이상반응 보고
| VAERS ID | 1738470 |
|---|---|
| 성별 | 여성 |
| 나이 | 27세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FF0688 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-07-30 |
| 발병일 | 2021-07-30 |
| 상태 | 입원 |
증상
- 비출혈(Epistaxis)
- 혀 깨물기(Tongue biting)
- 임신 중 모성 노출(Maternal exposure during pregnancy)
- 간질(Epilepsy)
- 비강 손상(Nasal injury)
- 코 기형(Nose deformity)
이환 중 질병
Epilepsy (crisis-free since 2019)
지병
기타 의료
Pfizer, Inc. EUA 027034
이전 예방접종
알레르기
임상 검사
증상 상세
Epileptic fit; Nose wound and deformity; Nose wound and deformity; Epistaxis; Tongue biting; Maternal Exposure During Pregnancy, second trimester; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-NY20213997.
A 27-year-old female patient received bnt162b2 (COMIRNATY), via intramuscular administered in Arm Left on 30Jul2021 at age of 27-year-old (Batch/Lot Number: FF0688) as dose 1, single, for COVID-19 immunization.
Medical history included ongoing epilepsy (crisis-free since 2019).
Concomitant medication included ongoing lamotrigine (LAMICTAL) taken for epilepsy (300 mg in the morning).
The patient experienced epileptic fit first episode on 30Jul2021 and second episode on 12Aug2021, maternal exposure during pregnancy, second trimester on 30Jul2021, tongue biting on 31Jul2021, nose wound and deformity, epistaxis on 12Aug2021.
The event epileptic fit were serious for hospitalization, medically significant.
It was reported that two epileptic seizures in a 27 year old woman, 6 months pregnant, with a history of epilepsy, after the first vaccination against COVID 19 by bnt162b2.
The first attack occurred on the day of the vaccination and the second attack 14 days after the injection.
Hospitalization of the patient.
Patient recovered with sequelae on the date of the declaration.
The event epileptic fit first episode was resolved with sequelae on 30Jul2021, the event epileptic fit second episode was resolved with sequelae on 12Aug2021.
The outcome of tongue biting, nose wound and deformity, epistaxis was unknown.
Reporter comment: Two epileptic seizures in a 27 year old female, 6 months pregnant, with a medical history of epilepsy, after the first vaccination against COVID 19 with COMIRNATY (batch FF0688).
The first seizure had onset on the day of the vaccination and the second seizure fourteen days after the injection.
Hospitalisation of the female patient.
Female patient recovered with sequelae at the date of the declaration.
Sender comment: Case Summary: File from the Reporting Portal No.
20210825144258171.
27 year old female, 6 months pregnant, with a medical history of epilepsy.
Current treatment: LAMICTAL (lamotrigine) (300 mg in the morning).
On 30Jul2021, first vaccination against COVID-19 with COMIRNATY (batch FF0688) intramuscularly in the left arm.
On 30Jul2021, onset of a new epileptic seizure lasting less than one minute.
Tongue biting on 31Jul2021, female patient was hospitalized.
The female patient returned home.
On 12Aug2021, onset of an epileptic seizure.
She was conscious and oriented.
Nose wound and deformity.
Epistaxis.
Sick leave was prescribed.
Female patient recovered with sequelae at the date of the declaration.
Conclusion: two epileptic seizures in a 27 year old female, 6 months pregnant, with a medical history of epilepsy, after the first vaccination against COVID 19 with COMIRNATY (batch FF0688).
The first seizure had onset on the day of the vaccination and the second seizure fourteen days after the injection.
Hospitalisation of the female patient.
Female patient recovered with sequelae at the date of the declaration.
Note: Accountability without prejudice to the elements of investigations that could be carried out as part of legal or amicable compensation procedures.
No follow up attempts are needed.
No further information is expected.
; Reporter's Comments: .
Two epileptic seizures in a 27 year old female, 6 months pregnant, with a medical history of epilepsy, after the first vaccination against COVID 19 with COMIRNATY (batch FF0688).
The first seizure had onset on the day of the vaccination and the second seizure fourteen days after the injection.
Hospitalisation of the female patient.
Female patient recovered with sequelae at the date of the declaration.