이상반응 보고

VAERS ID	2590546
성별	여성
나이
주 코드	FR
제약회사	PFIZER\BIONTECH
로트 번호
예방접종 횟수	5
접종일	2022-12-01
발병일	2023-01-12
상태	입원 사망

증상

이환 중 질병

지병

Medical History/Concurrent Conditions: Breast cancer; Breast conserving surgery (No lymph node excision was noted)

기타 의료

ANASTROZOLE

이전 예방접종

알레르기

임상 검사

Test Date: 202209; Test Name: inspection before operation; Result Unstructured Data: Test Result:no metastasis and abnormalities in the lung

증상 상세

Interstitial pneumonia; the patient was aware of dyspnoea sensation; This is a spontaneous report received from a contactable reporter(s) (Physician) from a sales representative and Regulatory Authority.
Regulatory number: v2210003908.
An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.
1 (COMIRNATY RTU FOR BA.
1), in Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation.
The patient's relevant medical history included: "Breast cancer", start date: 05Oct2022, stop date: 05Oct2022; "total removal of the breast cancer right", start date: 05Oct2022, stop date: 05Oct2022, notes: No lymph node excision was noted.
Concomitant medication(s) included: ANASTROZOLE oral taken for breast cancer.
Vaccination history included: Covid-19 vaccine (1st single dose, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (2nd single dose, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (3rd single dose, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (4th single dose, MANUFACTURER UNKNOWN), for COVID-19 immunisation.
The following information was reported: INTERSTITIAL LUNG DISEASE (death, hospitalization) with onset 12Jan2023 at 10:00, outcome "fatal", described as "Interstitial pneumonia"; DYSPNOEA (non-serious), outcome "unknown", described as "the patient was aware of dyspnoea sensation".
The events "interstitial pneumonia" and "the patient was aware of dyspnoea sensation" required physician office visit.
Course of events: On 12Jan2023 at 10:00 (after the vaccination), the patient experienced unspecified event.
On 06Feb2023 (about 2 months later after the vaccination), the outcome of the event was Fatal.
The reporting physician commented as follows: In Sep2022, inspection before operation for breast cancer revealed no metastasis and abnormalities in the lung.
On 05Oct2022, total removal of the breast cancer right was performed.
No lymph node excision was noted.
The patient was orally taking 1 tablet of ANASTROZOLE for breast cancer.
After the fifth dose, the patient was aware of dyspnoea sensation and presented to the emergency outpatient unit at Privacy central hospital and was diagnosed with interstitial pneumonia.
After hospital admission, steroid pulse therapy was performed 4 times in a total.
However, the symptom did not improve.
Since it had been reported that the patient had been well before the vaccination and had shown a clinical course without metastasis and with normal lung filed after operation for breast cancer.
Therefore, the reporter suspected the causality with the vaccination.
The patient's family had strongly unbelievable thoughts.
And hence the reporter reported the case.
This report met the criteria of Interstitial pneumonia.
The reporting physician classified the event as serious (Fatal) and assessed that the event was related to BNT162b2.
Other possible cause of the event such as any other diseases was Interstitial pneumonia during oral administration of ANASTROZOLE was diagnosed.
However, considering the clinical course and the possibility of adverse drug reactions and so on, the causality with mRNA vaccination was suspected.
The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.
1 has been requested and will be submitted if and when received.
; Reported Cause(s) of Death: Interstitial pneumonia