이상반응 보고
| VAERS ID | 1919168 |
|---|---|
| 성별 | 여성 |
| 나이 | 30세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-07-30 |
| 발병일 | 2021-11-05 |
| 상태 |
증상
- 태아 심박수 비정상(Foetal heart rate abnormal)
이환 중 질병
지병
기타 의료
이전 예방접종
알레르기
임상 검사
증상 상세
No fetal heartbeat at week 32 of pregnancy; This regulatory authority retrospective pregnancy case was reported by an other health care professional and describes the occurrence of FOETAL HEART RATE ABNORMAL (No fetal heartbeat at week 32 of pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.
No Medical History information was reported.
On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form.
Last menstrual period and estimated date of delivery were not provided.
On 05-Nov-2021, the patient experienced FOETAL HEART RATE ABNORMAL (No fetal heartbeat at week 32 of pregnancy) (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.
At the time of the report, FOETAL HEART RATE ABNORMAL (No fetal heartbeat at week 32 of pregnancy) outcome was unknown.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.
On 24-Oct-2021, prenatal examination showed no abnormality.
On 01-Nov-2021, the patient received the vaccine.
On 04-Nov-2021, prenatal examination found that the fetus had no heart beat.
On 15-Nov-2021, the patient was called to offer care and informed that returned home without discomfort.
Till then, the patient was still in confinement due to abortion (not dissected).
Company Comment :This is a regulatory case concerning an 30-year-old female pregnant patient with no clinical history who experienced the unexpected event of FOETAL HEART RATE ABNORMAL.
The event occurred 95 days after the second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about second dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Concomitant product information was not provided.
Treatment information was not provided.
; Sender's Comments: This is a regulatory case concerning an 30-year-old female pregnant patient with no clinical history who experienced the unexpected event of FOETAL HEART RATE ABNORMAL.
The event occurred 95 days after the second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about second dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.