이상반응 보고
| VAERS ID | 2549617 |
|---|---|
| 성별 | 남성 |
| 나이 | 8세 |
| 주 코드 | NJ |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | GK1657 |
| 예방접종 횟수 | 4 |
| 접종일 | 2022-12-15 |
| 발병일 | 2022-12-17 |
| 상태 | 입원 후유증 회복 |
증상
- 일과성 허혈 발작(Transient ischaemic attack)
- 폴리 메라 제 연쇠 반응(Polymerase chain reaction)
이환 중 질병
지병
Medical History/Concurrent Conditions: COVID-19
기타 의료
이전 예방접종
알레르기
임상 검사
Test Date: 20221223; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab
증상 상세
Three TIA events (17Dec2022; 20Dec2022; 24Dec2022) + several small acute infarcts in Lt posterior Cerebellum.
Additional acute infarct in lt occipital subcortical white matter.
; This is a spontaneous report received from a contactable reporter(s) (Physician).
An 8-year-old male patient received BNT162b2, BNT162b2 omi ba.
4-5 (BNT162B2, BNT162B2 OMI BA.
4-5), on 15Dec2022 at 12:00 as dose 4 (booster), single (Lot number: GK1657) at the age of 8 years intramuscular, in left arm for covid-19 immunisation.
The patient's relevant medical history included: "COVID-19" (unspecified if ongoing).
The patient's concomitant medications were not reported.
Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FL2757, Location of injection: Left arm, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 16Sep2022, when the patient was 8-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EK5127, Location of injection: Left arm, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 15Dec2021, when the patient was 7-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EK9127, Location of injection: Left arm, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 18Nov2021, when the patient was 7-year-old, for COVID-19 Immunization.
The following information was reported: TRANSIENT ISCHAEMIC ATTACK (hospitalization, disability) with onset 17Dec2022 at 08:00, outcome "recovered" (Dec2022), described as "Three TIA events (17Dec2022; 20Dec2022; 24Dec2022) + several small acute infarcts in Lt posterior Cerebellum.
Additional acute infarct in lt occipital subcortical white matter.
".
The patient was hospitalized for transient ischaemic attack (hospitalization duration: 2 day(s)).
The event "three tia events (17dec2022; 20dec2022; 24dec2022) + several small acute infarcts in lt posterior cerebellum.
additional acute infarct in lt occipital subcortical white matter.
" required physician office visit and emergency room visit.
The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (23Dec2022) Negative, notes: Nasal Swab.
Therapeutic measures were taken as a result of transient ischaemic attack.
Clinical course: The patient didn't receive any other vaccine in four weeks.
It was unknown if the patient received other medications in two weeks.
The patient received T.
Aspirin 81 mg da as a treatment of AE.
The patient had no known allergies.
It was reported that the other medical history was none.
; Sender's Comments: Based on the temporal relationship, the association between the event transient ischemic attack with BNT162B2, BNT162B2 OMI BA.
4-5 can not be fully excluded.
The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.