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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Information has been received from a specialist and from the health authority, concerning a 20 year old female with asthenia, anxiety/overwork syndrome and psychologic fragility since May 2008 and a history of cardiac murmur during childhood, who in OCT-2008 was vaccinated with the first dose of GARDASIL. The patient had no adverse effects after this dose. Concomitant therapy included BUSPAR, LEXOMIL, magnesium (unspecified) (+) pyridoxine hydrochloride and hormonal contraceptives (unspecified). On 27-DEC-2008 the patient was vaccinated with the second dose of GARDASIL, batch number not reported. It was reported that 3 days after the second dose of GARDASIL, i.e. in JAN-2009 the patient presented with hyperthermia at 38 C associated with breathlessness. After a malaise during shopping on 01-JAN-2009 the patient consulted her general practitioner; she had tremor and tachycardia. Blood analysis was performed on 03-JAN-2009 and revealed a slight hyperleukocytosis (12.4 103/mm3). By the evening on 03-JAN-2009 the patient presented with a malaise again but with no dyspnea and after taking BUSPAR. 2 hours later the intervention of EMUR (emergency medical mobile unit) could lead to recuperate a sinusal rhythm. Continuous arrhythmia with atrial fibrillation was diagnosed. The patient was transferred to medical intensive care service: she presented with bilateral mydriasis, hypothermia at 33.7 C, the result of measure of sugar in her blood was increased at 3.18 and she had cyanosis of face, ears, and extremities. Radiological examinations revealed a pneumopathy of the right middle pulmonary lobe and septal hypokinesia with paradoxical septal. There was no cocaine and no benzodiazepines. The patient presented with multiorgan failure under high dose of amines and then she dies in spite of the cardiopulmonary by-pass and extra corporeal oxygenation assistance. An autopsy was performed (unspecified date) and found no cause of death, also reported as information on autopsy was still awaited. Other business partner numbers include: E2009-00502. Additional information has been requested.
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