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Write-up: Case received from a healthcare professional, a physician who is a member of the Advisory Board of Vaccination on 10-SEP-2012. A 13 year-old female patient, with a medical history of poorly controlled asthma, had received the second dose of a GARDASIL, batch number not reported, route and site not reported) date not reported. The patient was vaccinated according to the healthcare centre vaccination schedule. It was reported that 12 hours after vaccine administration (exact date not reported), the patient presented with severe asthma. The patient was taken to the hospital where she presented cardio-pulmonary arrest, the patient was transferred to the paediatrician ICU ward of another hospital, where she died. It was reported that the patient had received the first dose of GARDASIL (date of administration not reported), after vaccination the patient''s asthma aggravated. According to the reporter (he was not the physician who treated the patient directly) this case of death was not related to vaccine administration. No further information was reported. Additional information received on 11-SEP-2012, from a healthcare professional, an ICU ward physician who treated the patient: A 13-year-old female patient, born 03-JUL-1999, with a medical history of poorly controlled asthma and allergy to pollen, had received the second dose of GARDASIL, batch number not reported, route and site not reported) on 23-AUG-2012. Previous to vaccine administration and according to the family, the patient presented a mild dyspnea, which she frequently had. According to the reporter, 12 hours after vaccine administration, on 23-AUG-2012, the patient presented with a severe difficulty in breathing and headache. On 23-AUG-2012 at 20:20 hrs, the patient arrived at the healthcare center. The patient was unable to breathe, she vomited once (cessation date 23-AUG-2012) and then she lost consciousness. The patient was transferred to the hospital. She arrived 23 minutes later with asystolia. Cardiac arrest. Cardiopulmonary resuscitation was performed during 12 minutes. The patient was intubated, 3 doses of adrenaline were administered. 17 minutes after they were able to reanimate her. Bronchodilators, Ketamine and Bicarbonate were administered. The patient was transferred in a mobile paediatric intensive care unit to the hospital''s paediatric criteria care unit. MRI and scanners were performed. Neurological lesions were detected. The patient was diagnosed with severe neurological status deterioration and an almost flat encephalogram. On 08-SEP-2012 the patient died. Cause of death was ischemic encephalopathy. The family referred that after the patient had received the first dose of GARDASIL the patient had a mild-moderate asthmatic crisis. According to the reporter, who contacted the patient''s paediatrician, the patient received the first dose of GARDASIL on 27-JUL-2012, route and site not reported, batch number not reported. On 31-JUL-2012 the patient went to the healthcare center to report to her paediatrician that she had presented an asthmatic crisis (date not reported) after vaccination and she had been treated in the hospital. According to the physician who treated the patient in the ICU there is possible relationship between events and vaccination. Further information is expected. Additional information received on 12-SEP-2012, from the physician''s pediatrician: The patient received the first dose of GARDASIL (batch number G007396, route and site not reported) on 23-JUL-2012 (this date is different to the one reported by the ICU pediatrician but it is the one included in the clinical record of the patient at her healthcare centre). According to the pediatrician the patient went to the hospital on the 29-JUL-2012 due to a severe asthmatic crisis where she was treated and controlled. The reporter don''t know if the patient was admitted to hospital or treated at the emergency room. No further information on this episode was reported. On 31-JUL-2012 the patient attended his office to report the episode. At that time the patient was well. On 23-AUG-2012 the patient was administered the second dose of GARDASIL (batch number G007396, route and site not reported). According to the clinical record of the patient she had history of allergic asthma, not controlled because she did not follow the recommended treatment (prophylaxis with SYMBICORT), allergy to acaridae. The patient had frequent moderate exacerbations and previous episodes of bronchitis since year 2010, which is the date since the pediatrician had patient history. The patient had history of intrauterine growth retardation and short stature. According to the pediatrician opinion relationship of adverse events and vaccination is unknown. No further information is reported.
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