이상반응 보고
| VAERS ID | 2296238 |
|---|---|
| 성별 | 여성 |
| 나이 | 27세 |
| 주 코드 | FR |
| 제약회사 | JANSSEN |
| 로트 번호 | XG426 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-08-21 |
| 발병일 | 2021-08-21 |
| 상태 | 후유증 |
증상
- 발열(Pyrexia)
- 두통(Headache)
- 메스꺼움(Nausea)
- 현지 반응(Local reaction)
- 근육통(Myalgia)
- 근육 경련(Muscle spasms)
- 신경통(Neuralgia)
- 체온(Body temperature)
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임상 검사
Test Date: 20210821; Test Name: Body temperature; Result Unstructured Data: greater than 38 C
증상 상세
SEVERE LOCAL REACTION; SEVERE LOCAL REACTION BEYOND NEAREST JOINT; NERVE PAIN; MUSCLE SPASMS; FEVER GREATER THAN 38 C; ICE PICK HEADACHE; MUSCLE ACHE; NAUSEA; This spontaneous report received from a consumer via a Regulatory Authority, (Health Products Regulatory Authority) (ZA-SAHPRA-300056819) concerned a 27 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.
The patient received covid-19 vaccine ad26.
cov2.
s (suspension for injection, route of admin not reported, batch number: XG426 expiry: UNKNOWN) dose was not reported, 1 total administered on 21-AUG-2021 for an unspecified indication.
The age at time of vaccination was 27 years old.
No concomitant medications were reported.
On 21-AUG-2021, the patient experienced severe local reaction, severe local reaction beyond nearest joint, muscle spasms, nerve pain, fever greater than 38 degrees Celsius (C), ice pick headache, muscle ache, and nausea.
Laboratory data included: Body temperature (NR: not provided) greater than 38 C.
The latency (reaction first time) for severe local reaction, severe local reaction beyond nearest joint and fever greater than 38 C was reported to be four hours.
The action taken with covid-19 vaccine ad26.
cov2.
s was not applicable.
The patient was recovering from nausea, and had not recovered from severe local reaction, fever greater than 38 c, ice pick headache, muscle spasms, nerve pain, muscle ache, and severe local reaction beyond nearest joint.
This report was serious (Disability Or Permanent Damage).
; Sender's Comments: V0: 20220546128-Covid-19 vaccine ad26.
cov2.
s- severe local reaction, severe local reaction beyond nearest joint, muscle spasms, nerve pain.
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.
20220546128-Covid-19 vaccine ad26.
cov2.
s- Nausea, fever greater than 38 c, ice pick headache, muscle ache.
This event(s) is labeled per RSI and is therefore considered potentially related.