이상반응 보고
| VAERS ID | 2299585 |
|---|---|
| 성별 | 남성 |
| 나이 | 30세 |
| 주 코드 | |
| 제약회사 | JANSSEN |
| 로트 번호 | |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-12-09 |
| 발병일 | |
| 상태 |
증상
- 상태가 악화됨(Condition aggravated)
- 출혈(Haemorrhage)
- 염증(Inflammation)
- 제품 온도 편차 문제(Product temperature excursion issue)
이환 중 질병
지병
기타 의료
HUMIRA
이전 예방접종
알레르기
임상 검사
증상 상세
BLEEDING; CONDITION AGGRAVATED; INFLAMMATION; HUMIRA PRODUCT TEMPERATURE EXCURSION ISSUE; This spontaneous report received from a consumer via another pharmaceutical company concerned a 30 year old male of an unspecified race and ethnic origin.
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, intramuscular, batch number was not reported) dose was not reported, 1 total administered on 09-DEC-2021 for prophylactic vaccination.
The batch number was not reported.
The Company is unable to perform follow-up to request batch/lot numbers.
Age at time of vaccination 30 years old.
Non-company suspect drugs included: adalimumab (solution for infusion in pre-filled syringe, subcutaneous, batch number was not reported), citrate free, dose, frequency, and therapy dates were not reported was administered for an unspecified indication.
No concomitant medications were reported.
On an unspecified date, the patient experienced bleeding, condition aggravated, inflammation, and humira product temperature excursion issue.
The icepack was completely liquid but was cool to touch even though the little thermometer strip was in or on box received like that from pharmacy with Humira.
The action taken with covid-19 vaccine ad26.
cov2.
s was not applicable; and action taken with adalimumab was not reported.
The patient was recovering from condition aggravated, and inflammation, and the outcome of bleeding and humira product temperature excursion issue was not reported.
This report was serious (Other Medically Important Condition).
; Sender's Comments: V0:20220548649-COVID-19 VACCINE AD26.
COV2.
S-Bleeding.
The event(s) has an unknown/unclear 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.