이상반응 보고

VAERS ID 1892455
성별 여성
나이 93세
주 코드 FR
제약회사 PFIZER\BIONTECH
로트 번호
예방접종 횟수
접종일 2021-06-24
발병일
상태 사망
증상
  • 뇌병증(Encephalopathy)
  • 활력 징후 측정(Vital signs measurement)
  • 대사성 뇌병증(Metabolic encephalopathy)
  • 패혈성 뇌병증(Septic encephalopathy)
  • 뇌혈관 장애(Cerebrovascular disorder)

이환 중 질병

지병

기타 의료

KEPPRA [LEVETIRACETAM]

이전 예방접종

알레르기

임상 검사

Test Date: 20210705; Test Name: VS; Result Unstructured Data: Test Result:120/60, 95, 16, 98%

증상 상세

Encephalopathy; CVD; Metabolic/Septic Encephalopathy; Septic Encephalopathy; This is a spontaneous report from a contactable healthcare professional.
This is a report received from the Regulatory Authority.
Regulatory authority report number is PH-PHFDA-300116602.
A 93-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular on 24Jun2021 (Batch/Lot number was not reported) (at the age of 93 years old) as dose number unknown, single for COVID-19 immunization.
The patient's medical history was not reported.
Concomitant medications included levetiracetam (KEPPRA) taken for an unspecified indication, start and stop date were not reported.
It was reported that on 04Jul2021 1 day, the patient's son noted increasing sleeping time.
Same day patient was given levetiracetam (unknown dosage, twice a day (BID)).
On 05Jul2021 1141H, the patient was brought to ER, patient was asleep, open eyes to pain, mumble incomprehensible sound; often breath Sounds (-) bipedal edema; VS:120/60, 95, 16, 98%.
On 05Jul2021 1448H, patient's son decided to bring the patient home (discharge against medical advice).
Patient was prescribed "Home Medications & Feeding Prescription: AUGMENTIN SYRUP 250mg/mL, 20 mL BID, Ensure HMB 4 scoopsin 150 mL H20 every 6 hours, Flush with 50 mL H20 pre and post feeding".
Upon continuous monitoring & Surveillance: Patient was declared dead on 12Jul2021.
Cause of death: Encephalopathy prob sec to CVD, Metabolic/Septic Encephalopathy, Leviteracetam side effect (as reported).
It was not reported if an autopsy was performed.
No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No further information is expected.
; Reported Cause(s) of Death: Encephalopathy; CVD; Metabolic/Septic Encephalopathy; Septic Encephalopathy