이상반응 보고
| VAERS ID | 1521529 |
|---|---|
| 성별 | 남성 |
| 나이 | 74세 |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-06-24 |
| 발병일 | 2021-06-25 |
| 상태 | 입원 사망 |
증상
- 혈액 검사(Blood test)
- 요로 감염(Urinary tract infection)
- 컴퓨터 단층 촬영(Computerised tomogram)
- 소변 분석(Urine analysis)
- 혈액 배양(Blood culture)
- 배양 소변(Culture urine)
- 심근 경색증(Myocardial infarction)
- 혈압 측정(Blood pressure measurement)
- 체온(Body temperature)
- 신장 기능 검사(Renal function test)
- 패혈성 쇼크(Septic shock)
- 파종 성 혈관 내 응고(Disseminated intravascular coagulation)
- 장 허혈(Intestinal ischaemia)
- 간 괴사(Hepatic necrosis)
- 급성 신우신염(Pyelonephritis acute)
- 비장 감염(Splenic infection)
- 신장 이식편 감염(Renal graft infection)
이환 중 질병
Immunosuppressant drug therapy
지병
Medical History/Concurrent Conditions: Living donor renal transplant
기타 의료
이전 예방접종
알레르기
임상 검사
Test Date: 20210628; Test Name: blood culture; Result Unstructured Data: Test Result:gram-positive coccus was detected; Comments: gram-positive coccus was detected on the blood culture and the urine culture (later, it was revealed as methicillin-resistant Staphylococcus aureus [MRSA]); Test Date: 20210627; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210623; Test Name: blood examination; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210627; Test Name: blood examination; Result Unstructured Data: Test Result:significant inflammatory reaction; Test Date: 20210625; Test Name: Body temperature; Result Unstructured Data: Test Result:39s Centigrade; Comments: pyrexia of 39s degrees Celsius; Test Date: 20210627; Test Name: CT; Result Unstructured Data: Test Result:no obvious cause of fever; Test Date: 20210628; Test Name: urine culture; Result Unstructured Data: Test Result:gram-positive coccus was detected; Comments: gram-positive coccus was detected on the blood culture and the urine culture (later, it was revealed as methicillin-resistant Staphylococcus aureus [MRSA]); Test Date: 20210627; Test Name: renal function; Result Unstructured Data: Test Result:aggravation; Test Date: 20210623; Test Name: urine examinations; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210627; Test Name: urine examinations; Result Unstructured Data: Test Result:pyuria and bacteriuria
증상 상세
Septic shock; urinary tract infection (pyelonephritis acute); urinary tract infection (pyelonephritis acute); haemorrhage and white shadows on the transplanted kidney, and infection was suspected, which was considered as primary lesion; map-like macula was observed in the liver, and necrosis was suspected; intestinal ischaemia; infectious spleen; myocardial infarction suspected; disseminated intravascular coagulation; This is a spontaneous report from a contactable physician received from the Regulatory Authority.
Regulatory authority report number is v21120430.
A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 24Jun2021 at 74-year-old (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation.
Medical history included renal transplant, ongoing immunosuppressant drug therapy.
The patient was a 74-year-old (at vaccination) male.
Since the patient was after living donor renal transplant, he was receiving immunosuppressant drug therapy.
She had concomitant Therapy.
The patient experienced septic shock on 27Jun2021 with fatal outcome, urinary tract infection (pyelonephritis acute) on 25Jun2021 with fatal outcome, disseminated intravascular coagulation on 27Jun2021 with outcome of unknown, haemorrhage and white shadows on the transplanted kidney, and infection was suspected, which was considered as primary lesion , map-like macula was observed in the liver, and necrosis was suspected, intestinal ischaemia, infectious spleen, and myocardial infarction suspected, all on unknown date with unknown outcome.
The patient was hospitalized for septic shock, urinary tract infection (pyelonephritis acute) from 27Jun2021 to an unknown date.
The patient died on 29Jun2021.
Treatment received for all events.
On 24Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2.
On 25Jun2021 (1 day after the vaccination), the patient experienced urinary tract infection (pyelonephritis acute).
On 27Jun2021 (3 days after the vaccination), the patient experienced septic shock and was admitted to the hospital.
On 29Jun2021 (5 days after the vaccination), the outcome of the events was fatal.
The course of the event was as follows: On 23Jun2021, when the patient was usually examined at the outpatient department, the blood and urine examinations showed no abnormalities.
On 24Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination.
On 25Jun2021 (one day after vaccination), the patient had pyrexia of 39s degrees Celsius.
On 27Jun2021 (3 days after vaccination), since the pyrexia persisted, the patient visited the reporting hospital.
Diarrhoea and vomiting were noted as other symptoms.
The blood examination showed significant inflammatory reaction.
Since aggravation of renal function was observed, and pyuria and bacteriuria were noted, the patient was diagnosed with urinary tract infection (pyelonephritis acute).
CT showed no obvious cause of fever.
The patient was admitted to the hospital, and a drip infusion of an antibiotic and fluid replacement was performed; however, blood pressure decreased was noted.
It was considered that the patient had septic shock, which required catecholamine support.
The patient also had disseminated intravascular coagulation (DIC).
On 28Jun2021 (4 days after vaccination), gram-positive coccus was detected on the blood culture and the urine culture (later, it was revealed as methicillin-resistant Staphylococcus aureus [MRSA]), and an antibiotic was added; however, the condition was aggravated.
The patient was admitted to the cardiac care unit (CCU), and tracheal intubation was performed, and hemodialysis therapy was initiated.
However, the condition did not improve.
On 29Jun2021 (5 days after vaccination), the patient was confirmed to die.
A pathologic autopsy (macroscopic) showed haemorrhage and white shadows on the transplanted kidney, and infection was suspected, which was considered as primary lesion.
In addition, map-like macula was observed in the liver, and necrosis was suspected, and intestinal ischaemia was also noted.
In addition, infectious spleen and myocardial infarction suspected were also noted.
The reporting physician classified the septic shock as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable.
Other possible cause of the event such as any other diseases was pyelonephritis acute.
The reporting physician commented as follows: It was considered that the cause of death was septic shock, and cause of septic shock was pyelonephritis acute.
It was impossible to judge whether the vaccination was involved or not; however, the timing of the event was immediately after the vaccination, and thus, this case was reported.
The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
; Reported Cause(s) of Death: Septic shock; urinary tract infection (pyelonephritis acute); urinary tract infection (pyelonephritis acute); Autopsy-determined Cause(s) of Death: intestinal ischaemia; infectious spleen; myocardial infarction suspected; haemorrhage and white shadows on the transplanted kidney, and infection was suspected, which was considered as primary lesion; map-like macula was observed in the liver, and ne