이상반응 보고
| VAERS ID | 2302807 |
|---|---|
| 성별 | 여성 |
| 나이 | 27세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-07-26 |
| 발병일 | 2021-07-29 |
| 상태 |
증상
- 복통(Abdominal pain)
- 임신 테스트(Pregnancy test)
- 초음파 스캔(Ultrasound scan)
- 낙태 실패(Abortion missed)
이환 중 질병
지병
Medical History/Concurrent Conditions: Non-smoker; Comments: Patient had no allergies, had not been drinking alcohol, no specific diet and reports and no other test results reported.
기타 의료
이전 예방접종
알레르기
임상 검사
Test Date: 20210726; Test Name: Pregnancy test; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 202108; Test Name: Sonogram; Result Unstructured Data: Findings showed MISSED ABORTION.
Gestation week 7-8
증상 상세
MISSED ABORTION; ABDOMINAL PAIN; This case was received via Regulatory Agency (Reference number: NO-NOMAADVRE-E2B_00045869) on 27-May-2022 and was forwarded to Moderna on 27-May-2022.
This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION MISSED (MISSED ABORTION) in a 27-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.
The occurrence of additional non-serious events is detailed below.
Patient had no allergies, had not been drinking alcohol, no specific diet and reports and no other test results reported.
The patient's past medical history included Non-smoker.
On 26-Jul-2021 at 1:05 PM, 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 29-Jul-2021, the patient experienced ABDOMINAL PAIN (ABDOMINAL PAIN).
On an unknown date, the patient experienced ABORTION MISSED (MISSED ABORTION) (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, ABORTION MISSED (MISSED ABORTION) and ABDOMINAL PAIN (ABDOMINAL PAIN) outcome was unknown.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jul-2021, Pregnancy test: positive (Positive) Positive.
In August 2021, Ultrasound scan: findings showed missed abortion.
Findings showed MISSED ABORTION.
Gestation week 7-8.
The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.
No treatment medication was reported.
Dosage text was reported as Dose no.
in series: 1 Vaccination site: Left Arm It was reported, the patient started taking dietary supplement for pregnancy on the day the pregnancy was discovered and until the MISSED ABORTION was confirmed.
The patient did not know she was pregnant at the time of the VACCINATION.
In the evening of 26/Jul/2021, she took a PREGNANCY TEST which was positive, 2-3 weeks since conceiving.
Company Comment: This Regulatory Authority case of maternal exposure during pregnancy concerns a 27-year-old female patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Abortion missed.
Patient took a pregnancy test the same day after the first dose of mRNA-1273 vaccine, which was positive, 2-3 weeks since conceiving.
She started taking dietary supplement for pregnancy on the day the pregnancy was discovered, until missed abortion was confirmed.
3 days after the first dose of mRNA-1273 vaccine, patient experienced abdominal pain for about 1 hour.
3 weeks later, patient went to gynecologist for a sonogram (gestation week 7-8) and discovered a Missed abortion.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
; Sender's Comments: This Regulatory Authority case of maternal exposure during pregnancy concerns a 27-year-old female patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Abortion missed.
Patient took a pregnancy test the same day after the first dose of mRNA-1273 vaccine, which was positive, 2-3 weeks since conceiving.
She started taking dietary supplement for pregnancy on the day the pregnancy was discovered, until missed abortion was confirmed.
3 days after the first dose of mRNA-1273 vaccine, patient experienced abdominal pain for about 1 hour.
3 weeks later, patient went to gynecologist for a sonogram (gestation week 7-8) and discovered a Missed abortion.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.