이상반응 보고
| VAERS ID | 1739014 |
|---|---|
| 성별 | 여성 |
| 나이 | 27세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | 3003608 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-07-25 |
| 발병일 | 2021-08-01 |
| 상태 |
증상
- SARS-CoV-2 테스트(SARS-CoV-2 test)
- 월경통(Dysmenorrhoea)
- 월경 불규칙(Menstruation irregular)
- 자궁 통증(Uterine pain)
- 월경전 통증(Premenstrual pain)
- 배란통(Ovulation pain)
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임상 검사
Test Date: 20210710; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
증상 상세
uterine pain; Pain menstrual; Premenstrual pain; Menstrual irregularity; Intermenstrual pain; This case was received via the regulatory authority (Reference number: GB-MHRA-WEBCOVID-202109181538563740-N3BHF) on 19-Sep-2021 and was forwarded to the company on 19-Sep-2021.
This regulatory authority case was reported by a consumer and describes the occurrence of OVULATION PAIN (Intermenstrual pain), MENSTRUATION IRREGULAR (Menstrual irregularity), UTERINE PAIN (uterine pain), PREMENSTRUAL PAIN (Premenstrual pain) and DYSMENORRHOEA (Pain menstrual) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no.
3003608) for COVID-19 vaccination.
No Medical History information was reported.
On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form.
On 01-Aug-2021, the patient experienced OVULATION PAIN (Intermenstrual pain) (seriousness criterion medically significant).
On 11-Aug-2021, the patient experienced MENSTRUATION IRREGULAR (Menstrual irregularity) (seriousness criterion medically significant).
On 22-Aug-2021, the patient experienced PREMENSTRUAL PAIN (Premenstrual pain) (seriousness criterion medically significant).
On 25-Aug-2021, the patient experienced DYSMENORRHOEA (Pain menstrual) (seriousness criterion medically significant).
On an unknown date, the patient experienced UTERINE PAIN (uterine pain) (seriousness criterion medically significant).
On 29-Aug-2021, DYSMENORRHOEA (Pain menstrual) had resolved.
On 30-Aug-2021, PREMENSTRUAL PAIN (Premenstrual pain) had resolved.
At the time of the report, OVULATION PAIN (Intermenstrual pain) and MENSTRUATION IRREGULAR (Menstrual irregularity) had not resolved and UTERINE PAIN (uterine pain) outcome was unknown.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test.
The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.
Concomitant product was not provided by the reporter Treatment product was not provided by the reporter The patient have had no menstrual disorders or pain before.
The patient stated that, Following the vaccine she had premenstrual uterine pain.
Her period was several weeks delayed with no pregnancy throughout this time.
When her period arrived the menstrual pain was severe (8/10) Patient has not tested positive for COVID-19 since having the vaccine Company Comment: This case concerns a 27 year old female with no relevant medical history who experienced the unexpected events of Uterine pain and Dysmenorrhoea along with the unsupported events in the source document of Ovulation pain Menstruation irregular and Prementrual pain.
The event began from 16 to 35 days after the first dose of Moderna-COVID-19 vaccine.
Re-challenge is unknown as no information is reported about the second dose.
Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
The events are assessed as serious by the RA; however, based on medical judgement, current information and the lack of evidence of seriousness the events are considered non-serious.
; Sender's Comments: This case concerns a 27 year old female with no relevant medical history who experienced the unexpected events of Uterine pain and Dysmenorrhoea along with the unsupported events in the source document of Ovulation pain Menstruation irregular and Prementrual pain.
The event began from 16 to 35 days after the first dose of Moderna-COVID-19 vaccine.
Re-challenge is unknown as no information is reported about the second dose.
Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
The events are assessed as serious by the RA; however, based on medical judgement, current information and the lack of evidence of seriousness the events are considered non-serious.