Adverse Event Reporting
| VAERS ID | 1526683 |
|---|---|
| Gender | Female |
| Age | 75 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | |
| Vaccinated | 2021-07-07 |
| Onset | 2021-07-07 |
| Condition | Died |
Symptoms
- Electrocardiogram
- Troponin
- Angiogram
- Blood creatinine
- Cardiac arrest
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Appendectomy; Atrial fibrillation; Cholecystectomy; Chronic renal insufficiency; Claudication; Coronary stent user; Diphtheria; Dyslipidaemia; Ex-tobacco user; Horton's disease; Hypertension arterial (HTA); Ischaemic heart disease (ACS (acute coronary syndrome) ST- ischemic heart disease in the lower territory in 2011); Lower urinary tract infection; Lung edema; Peripheral arterial disease; Total knee replacement; Type 2 diabetes mellitus; Umbilical hernia repair
Other Medications
ELIQUIS; LANSOPRAZOLE; ATORVASTATIN; AMLODIPINE; AMIODARONE; BISOPROLOL; RAMIPRIL; FUROSEMIDE; DIFFU K; PAROXETINE; ZYMAD; BROMAZEPAM; TOVIAZ; DITROPAN
Previous Vaccinations
Allergies
Laboratory Data
Test Name: coronary angiography; Result Unstructured Data: Test Result:intra-stent thrombosis of the right coronary.
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artery balloon dilation then loading dose + heparin therapy + cangrelor + tirofiban; Test Name: baseline creatinemia; Result Unstructured Data: Test Result:158 umol/l; Test Name: ECG; Result Unstructured Data: Test Result:no clear signs of ischemia; Test Name: Troponinemia; Result Unstructured Data: Test Result:0.
13 ng/ml
Write-up
Arrest cardiac; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number FR-AFSSAPS-PP20211057.
A 75-years-old female patient received bnt162b2 (COMIRNATY), intramuscularly on 07Jul2021 at age of 75 years old (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, single for covid-19 immunisation.
Medical history included weaned tobacco, Hypertension arterial (HTA), Dyslipidemia, Type 2 diabetes since 2014, SCA ST- ischemic heart disease in the lower territory in 2011, bare stent on the right coronary artery, Peripheral arterial disease (PAD) known since 2017 with vascular claudication on exertion, Chronic renal insufficiency (CRI) on probable nephroangiosclerosis with baseline creatinemia at 158 micro-mol / L, Atypical Horton's disease with thoracic aortitis diagnosed in 2015, Repeated lower urinary tract infections, Diphtheria at 3 years, Total knee replacement Sep2020, Appendectomy in 1963, Umbilical hernia treatment in 1995, Cholecystectomy in 2000, ALE (acute lung edema) on transition to rapid atrial fibrillation, minimal ischemic part probable in Apr2021.
Concomitant medication(s) included apixaban (ELIQUIS); lansoprazole; atorvastatin; amlodipine; amiodarone; bisoprolol; ramipril; furosemide; potassium chloride (DIFFU K); paroxetine; colecalciferol (ZYMAD); bromazepam; fesoterodine fumarate (TOVIAZ); oxybutynin hydrochloride (DITROPAN), all taken for an unspecified indication, start and stop date were not reported.
Patient presenting with cardiac arrest due to intrastent coronary stenosis immediately after (5 min) on 07Jul2021 of a COVID 19 vaccine booster.
The same day, immediately after the injection (delay = 5 min), discomfort without prodrome then cardio-respiratory arrest quickly recovered after injection of adrenaline (1 mg) and the installation of a DSA (1 shock delivered initially)On 12Jul2021, the patient died of Multiple organ failure (multivisceral complications) and massive hemoptysis secondary to cardiogenic and vasoplegic shock.
Discussion/conclusion of our analysis: Chronological, semiological and bibliographical data are not very suggestive of the role of vaccination against covid19 in the occurrence of this intrastent thrombosis of the right coronary artery in this polyvascular context.
However, the very short time between the event and the injection (5 min) does not formally rule out the participation (coincidence?) Of the vaccination as a factor that may have favored this intra-stent thrombosis complicated by cardiac arrest.
(arterial hypotension?).
The patient underwent lab tests and procedures which included Electrocardiogram (ECG): no clear signs of ischemia, Troponinemia: 0.
13 ng / mL, Coronary angiography: intra-stent thrombosis of the right coronary artery balloon dilation then loading dose + heparin therapy + cangrelor + tirofiban, baseline creatinemia at 158 micro-mol / L.
The patient died on 12Jul2021.
An autopsy was not performed.
Accountability score (s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures" Official Bulletin of the Minister in charge of Health n ° 84/50, 24 January 1985.
Published in Therapy 1985; 40: 111-8 No follow-up attempts are possible; information about lot/batch number cannot be obtained.
; Reported Cause(s) of Death: Multiple organ failure; massive hemoptysis; cardiogenic shock; vasoplegic shock; cardiac arrest