이상반응 보고
| VAERS ID | 1575866 |
|---|---|
| 성별 | 남성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-07-28 |
| 발병일 | 2021-07-01 |
| 상태 |
증상
- 발열(Pyrexia)
- 오한(Chills)
- 혼수(Lethargy)
- 체온(Body temperature)
- 모유를 통한 노출(Exposure via breast milk)
이환 중 질병
지병
Medical History/Concurrent Conditions: Teething pain.
기타 의료
IBUPROFEN.
이전 예방접종
알레르기
임상 검사
Test Date: 202107; Test Name: Body temperature; Result Unstructured Data: Test Result:39.
3 Centigrade; Comments: high
증상 상세
Fever/high temperature/feverish/high temperature of 39.
3 C; Patient is a breastfed baby; shivery; lethargic; This is a spontaneous report from a contactable consumer (patient's mother).
This is the first report of two reports.
The first report is the report received from the Regulatory Authority.
The regulatory authority report number is GB-MHRA-WEBCOVID-202107311604254610-6BZIT, Safety Report Unique Identifier GB-MHRA-ADR 25737273.
This consumer reported information for both mother and fetus/baby.
This is the baby report.
A 1-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 transmammary on 28Jul2021 (Lot number was not known) as dose 2, single for COVID-19 immunisation.
Medical history included teething pain.
Patient has not had symptoms associated with COVID-19.
Not had a COVID-19 test.
Concomitant medication included ibuprofen taken for teething pain from 29Jul2021 to 31Jul2021.
The patient experienced shivery, lethargic, high temperature, feverish on an unspecified date; and fever on 29Jul2021.
Clinical course reported: patient was a breastfed baby who was previously well, but within 12 hours (Jul2021) of the mother receiving the vaccine and breastfeeding child, became lethargic, shivery and feverish with a high temperature of 39.
3 C.
This went on for 48 hours and was not reactive to paracetamol or ibuprofen.
Patient has not tested positive for COVID-19 since having the vaccine.
Patient is not enrolled in clinical trial.
The outcome of the events fever was recovering; and for other events was unknown.
Regulatory authority assessed the events as serious: medically significant.
No follow-up attempts are possible; information about lot/batch number cannot be obtained.
; Sender's Comments: Linked Report(s) : GB-PFIZER INC-202100985608 Maternal Case