이상반응 보고
| VAERS ID | 1828168 |
|---|---|
| 성별 | 여성 |
| 나이 | 37세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | 214003 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-09-27 |
| 발병일 | |
| 상태 | 입원 회복 |
증상
- 질 출혈(Vaginal haemorrhage)
- 임신 중 모성 노출(Maternal exposure during pregnancy)
- 양수(Amniorrhoea)
- 노동 위협(Threatened labour)
이환 중 질병
Pregnant
지병
기타 의료
이전 예방접종
알레르기
임상 검사
증상 상세
AMNIORRHOEA; VAGINAL BLEEDING (BLOOD CLOT AS SIGN OF PRIOR BLEEDING); THREATENED PREMATURE LABOR; Maternal exposure during pregnancy; This case was received via Regulatory Agency (Reference number: NO-NOMAADVRE-E2B_00055677) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021.
This regulatory authority prospective pregnancy case was reported by a physician and describes the occurrence of AMNIORRHOEA (AMNIORRHOEA), VAGINAL HAEMORRHAGE (VAGINAL BLEEDING (BLOOD CLOT AS SIGN OF PRIOR BLEEDING)) and THREATENED LABOUR (THREATENED PREMATURE LABOR) in a 37-year-old female patient who received mRNA-1273 (Spikevax) (batch no.
214003) for Vaccination.
The occurrence of additional non-serious events is detailed below.
Concurrent medical conditions included Pregnant.
On 27-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form.
Last menstrual period and estimated date of delivery were not provided.
On an unknown date, the patient experienced AMNIORRHOEA (AMNIORRHOEA) (seriousness criterion hospitalization), VAGINAL HAEMORRHAGE (VAGINAL BLEEDING (BLOOD CLOT AS SIGN OF PRIOR BLEEDING)) (seriousness criterion hospitalization), THREATENED LABOUR (THREATENED PREMATURE LABOR) (seriousness criterion hospitalization) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).
At the time of the report, AMNIORRHOEA (AMNIORRHOEA), VAGINAL HAEMORRHAGE (VAGINAL BLEEDING (BLOOD CLOT AS SIGN OF PRIOR BLEEDING)) and THREATENED LABOUR (THREATENED PREMATURE LABOR) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.
For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.
Treatment medication was not provided Concomitant medication was not provided Spontaneous rupture of the membranes gestation week 23+3 weeks with concomitant passing of organized clot vaginally as evidence of previous bleeding was reported foe events COMPANY COMMENT: This case of maternal exposure during pregnancy (gestational age 23 plus weeks) concerns a 37-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of Amniorrhoea, Vaginal haemorrhage and Threatened labour.
The events occurred unspecified time after the second dose of Spikevax.
Rechallenge was not applicable as the events occurred following the second dose.
The benefit risk relation of Spikevax is not affected by this report.
12-OCT-21 Regulatory Authority : requested additional information.
If new medical information is received, report will be updated Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Translation received on 25-Oct-2021- event verbatim and sender comments updated.
; Reporter's Comments: REQUEST FOR ADDITIONAL INFORMATION Since the report describes a suspected adverse event that is serious, we would like to have sent a copy of the relevant discharge summaries/medical record/laboratory results/other investigations.
This may be important in order to assess the incident in the best possible way.
A hard copy of the discharge summary/medical record note can also be sent to the Public Health, [Vaccine Adverse Events]) and the reference number.
Thank you for reporting your suspected adverse effect following a vaccination.
Since the vaccine is new, it is subject to special surveillance in order to detect new safety information as quickly as possible.
It is particularly important that serious and/or unusual adverse events be reported.
Your report is therefore important for increasing knowledge about side effects that have not been discovered in studies, and is an important contribution to the international cooperation to maintain safe vaccination worldwide.
Reports after coronavirus vaccination in the Adverse Effects Register are processed by the of Public Health in cooperation with the Regulatory authority.
We do not have the capacity to send individual assessments of adverse event reports at this time.
Causality is assessed according to international criteria (1).
If you have further information related to the event, such as information about the outcome, a copy from the medical record/discharge summary/laboratory results and/or other investigations, this can be sent in response to this message.
The information is treated securely, and this dialogue will be deleted automatically after 4 months.
The processing and storage of personal data is done in accordance with the Regulatory Authority Guidelines.
For updated information and advice on the use of vaccines and precautions, please refer to the Vaccination Questions about the coronavirus vaccine which cannot be answered by the local responsible specialist should be sent Regulatory Authority We request that certain categories of personal data (health information) not be sent by email.
If it is not possible to ask a question without including such information, we recommend calling the vaccine telephone Sender's Comments: This case of maternal exposure during pregnancy (gestational age 23 plus weeks) concerns a 37-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of Amniorrhoea, Vaginal haemorrhage and Threatened labour.
The events occurred unspecified time after the second dose of Spikevax.
Rechallenge was not applicable as the events occurred following the second dose.
The benefit risk relation of Spikevax is not affected by this report.