VAERS ID: 1592684

Description

This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [FR-AFSSAPS-MP20215396]. A 15-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 11Jul2021 07:30 (Lot Number: Unknown) (at the age of 15-year-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing asthma, ongoing Barlow's syndrome, ongoing Marfan's syndrome. The patient's concomitant medications were not reported. In good health overall, apart from a loss of 10kg over one year (since entering high school). During the day (11Jul2021), asthenia and isolated arm pain. The next day (12Jul2021), headaches yielding under Doliprane. On 13Jul2021, around 16:30 (last moment conscious view), her mother drops her off to her father. Father watered the garden and she cleaned the garage to prepare for her birthday party. On 13Jul2021 17:20, her father found her in cardio respiratory arrest, back to the ground, next to a ladder. No flow was unknown. At 17:30 arrival of firefighters: 2 external electric shocks were given and 1 mg of adrenaline injected. Moderately reactive pupils. At 17:50 arrival of Specialist mobile emergency unit: asystole (Life-threatening). Two injections of 1 mg of adrenaline, transition to ventricular fibrillation. 2 external electric shock, 2 ampule of Cordarone and one ampule of Calcium Gluconate. Return to regular sinus rythme without disturbance of repolarization and resumption of a pulse. Orotracheal intubation (probe no 6). New: 1 external electric shock, one ampule of Cordarone and 1 mg of adrenaline. Return of a sinus rhythm but presence of a sub ST in infero lateral. 90/60 mmHg arterial pressure excluding sedation. Tight areactive bilateral miosis pupils. Ventilated in Ventilator-Associated Conditions but presence of spontaneous ventilation requiring sedation by Hypnovel and Sufentanyl and 10 mg of Nimbex. Parallel introduction of Noradrenaline 0.8 mg/h. No filling. In total: low flow of 30 minutes. Recovered and transfer to intensive care. Examinations: biology: complete blood count normal, C-reactive protein 1.4. Coroner considered as normal no coronary dissection. Computed tomography scan Computed tomography arterial portography: No aortic dissection or large vsx, no intracranial bleeding, the super sigmoid aortography does not show any aortic insufficiency. The ascending aorta is moderately dilated. Computerised tomogram head: no bleeding, no traumatic injury. Electrocardiogram: Not very evocative. Respiratory rate. Maintenance of sedation, temperature control at 36 degrees. Complicated cardiac arrest of a Takotsubo. Trans-thoracic echocardiography finding a 30% altered left ventricular ejection fraction with kinetic disorders suggestive of Takotsubo (post stress?). More doubt about intra-left ventricular thrombus. Low left ventricular filling pressures. Integral time speed= 8. Inferior vena cava= 15. 15Jul2021 Appearance in the morning of continual clonies of the multiple sulfatase deficiency, put under Keppra increased to 750x2. Electroencephalography results pending + Left transcranial doppler more disturbed than the right (Vdiastolic 20 vs 40 on the right), Control contrast enhanced computed tomography scan superimposable at the level of large vsx, but appearance of parenchymal parenchymal hemispherical hemispherical right upper cerebellar areas of ischemic appearance. 20Jul2021 pathological awakening, inhalation lung disease, myocarditis assessment in progress (negative). 23Jul2021 no sign of wakign up flat electroencephalogram alternating with a few waves of intermittent activity. Computered tomography scan stability of ischemic lesions appearance of cerebral edema compatible with anoxo-ischemic lesions, put under Mannitol. Cardio: cardiac magnetic resonance imaging in favor of a takotsubo, myocarditis unlikely, infective and immunological workup negative. 27Jul2021 Pathological electroencephalogram, Keppra introduction. Computered tomography scan increase in cerebral edema reaching almost the entire sustentorial stage, sudden episodes of desaturation. The COVID serology returns positive (Ig G antiS and antiN and IgM), re-reading of the entry serology concluded with a Covid infection starting at the same time as the anti-covid vaccination. 30Jul2021 retro-rolandic aspect of brain death, vegetative coma. Decision to limit therapy. Complete file no further information. The patient died on 07Aug2021. An autopsy was not performed. Cause of Death: Anoxia cerebral and Cardiac arrest while outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest; Anoxia cerebral