maternal exposure during pregnancy; This case was received via Regulatory Authority (Reference number: NL-LRB-00694566) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021.
This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of UNINTENDED PREGNANCY (My cycle was also longer than normal after the vaccination, because I got pregnant right before I should have had my period again.
(Yes I know the exact date I conceived.
)) in a 30-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.
The occurrence of additional non-serious events is detailed below.
No Medical History information was reported.
On 28-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form.
On 02-Jul-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form.
Last menstrual period and estimated date of delivery were not provided.
On 02-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy).
On 07-Jul-2021, the patient experienced POLYMENORRHOEA (Heavier and earlier menstruation) and HEAVY MENSTRUAL BLEEDING (Heavier and earlier menstruation).
On an unknown date, the patient experienced UNINTENDED PREGNANCY (My cycle was also longer than normal after the vaccination, because I got pregnant right before I should have had my period again.
(Yes I know the exact date I conceived.
)) (seriousness criterion medically significant).
On 02-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.
At the time of the report, UNINTENDED PREGNANCY (My cycle was also longer than normal after the vaccination, because I got pregnant right before I should have had my period again.
(Yes I know the exact date I conceived.
)), POLYMENORRHOEA (Heavier and earlier menstruation) and HEAVY MENSTRUAL BLEEDING (Heavier and earlier menstruation) outcome was unknown.
no concomitant and treatment medications are provided by the reporter.
This is a regulatory pregnancy case concerning a 30-year-old female patient with no reported medical history, who experienced the unexpected serious event Unintended pregnancy and the non-serious polymenorrhoea and heavy menstrual bleeding.
The events polymenorrhoea and heavy menstrual bleeding occurred approximately 5 days after the second dose of mRNA-1273 Moderna vaccine.
No start date was provided for unintended pregnancy.
Event seriousness for unintended pregnancy (medically significant) assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a serious medical condition.
The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Translated document received on 01-NOV- 2021, event verbatims were translated to English.
; Reporter's Comments: Since the nature of the reported reaction does not imply seriousness according to one of the CIOMS criteria, the reaction unintended pregnancy was considered as nonserious by the Regulatory Authority .
; Sender's Comments: This is a regulatory pregnancy case concerning a 30-year-old female patient with no reported medical history, who experienced the unexpected serious event Unintended pregnancy and the non-serious polymenorrhoea and heavy menstrual bleeding.
The events polymenorrhoea and heavy menstrual bleeding occurred approximately 5 days after the second dose of mRNA-1273 Moderna vaccine.
No start date was provided for unintended pregnancy.
Event seriousness for unintended pregnancy (medically significant) assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a serious medical condition.
The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.