이상반응 보고
| VAERS ID | 2567082 |
|---|---|
| 성별 | 여성 |
| 나이 | 79세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FA2453 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-06-10 |
| 발병일 | 2021-06-10 |
| 상태 | 사망 |
증상
- 발열(Pyrexia)
- 혈액 검사(Blood test)
- 식욕 감소(Decreased appetite)
- 섭식 장애(Feeding disorder)
- 체온(Body temperature)
- 심부전(Cardiac failure)
- Mania(Mania)
- 뼈로의 전이(Metastases to bone)
- 간 기능 이상(Hepatic function abnormal)
- 유방암(Breast cancer)
이환 중 질병
지병
Medical History/Concurrent Conditions: Contrast media allergy; Drug allergy
기타 의료
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임상 검사
Test Date: 20210618; Test Name: Blood test; Result Unstructured Data: Test Result:aggravated hepatic function and aggravated cardiac; Comments: failure; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:36.
1 Centigrade; Comments: before vaccination
증상 상세
Breast cancer/in a terminal state with breast cancer and metastases to bone; metastases to bone/in a terminal state with breast cancer and metastases to bone; aggravated cardiac failure; aggravated hepatic function; unable to take food; prominent manic state; low grade fever; appetite impaired/prominent appetite impaired; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority.
Regulatory number: v2210003653.
A 79-year-old female patient received BNT162b2 (COMIRNATY), on 10Jun2021 as dose 1, single (Lot number: FA2453, Expiration Date: 31Aug2021) at the age of 79 years for covid-19 immunisation.
The patient's relevant medical history included: "Allergic reactions to pyrazolone drugs and contrast dye" (unspecified if ongoing); "Allergic reactions to pyrazolone drugs and contrast dye" (unspecified if ongoing).
The patient took concomitant medications.
The following information was reported: DECREASED APPETITE (non-serious) with onset 10Jun2021, outcome "unknown", described as "appetite impaired/prominent appetite impaired"; PYREXIA (non-serious) with onset 10Jun2021, outcome "unknown", described as "low grade fever"; CARDIAC FAILURE (death, medically significant) with onset 18Jun2021, outcome "fatal", described as "aggravated cardiac failure"; HEPATIC FUNCTION ABNORMAL (death) with onset 18Jun2021, outcome "fatal", described as "aggravated hepatic function"; MANIA (non-serious) with onset 18Jun2021, outcome "unknown", described as "prominent manic state"; FEEDING DISORDER (non-serious) with onset 18Jun2021, outcome "unknown", described as "unable to take food"; BREAST CANCER (death, medically significant), outcome "fatal", described as "Breast cancer/in a terminal state with breast cancer and metastases to bone"; METASTASES TO BONE (death, medically significant), outcome "fatal", described as "metastases to bone/in a terminal state with breast cancer and metastases to bone".
The patient underwent the following laboratory tests and procedures: Blood test: (18Jun2021) aggravated hepatic function and aggravated cardiac, notes: failure; Body temperature: (10Jun2021) 36.
1 Centigrade, notes: before vaccination.
The patient date of death was unknown.
Reported cause of death: "Breast cancer/in a terminal state with breast cancer and metastases to bone", "metastases to bone/in a terminal state with breast cancer and metastases to bone", "aggravated cardiac failure", "aggravated hepatic function".
Clinical course:The patient had allergic reactions to pyrazolone drugs and contrast dye.
Under treatment with oral anticoagulation drugs.
On 10Jun2021 in the afternoon(the day of vaccination), the patient received the first dose of BNT162b2(COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization.
On 18Jun2021(as reported)(8 days after the vaccination), the patient experienced events.
The outcome of the event was fatal.
The course of the event was as follows: On 10Jun2021, the patient had low grade fever and appetite impaired after receiving the first dose of coronavirus vaccine.
On 18Jun2021, she was unable to take food, and showed prominent manic state.
Blood test revealed aggravated hepatic function and aggravated cardiac failure.
The reporting physician assessed that the causality between the event and BNT162b2 as unassessable.
Other possible cause(s) of the event such as any other diseases were breast cancer, metastases to bone.
The reporting physician commented as follows: The patient showed prominent appetite impaired after coronavirus vaccination.
However, she was in a terminal state with breast cancer and metastases to bone, and thus it is considered that the death was caused by breast cancer and metastases to bone.
; Reported Cause(s) of Death: Breast cancer/in a terminal state with breast cancer and metastases to bone; metastases to bone/in a terminal state with breast cancer and metastases to bone; aggravated cardiac failure; aggravated hepatic function