이상반응 보고
| VAERS ID | 2296232 |
|---|---|
| 성별 | 여성 |
| 나이 | 26세 |
| 주 코드 | FR |
| 제약회사 | JANSSEN |
| 로트 번호 | |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-10-01 |
| 발병일 | 2021-10-02 |
| 상태 |
증상
- 심한 월경 출혈(Heavy menstrual bleeding)
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증상 상세
BLEEDING MENSTRUAL HEAVY; This spontaneous report received from a health care professional via a Regulatory Authority, (RA) (ZA-SAHPRA-300060903) concerned a 26 year old female of an unspecified race and ethnicity.
The patient's height, and weight were not reported.
No past medical history or concurrent conditions were reported.
On an unspecified date, the patient previously received covid-19 vaccine from an unspecified manufacturer (dose number in series: 1) (form of admin, route of admin, and batch number were not reported, expiry: unknown), dose was not reported, administered for an unspecified indication.
It was unknown whether patient had any adverse events covid-19 vaccine from an unspecified manufacturer (dose number in series: 1).
The patient received covid-19 vaccine ad26.
cov2.
s (dose number in series: 2) (suspension for injection, route of admin, and batch number were not reported, expiry: 30-JUN-2022) dose was not reported, 1 total administered on 01-OCT-2021 for an unspecified indication.
The batch number was not reported.
The Company is unable to perform follow-up to request batch/lot numbers.
The age at time of vaccination was 26 years old.
The diluent included: normal saline (Batch number: Ttttttt, expiry: 30-JUL-2022, reconstitution time: 01-SEP-2021 11:00).
No concomitant medications were reported.
On 02-OCT-2021, the patient experienced bleeding menstrual heavy (dose number in series:2).
On 19-OCT-2021, the patient visited the clinic and was given an unspecified injection and pills to stop the bleeding which was of no help and instead she was bleeding with dark clots.
The action taken with covid-19 vaccine ad26.
cov2.
s was not applicable.
The patient had not recovered from bleeding menstrual heavy.
This report was serious (Other Medically Important Condition).
; Sender's Comments: V0: 20220544428- covid-19 vaccine ad26.
cov2.
s - bleeding menstrual heavy.
The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility.
There is no information on any other factors potentially associated with the event(s).
Therefore, this event(s) is considered unassessable.