이상반응 보고
| VAERS ID | 2222210 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | ACB8491 |
| 예방접종 횟수 | 3 |
| 접종일 | 2021-12-23 |
| 발병일 | 2022-02-12 |
| 상태 | 사망 |
증상
- 고혈압(Hypertension)
- 혈압 변동(Blood pressure fluctuation)
- 급성 심근경색(Acute myocardial infarction)
- 혈압 측정(Blood pressure measurement)
이환 중 질병
Atrial fibrillation (previous atrial fibrillation treated with beta-blockers and anticoagulants); Hypertension arterial (treated without effect hypertension in therapy with hypotensive drugs).
지병
Medical History/Concurrent Conditions: Heart disease, unspecified; Hypertensive episodes
기타 의료
Rytmonorm; Pradaxa; Cardura; Bonviva [Ibandronate Sodium]; Atenolol; Micardis; Eutirox; Pantorc; Captopril
이전 예방접종
알레르기
임상 검사
Test Name: blood pressure; Result Unstructured Data: Test Result:200 mmHg; Comments: maximum pressure peaks; Test Name: blood pressure; Result Unstructured Data: Test Result:80 mmHg; Comments: sudden changes and the maximum went from 80 to 200 mmHg in less than 24 hours.
증상 상세
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB.
Regulatory number: IT-MINISAL02-857574 (RA).
An 88-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 23Dec2021 (Lot number: ACB8491) as dose 3 (booster), single for Covid-19 immunisation.
Relevant medical history included: "Hypertension arterial" (ongoing), notes: treated without effect, hypertension in therapy with hypotensive drugs; "Atrial fibrillation" (ongoing), notes: previous atrial fibrillation treated with beta-blockers and anticoagulants; "Heart disease" (unspecified if ongoing); "Hypertensive episodes" (unspecified if ongoing).
Concomitant medication(s) included: RYTMONORM; PRADAXA; CARDURA, start date: Mar2021; BONVIVA [IBANDRONATE SODIUM]; ATENOLOL; MICARDIS; EUTIROX; PANTORC; CAPTOPRIL.
Vaccination history included: Comirnaty (1st dose, batch/lot number: ET1831, left deltoid), administration date: 17Mar2021, for Covid-19 immunization, reaction(s): "Blood pressure high"; Comirnaty (2nd dose, batch/lot number: EW2246, left deltoid), administration date: 07Apr2021, for Covid-19 immunization.
Remodulation and variation by the cardiologist who was treating her of the therapy for hypertension without effectiveness.
Impact on quality of life (10/10).
Because of the extremely high pressure that the patient had not been able to lower significantly despite Captopril tablets, taken as prescribed by her cardiologist.
The medications she had been taking for several years were: Rytmonorm, Atenolol, Micardis, Pradaxa, Eutirox, Pantorc, Bonviva.
In Mar2021 Cardura was added to the listed therapy, because of these hypertensive peaks; when the problem had returned it was eliminated and then prescribed again.
In Jan2022, for the same symptoms, concomitant therapies were reported.
The patient suffered from atrial fibrillation for several years.
The therapy had stabilized the situation for at least a couple of years: she had not had any more crises.
She also suffered from hypertension and even before the first vaccination she had had sporadic episodes of blood pressure peaks, always returned with the intake of Captopril.
These peaks have become almost daily with particularly high values (even over 200 mmHg) after the first vaccination and not always returned, despite the assumption of Captopril tablets, in fact sometimes she had called the doctor, as in the cases reported and attached.
Cardura was added to the usual therapy, to be increased when needed.
The following information was reported: ACUTE MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "Death from Acute myocardial infarction"; HYPERTENSION (death) with onset 12Feb2022, outcome "fatal", described as "after a period of worsening of pressure changes (maximum pressure peaks over 200 mm / Hg).
"; BLOOD PRESSURE FLUCTUATION (death), outcome "fatal", described as "the blood pressure underwent sudden changes and the maximum went from 80 to 200 mmHg in less than 24 hours".
The events "death from acute myocardial infarction", "after a period of worsening of pressure changes (maximum pressure peaks over 200 mm / hg).
" and "the blood pressure underwent sudden changes and the maximum went from 80 to 200 mmhg in less than 24 hours" were evaluated at the emergency room visit.
The patient underwent the following laboratory tests and procedures: blood pressure measurement: 200 mmHg, notes: maximum pressure peaks; 80 mmHg, notes: sudden changes and the maximum went from 80 to 200 mmHg in less than 24 hours.
Therapeutic measures were taken as a result of acute myocardial infarction, hypertension, blood pressure fluctuation.
The patient date of death was 12Feb2022.
The reported cause of death was acute myocardial infarction, hypertension, blood pressure fluctuation.
It was not reported if an autopsy was performed.
With the new therapy, the blood pressure underwent sudden changes and the maximum went from 80 to 200 mmHg in less than 24 hours, other times it persisted, always despite the Captopril, at very high values.
The problem returned after about three months.
It has reappeared in the manner described above a few weeks after the third dose of the vaccine until the death occurred on 12Feb2022.
No follow-up attempts are possible.
No further information is expected.
Sender's Comments: Linked Report(s): IT-PFIZER INC-202200529470 The same patient/reporter, different dose/ events; Reported Cause(s) of Death: Change in blood pressure; Acute myocardial infarction; Uncontrolled hypertension.