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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||- / 1||- / OT|
Administered by: Other Purchased by: ??
Symptoms: Acute respiratory distress syndrome, Apnoea, Arrhythmia, Atrial fibrillation, Blood potassium, Blood sodium, Body temperature, C-reactive protein, Cardio-respiratory arrest, Computerised tomogram, Depressed level of consciousness, Hypernatraemia, Hypoxia, Infection, Oxygen saturation, Oxygen saturation decreased, Pyelonephritis acute, Pyrexia, Ultrasound Doppler, Ultrasound scan, Computerised tomogram head, Ischaemic stroke, Lower respiratory tract congestion, SARS-CoV-2 test, Magnetic resonance imaging head
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:
Write-up: Cardio-respiratory arrest; Ischemic stroke; ARDS; Obnubilation/clouding of consciousness; Hypoxaemia; AFib; febrile; arrhythmia; infectious syndrome; desaturation; bronchial congestion; respiratory pauses; Hypernatraemia at 151 mmol/L; suspected acute pyelonephritis; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-NY20210892. Safety report unique identifier FR-AFSSAPS-2021047876. A 75-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 03Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. Medical history included ongoing knee prosthesis insertion, hypertension arterial, hip prosthesis insertion, shoulder tendinitis, depression. Concomitant medications included candesartan cilexetil taken for hypertension, start and stop date were not reported; mirtazapine (NORSET) taken for depression, start and stop date were not reported; rilmenidine taken for hypertension, start and stop date were not reported; escitalopram taken for depression, start and stop date were not reported. On 27Mar2021, the patient was hospitalised for ischemic stroke. On admission, atrial fibrillation, febrile, COVID-19 polymerase chain reaction negative. Patient also experienced complete arrhythmia by atrial fibrillation, respiratory distress syndrome, hypoxemia, clouding, acute pyelonephritis and died from cardiorespiratory arrest on 04Apr2021. On 27Mar2021, brain magnetic resonance imaging showed somewhat recent ischemic stroke. Doppler ultrasound showed multiple intracranial stenosis. Echography showed left ventricular ejection fraction 65%, hypertrophic cardiomyopathy homogenous potassium was 3.2 mmol/L, C-reactive protein was 17 mg/L and Covid-19 polymerase chain reaction test was negative. During hospital stay, brain scan did not evidence hemorrahgic transformation of stroke and chest scanner did not evidence pneumopathy. Acute pyelonephritis was suspected. The patient was intubated and ventilated. The patient died from cardiorespiratory arrest on 04Apr2021. Cerebral magnetic resonance imaging: Somewhat recent ischemic stroke of the right anterior cerebral region with a long-standing ischemic history of the right posterior cerebral region, multiple intracranial stenoses. Ultrasound of the neck vessels: bilateral multiple intracranial stenosis predominantly on the right middle cerebral artery, basilar trunk not recorded. Transthoracic ultrasound: left ventricle not dilated, left ventricular ejection fraction 65%, homogeneous hypertrophic cardiomyopathy, left atrium moderately dilated. Hypokalaemia at 3.2 mmol/L. C-reactive protein 17 mg/L. Due to complete arrhythmia by atrial fibrillation, implementation of ELIQUIS, but replaced immediately by curative CALCIPARINE 12,500 IU 3/day in view of the impossibility of taking medication orally. Evolution marked by the onset of an infectious syndrome with respiratory distress, desaturation and clouding of consciousness. Hypernatraemia at 151 mmol/L. The computerised tomography brain scan ruled out a haemorrhagic transformation. A computerised tomography chest scan did not reveal pneumonia. Unfavourable evolution with sudden degradation, bronchial congestion, respiratory pauses. Initiation of a double antibiotic therapy (ceftriaxone aminoglycoside) in view of the suspicion of severe pyelonephritis. Orotracheal intubation and ventilation implemented. Cardiorespiratory arrest and death on 04Apr2021. The serious criteria of events Cardio-respiratory arrest, Ischemic stroke, ARDS, Obnubilation/clouding of consciousness, Hypoxaemia was reported as Death and Hoapitalization, event suspected acute pyelonephritis was death, event AFib was Hoapitalization. The outcome of event AFib was not recovered, events Cardio-respiratory arrest, Ischemic stroke, ARDS, Obnubilation/clouding of consciousness, Hypoxaemia was fatal, other events was unknown. The patient died on 04Apr2021. It was not reported if an autopsy was performed. Conclusion: 75-year-old woman, treated for high blood pressure and depression, vaccinated with a first dose of COMIRNATY (batch not specified), who 25 days later was hospitalised for a somewhat recent ischemic stroke with multiple (prior) intracranial stenosis. Context of complete arrhythmia by atrial fibrillation unknown previously. Unfavourable evolution with onset of an infectious syndrome, respiratory distress, desaturation and clouding. Suspicion of acute pyelonephritis. Death 8 days after admission to hospital due to cardiorespiratory arrest. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: cardiorespiratory arrest; Ischemic stroke; ARDS; Obnubilation/clouding of consciousness; Hypoxaemia; suspected acute pyelonephritis
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