이상반응 보고
| VAERS ID | 1576119 |
|---|---|
| 성별 | 여성 |
| 나이 | 29세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | 3003608 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-07-31 |
| 발병일 | 2021-07-31 |
| 상태 |
증상
- 피로(Fatigue)
- 사지의 통증(Pain in extremity)
- 발열(Pyrexia)
- 복통 상부(Abdominal pain upper)
- 인플루엔자와 같은 질병(Influenza like illness)
- 편두통(Migraine)
- SARS-CoV-2 테스트(SARS-CoV-2 test)
- 초음파 스캔(Ultrasound scan)
- 병(Illness)
- 임신 중 모성 노출(Maternal exposure during pregnancy)
이환 중 질병
Migraine (Suffer with migraines but not had one for 3 years); Pregnancy (Twin pregnancy)
지병
기타 의료
FOLIC ACID; XONVEA
이전 예방접종
알레르기
임상 검사
Test Date: 20210730; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 2021; Test Name: Ultrasound scan; Result Unstructured Data: Findings: Twin pregnancy.
증상 상세
Maternal exposure during pregnancy; Migraine; Flu like symptoms; Sickness; Aches & pains in legs; Exhaustion; Fever; Stomachache; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), INFLUENZA LIKE ILLNESS (Flu like symptoms), ABDOMINAL PAIN UPPER (Stomachache), ILLNESS (Sickness), PAIN IN EXTREMITY (Aches & pains in legs), FATIGUE (Exhaustion), PYREXIA (Fever) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no.
3003608) for COVID-19 vaccination.
Concurrent medical conditions included Pregnancy (Twin pregnancy) and Migraine (Suffer with migraines but not had one for 3 years).
Concomitant products included FOLIC ACID for Folic acid supplementation, DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (XONVEA) for Hyperemesis gravidarum.
On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form.
Last menstrual period and estimated date of delivery were not provided.
On 31-Jul-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant).
On 01-Aug-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criterion medically significant).
On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant).
On 02-Aug-2021, ILLNESS (Sickness) had resolved.
At the time of the report, MIGRAINE (Migraine), INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Exhaustion) and PYREXIA (Fever) had not resolved, ABDOMINAL PAIN UPPER (Stomachache) was resolving, PAIN IN EXTREMITY (Aches & pains in legs) had resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: unknown (normal) Findings: Twin pregnancy.
.
On 30-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative.
The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown.
No treatment medication was provided.
Patient was exposed to the medicine Second-trimester (13-28 weeks).
Suffered with migraines but not had one for 3 years until the vaccine.
Gestation period was 13-28 weeks.
Company Comment: This is a case of product exposure during pregnancy with associated adverse events of migraine, influenza like illness, abdominal pain upper, illness, pain in extremity, fatigue and pyrexia.
Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
As this case was reported by regulatory authority, no further information is requested.
; Sender's Comments: This is a case of product exposure during pregnancy with associated adverse events of migraine, influenza like illness, abdominal pain upper, illness, pain in extremity, fatigue and pyrexia.
Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
As this case was reported by regulatory authority, no further information is requested.