이상반응 보고
| VAERS ID | 1787030 |
|---|---|
| 성별 | 여성 |
| 나이 | 30세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-07-30 |
| 발병일 | 2021-07-30 |
| 상태 | 회복 |
증상
- 자연 낙태(Abortion spontaneous)
- 임신 중 모성 노출(Maternal exposure during pregnancy)
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증상 상세
Spontanabort; Maternal exposure during pregnancy; This case was received via Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00052718) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021.
This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS in a 30-year-old female patient who received mRNA-1273 (Spikevax) for Vaccination.
The occurrence of additional non-serious events is detailed below.
No Medical History information was reported.
On 30-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form.
Last menstrual period and estimated date of delivery were not provided.
On 30-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).
On 03-Sep-2021, the patient experienced ABORTION SPONTANEOUS (seriousness criterion medically significant).
The delivery occurred on an unknown date, which was reported as Spontaneous Abortion.
For foetus 1, The outcome was reported as Spontaneous Abortion NOS.
On 30-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.
On 23-Sep-2021, ABORTION SPONTANEOUS (Spontanabort) had resolved.
The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.
Concomitant medication was not provided.
Treatment information was not provided.
Company Comment: This case concerns 30-year-old, female patient with no relevant medical history.
The patient presents with serious event of Abortion spontaneous, and a non-serious event Maternal exposure during pregnancy 1 month 5 days after first dose of Spikevax.
The reporter didn't provide the causality of event.
Patient experienced AEs after the first dose and no information about second dose is available rechallenge unknown.
The benefit-risk relationship of Spikevax is not affected by this report.
Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Translation document received on 07-oct-2021 contains Non-significant information.
; Reporter's Comments: Upgraded to Serious due to SPONTANEOUS ABORTION : Important Medical Events.
; Sender's Comments: This case concerns 30-year-old, female patient with no relevant medical history.
The patient presents with serious event of Abortion spontaneous, and a non-serious event Maternal exposure during pregnancy 1 month 5 days after first dose of Spikevax.
The reporter didn't provide the causality of event.
Patient experienced AEs after the first dose and no information about second dose is available rechallenge unknown.
The benefit-risk relationship of Spikevax is not affected by this report.