이상반응 보고
| VAERS ID | 1953798 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FC5089 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-07-30 |
| 발병일 | |
| 상태 |
증상
- 임신 테스트(Pregnancy test)
- 월경 지연(Menstruation delayed)
- 자연 낙태(Abortion spontaneous)
- 초음파 태아(Ultrasound foetal)
- 심한 월경 출혈(Heavy menstrual bleeding)
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임상 검사
Test Date: 20210828; Test Name: pregnancy test; Result Unstructured Data: Test Result:positive; Comments: which showed I was about 1-2 weeks pregnant; Test Date: 2021; Test Name: ultrasound; Result Unstructured Data: Test Result:embryo appeared to have died; Comments: In the 8th week the embryo appeared to have died, but the ultrasound was very noisy.
; Test Date: 2021; Test Name: ultrasound; Result Unstructured Data: Test Result:definitively a threatened miscarriage; Comments: Had another ultrasound in the 10th week, in which the embryo and amniotic sac were measured and compared with the first ultrasound, where the conclusion was definitively a threatened miscarriage.
The uterus with contents was clearly visible in the 2nd ultrasound.
증상 상세
Miscarriage; disruption of the menstrual cycle/ menstruation lasted 8 days instead of 4 days; disruption of the menstrual cycle, this was delayed by 10 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB.
The reporter is the patient.
Regulatory number: NL-LRB-00715912.
An adult female patient (pregnant) received bnt162b2 (COMIRNATY), administration date 30Jul2021 (Lot number: FC5089) as dose 2, single for covid-19 immunisation.
The patient is expected to deliver one baby(s).
The patient's relevant medical history and concomitant medications were not reported.
Vaccination history included: Comirnaty (DOSE 1), administration date: Jun2021, for covid-19 immunisation.
The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 2021, outcome "unknown", described as "Miscarriage"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 2021, outcome "unknown", described as "disruption of the menstrual cycle/ menstruation lasted 8 days instead of 4 days"; MENSTRUATION DELAYED (non-serious) with onset 2021, outcome "unknown", described as "disruption of the menstrual cycle, this was delayed by 10 days".
The pregnancy resulted in spontaneous abortion.
The fetal outcome is intrauterine death.
The patient underwent the following laboratory tests and procedures: pregnancy test: (28Aug2021) positive, notes: which showed I was about 1-2 weeks pregnant; ultrasound foetal: (2021) embryo appeared to have died, notes: In the 8th week the embryo appeared to have died, but the ultrasound was very noisy; (2021) definitively a threatened miscarriage, notes: Had another ultrasound in the 10th week, in which the embryo and amniotic sac were measured and compared with the first ultrasound, where the conclusion was definitively a threatened miscarriage.
The uterus with contents was clearly visible in the 2nd ultrasound.
Clinical course: It was patient's second vaccination (5 weeks after first vaccination, 0.
3 ML).
During the echo it was seen that the embryo had stopped growing at a pregnancy duration of about 8 weeks, resulting in a miscarriage.
Covid vaccinations took place before pregnancy.
Reporter's Comments: Menstrual cycle disruption and eventually miscarriage.
Received 2nd injection on 30Jul2021.
After this disruption of the menstrual cycle, this was delayed by 10 days and the menstruation lasted 8 days instead of 4 days.
The following month patient found out that she was pregnant, but the exact ovulation date could not be determined, because the injection had disturbed it.
On 28Aug2021, patient did a positive pregnancy test, which showed she was about 1-2 weeks pregnant.
After this, patient hormone balance was still disturbed; she was not able to make a good placenta and the embryo has not managed to implant properly.
The embryo died after 5-6 weeks of pregnancy.
Information about child: Child was not born.
Information about mother and pregnancy: Due date could not be determined exactly (probably around 16Jun2022).
There were no complications during the pregnancy.
Patient works from home behind the PC, so no job risks.
This was her 1st pregnancy.
Other: diagnostic procedures: Patient had an extra term ultrasound in the 10th week.
In the 8th week the embryo appeared to have died, but the ultrasound was very noisy.
Had another ultrasound in the 10th week, in which the embryo and amniotic sac were measured and compared with the first ultrasound, where the conclusion was definitively a threatened miscarriage.
The uterus with contents was clearly visible in the 2nd ultrasound.
Confounding factor: It was reported that patient was prepared for a possible pregnancy and had been trying to eat healthy for a year.
There were no miscarriages in her family, and patient don't use alcohol/drugs/smoking in her daily life (never did).
No follow-up attempts are possible.
No further information is expected.