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VAERS ID 2558974
성별 여성
나이 58세
주 코드 FR
제약회사 MODERNA
로트 번호
예방접종 횟수 2
접종일 2022-01-19
발병일 2022-02-01
상태
증상
  • 두드러기 만성(Urticaria chronic)

이환 중 질병

지병

Medical History/Concurrent Conditions: Allergy (allergies); COVID-19

기타 의료

이전 예방접종

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임상 검사

증상 상세

Chronic urticaria; This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA CHRONIC (Chronic urticaria) in a 58-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 prophylaxis.
The patient's past medical history included COVID-19.
Concurrent medical conditions included Allergy (allergies).
On 19-Jan-2022, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form.
On 01-Feb-2022, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced URTICARIA CHRONIC (Chronic urticaria) (seriousness criterion medically significant).
At the time of the report, URTICARIA CHRONIC (Chronic urticaria) had not resolved.
No concomitant medications were reported.
Treatment information was not provided.
Sender's comments: The case was serious and unlabelled.
Due to temporal relationship and the known safety profile of the vaccine, the causality was assessed as possible.
Company Comment: This is a regulatory case concerning a 58 year-old, female patient with a history of Hypersensitivity, who experienced the serious (due to medically significant) unexpected, event of Urticaria chronic, which occurred 13 days after the second dose of mRNA-1273 vaccine.
The outcome was reported as not recovered.
The mentioned medical history remains as a confounder.
The company causality for the event is considered as related to the vaccine.
No further clinical information was available for medical review.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Event´s seriousness assessed as reported.