이상반응 보고
| VAERS ID | 1667674 |
|---|---|
| 성별 | 여성 |
| 나이 | 36세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | 3004493 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-07-26 |
| 발병일 | 2021-07-26 |
| 상태 |
증상
- 초음파 복부(Ultrasound abdomen)
- 임신 중 모성 노출(Maternal exposure during pregnancy)
- 낙태 실패(Abortion missed)
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임상 검사
Test Date: 20210810; Test Name: Ultrasound abdomen; Result Unstructured Data: showed missed abortion
증상 상세
Missed abortion; Maternal exposure during pregnancy, first trimester; This case was received via a regulatory authority (Reference number: DK-DKMA-ADR 25779907) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021.
This regulatory authority retrospective pregnancy case was reported by a physician and describes the occurrence of ABORTION MISSED (Missed abortion) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, first trimester) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no.
3004493) for COVID-19 immunisation.
No Medical History information was reported.
On 26-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 26-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, first trimester) (seriousness criterion medically significant).
In August 2021, the patient experienced ABORTION MISSED (Missed abortion) (seriousness criterion medically significant).
The delivery occurred on an unknown date, which was reported as Abortion NOS.
For foetus 1, The outcome was reported as Spontaneous Abortion NOS.
On 26-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy, first trimester) had resolved.
On 10-Aug-2021, ABORTION MISSED (Missed abortion) had not resolved.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, Ultrasound abdomen: abnormal (abnormal) showed missed abortion.
The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.
For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.
No concomitant medications are provided, Treatment to the events not reported.
Company Comment: This is a case of product exposure during pregnancy with associated abortion missed for this 36-year-old female.
Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
; Sender's Comments: This is a case of product exposure during pregnancy with associated abortion missed for this 36-year-old female.
Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.