Adverse Event Reporting
| VAERS ID | 1847226 |
|---|---|
| Gender | Female |
| Age | 37 |
| StateCode | FR |
| Pharmaceutical Company | MODERNA |
| Lot Number | |
| Number of vaccinations | 2 |
| Vaccinated | 2021-08-09 |
| Onset | 2021-08-09 |
| Condition | Recovered |
Symptoms
- Maternal exposure during pregnancy
- Uterine contractions abnormal
Current Illness
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Uterine contractions similar to afterpains; Maternal exposure during pregnancy; This case was received via Regulatory Authority (Reference number: ES-AEMPS-977077) on 29-Oct-2021 and was forwarded to Moderna on 29-Oct-2021.
This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of UTERINE CONTRACTIONS ABNORMAL (Uterine contractions similar to afterpains) in a 37-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 09-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form.
Last menstrual period and estimated date of delivery were not provided.
On 09-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).
On 10-Aug-2021, the patient experienced UTERINE CONTRACTIONS ABNORMAL (Uterine contractions similar to afterpains) (seriousness criterion medically significant).
On 09-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.
On 12-Aug-2021, UTERINE CONTRACTIONS ABNORMAL (Uterine contractions similar to afterpains) had resolved.
No concomitant and treatment medication were provided Company Comment :This case concerns a 37-year-old, female patient with no relevant medical history, who experienced vaccine exposure during pregnancy and the unexpected, serious event of uterine contractions abnormal.
The gestation period at exposure was not provided.
The event uterine contractions abnormal occurred 1 day after administration of the second dose of the Moderna COVID-19 Vaccine.
The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the event uterine contractions abnormal is medically significant.
Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Translation document received on 29-Oct-2021 which included translation for verbatim of events, anatomical location and dose number.
; Sender's Comments: This case concerns a 37-year-old, female patient with no relevant medical history, who experienced vaccine exposure during pregnancy and the unexpected, serious event of uterine contractions abnormal.
The gestation period at exposure was not provided.
The event uterine contractions abnormal occurred 1 day after administration of the second dose of the Moderna COVID-19 Vaccine.
The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the event uterine contractions abnormal is medically significant.