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Write-up: Case number PHHY2014PT165618 is an initial spontaneous report from a physician via health authority (HA reference number: PT-INFARMED-N201412-297) received on 17 Dec 2014 with a combined follow up information received physician and quality assurance department (QA reference number: 343913) on 19 Dec 2014 with a follow up report received from the physician on 23 Dec 2014 and a follow up information received from physician via health authority (HA reference number: PT-INFARMED-N201412-599) on 13 Feb 2015. This report refers to a 5 years old female patient. Her vaccination history included a dose of hepatitis A vaccine (manufacturer and batch number: not reported) one year before and first dose of BEXSERO (batch number: not reported) on 24 Aug 2014 and there was no adverse reactions after first dose. It was reported that the patient had no relevant clinical history until the date of the adverse event. She had no history of recent traveling. There was no history of other contacts infected with similar symptoms. In the postpartum, she had neonatal pathology thrombocytopenia following which she was admitted in oncology institute and was discharged with diagnosis of latent transient leukemia. The patient was followed for more than a year. Her current conditions included minor dysmorphia, deficiency in the fingers, facial asymmetry and retardation in development and speech and these were being investigated at genetic institute (no other information available). Her concomitant medications were not reported. Antecedents of adverse reactions to other medicines were unknown. She was vaccinated with second dose of BEXSERO (batch number: unknown) intramuscularly in 18 Nov 2014. On 26 Nov 2014, she had gastroenteritis of unknown etiology (diarrhea for duration of three days) characterized by blood and mucus and vomiting. She had a cerebral computed tomography (CT) scan done on 27 Nov 2014 which was normal. On 27 Nov 2014, she had fever with a body temperature greater than or equal to 38 degree C and strong headaches. She received a fluid therapy. On 30 Nov 2014, fever, bloody diarrhoea and headache stopped. The fever resolved when gastroenteritis was resolved. It was reported that she was very prostrate and sleepy. She was discharged since the symptoms improved. During the weekend, she experienced lack of strength, prostration and irritation and the events got worsened. She only wanted to sleep and there was a changed in level of conscience. This state worsened on 30 Nov 2014. On 02 Dec 2014, three weeks after second dose of vaccination; she went to the emergency department of the residential rea at 3 am in the morning with marked agitation and irritability. She was already apyretic and had gastrointestinal complaints. She had prostration, partial food refusal, paraesthesia and pain in the right lower limb with claudication. She was discharged after observation and analytical study performed referred her as normal. At home she was slightly better, but during the night appeared irritable and was shouting and crying. She had dystonic posture with cephalic deviation towards right, paresis of left upper limb and 4 episodes of vomiting. On 03 Dec 2014 morning, she was reactive slightly with conjugated deviation of the sight to the right and was greatly irritable while handling. She was transported to the hospital emergency room. On 03 Dec 2014, she was almost not able to respond. A CT scan performed showed changes suggestive of acute disseminated encephalomyelitis which was further described as new hypodense cortical-subcortical focus in the left internal (medial) parietal region, badly delimited with mass effect which could be of ischemic or infectious nature. On objective examination, she presented variations of the conscious state (agitation periods and irritability which were calmed down with mother''s contact) with conjugated deviation of the eyes to the right. Her pupils were isochoric and photoreactive. She had left upper limb paresis with pyramidal signal of the 4 members (left$gright), arterial hypertension and tachycardia. The physician reported that event was hyperacute. There was no fever. No nuchal rigidity was observed by the physician. She had depressed or altered level of consciousness, personality change, inconsistent or absent response to external stimuli, visual field defect, presence of primitive reflexes and motor weakness. She was greatly neurologically affected and whole body contracted. Her Glasgow coma scale was almost in score 8. During hospitalization, diagnostic tests were performed with samples of cerebrospinal fluid (CSF). Lumbar puncture was performed and cytochemical examination was without significant variations; bacteriology and virology examinations and search of oligoclonal bands were undergoing. The liquor was without suggestive changes of infection and the results were normal. No magnetic resonance imaging (MRI) was performed. She was detected with immunological complications. She had convulsive seizure which ceded with intravenous diazepam. Methylprednisolone was started intravenously at a dose of 30 mg/kg and she was transferred to the intensive care unit with the diagnosis of probable acute disseminated encephalomyelitis (ADEM). After this diagnosis, she was transferred to another hospital for neurological observation. She was then admitted in the intensive pediatric unit care during the night (on 04 Dec 2014 at 2:30 am). On admission, she presented the same neurological state (ECG 9) with arterial hypertension and tachycardia. The neurological state worsened and the outcome was not favorable. She was treated with benzodiazepines for the event. During the night, the events became worse and she required ventilation. She was intubated and measures of intracranial hypertension control were implemented without success. Repeated cranioencephalic CT showed worsening of initial lesions with diffuse cerebral edema on 05 Dec 2014 and signs of wedge. All sedoanalgesic medications introduced were suspended. Cerebral death was declared by the physician. The patient was only declared dead nearly 28 hours after, on 06 Dec 2014 at 11 am. After cerebral death, a CT scan was performed to confirm the patient''s status (cerebral death). The child was hospitalized during 4 days until being declared the brain death. The physician stated that blood tests were performed and the results of the blood tests were not reported and there might be stored specimens for additional testing. The physician did not have any additional information from genetic institute and no reports were available. According to the physician, stool tests were not performed and no information about gastroenteritis etiology was available. The final diagnosis was acute disseminated encephalomyelitis (ADEM). An autopsy was not performed as the parents refused it. The health authority assessed the event serious. The health authority reported the causality of the event as suspected to be related to the use of BEXSERO. The physician who analyzed the patient stated that vaccination or viral infection were two possible causes that led to the occurrence of the event. As per physician who evaluated the patient in the intensive pediatric care, she had a problematic immunity system and the cause of acute disseminated encephalomyelitis could be associated to gastroenteritis or vaccination as both conditions influence immunity system. The physician was not able to establish an association and had doubts about it. Based on the performed review on BEXSERO batches 131401A, 130301, 143301 and 144901, there was no evidence of any objections which occurred during the manufacturing process of finished product, including adjuvant and components used, that could compromise the quality of the product or that might be potentially related to the reported events. The quality assurance department confirmed that the involved batches were compliant with internal procedures and with current good manufacturing practices (cGMP) requirements. Combined follow up information received physician and quality assurance department (QA reference number: 343913) on 19 Dec 2014: Updated vaccination history, medical history, suspect vaccine date, events (encephalitis recoded as ADEM and added all other events) and physician comment and batch investigation summary updated. Follow up report was received from the physician on 23 Dec 2014: Updated lab investigations and reporter''s comments. Follow up information received from physician via health on 13 Feb 2015: Updated events (altered state of consciousness, cerebral oedema, convulsion, dystonia, eating disorder, hypertension, pain in extremity, pupillary light reflex tests abnormal, tachycardia, crying, paraesthesia, diarrhea, diarrhea hemorrhagic, pyramidal tract syndrome and hyporesponsive to stimuli), laboratory tests, procedure, clinical course of the event and treatment.
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