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Write-up: Information was received from sanofi pasteur with manufacturer number of E2013-10994 on 19-Dec-2013. Case was received from the Health Authorities on 19-Dec-2013 (reference no. PEI2013077167). Case is medically confirmed. A 15-year-old female patient received the first dose of GARDASIL (lot-no. NP14780, expiry date Mar-2012) IM into the left upper arm on 03-Nov-2011. On 04-Nov-2011, the patient developed dizziness attacks and tiredness and felt unwell. Patient''s medical history included EBV-infection, gastroenteritis (exact onset not reported) and chronic gastritis and since Oct-2011 intermittent dizziness. U1 (first examination of newborn program) on 19-Aug-1996 showed that the patient was born by Caesarean section because of existing disproportion. U4 on 10-Dec-1996 showed dysplasia of both hips requiring abduction diapers. Family anamnesis included rheumatoid arthritis. Lab data of 09-12-2011 was normal. Serology tests on 09-Dec-2011 revealed EBV-VCA IgM 55.8 U/l, EBV-VCA IgG 113.0 U/ml, EBV-EBNA IgG $g600 U/ml and EBV-IgG Immuno blot was positive. Based on these findings a reactivated acute infection was assumed. The patient was hospitalized from 07-Feb-2012 to 16-Feb-2012 due to persisting nausea, dizziness attacks (occurring once or twice per months, then about 3 times per day) and one time syncope. Diagnosis was "suspicion of postinfectious changes in cranial MRI". On admission, physical examination, lab tests, beta-HCG in urine, and urine analysis were normal. Stool was negative for worm eggs. Serology was negative for Borrelia, Lues and Toxoplasmosis antibodies. Furthermore, serology was positive for suspicion of recent EBV infection, past measles, mumps and rubella infection or vaccination, past varicella infection and mycoplasma infection. Cerebral fluid showed an increased HSV and VZV antibody index of 1.7 and 1.5, respectively. ENA was negative, ANA increased at 1:80, ANCA serology and double-stranded DNA antibodies were normal. Stool culture revealed enteropathogenic E. coli (EPEC). Ultrasound of abdomen on 07-Feb-2012 was normal as well as EEG, ECG and eye examination on 09-Feb-2012. Neurological examination showed normal visual evoked potentials. MRI of brain on 08-Feb-2012 showed periventricular signal intense areas. 3 out of 4 Barkhof criteria for diagnosis of disseminated encephalomyelitis were met, differential diagnosis was ADEM. Cerebral microangiopathies could not be excluded but were assumed as unlikely due to patient''s age. Secondary MRI finding included sinusitis. Gastroscopy on 09-Feb-2012 revealed fundus cascade, otherwise was normal. Helicobacter test was negative. Histology showed chronic gastritis. MRI of spine on 13-Feb-2012 was normal as well as ear, nose and throat examination. Based on these findings a postinfectious event was considered as the most probable cause. The patient was discharged in good general condition. On 27-Mar-2012 the patient presented to the neuropediatric ward for check-up of the postinfectious changes seen in the brain MRI on 08-Feb-2012. The patient reported no more dizziness attacks and only mild ongoing nausea. Neurological examination and EEG were normal. On 16-Apr-2012 the patient presented to the doctor and reported that since Feb-2012 she had had symptom free days alternating with days of mild headache, nausea and tiredness. Physical examination was normal. MRI of brain revealed new small foci in the anterior horn compared to the previous MRI. After IV gadolinium administration, no signs of enhancements were seen. ADEM, multiple sclerosis or other demyelinating disease was suspected. The patient was hospitalized from 26-Apr-2012 to 07-May-2012. Physical examination was normal. CSF test on 30-Apr-2012 was normal. CSF serology on 30-Apr-2012 showed HSV IgG titre of 252. Serum serology on 30-Apr-2012 showed HSV IgG antibodies 1:28000 and positive HSV-1 IgG antibodies (ELISA). Laboratory test on 02-May-2012 showed normal thyroid function. MRI of brain on 04-May-2012 was unchanged. TOF-angiography was normal. Eye examination on 07-May-2012 was normal. Therapy included ANTRA for gastritis. During hospitalization, the patient hardly had nausea and only mild dizziness. On 21-Jun-2012 the patient presented to the neuropediatrician. Patient''s development anamnesis was without pathological findings. At that time, onset of dizziness was reported as "October 2011" (before vaccination). An EBV-associated ADEM was assumed but could not be proven by CSF tests because of no EBV-DNA had been detected. Since discharge from hospital the patient had not experienced dizziness. However, the patient had no physical or other stress, had been sleeping a lot, and after getting up in the early afternoon, she had been sitting or lying most of the time. Nausea was still persisting. However, the symptoms of nausea had changed in terms of stomach pain or rather feeling of pressure in the abdomen which lasted for about 1 hour and spontaneously regressed. The patient herself discontinued omeprazole therapy. Since 29-Jun-2012 the patient received physiotherapy focused on children''s central nervous system. On 25-Oct-2012 the patient was presented to a consulting neurologist. Suspicion of "chronic inflammatory CNS disease with known fatigue symptoms" was stated. Laboratory values of the same day were normal. The patient was again hospitalized from 05-Nov-2012 to 09-Nov-2012. At that time, "ADEM post vaccination" was mentioned the first time. It was reported that "following HPV vaccination in November 2011, the girl developed persistent daytime tiredness". Physical and neurological examinations were normal as well as laboratory values of 05-Nov-2012. It was reported that "previous lumbar punctures showed no oligoclonal bands but existing barrier disturbance and increased CSF proteins" (no date was reported, this is in discrepancy with previous CSF findings). Vasculitis screening was normal. McDonald criteria for multiple sclerosis were not met. Medication included metoclopramide (MCP) drops and VOMEX. MRI of cervical spine and head on 15-Nov-2012 revealed no new findings. Even though T1 hypointensities were regressing, ADEM was suspected. On 10-Jan-2013 an unspecified "psychological disorder" was suspected. On 03-May-2013, the patient presented for emergency to the outpatient unit. Since Jan-2013 she had been feeling well, however on 29-Apr-2013 dizziness and nausea reoccurred, and she felt unwell. Rehabilitation in 2012 had not been successful because of bad experiences in the psychosomatic clinic with addicted patients. Therefore rehabilitation had been stopped after few days. MRI of head on 03-May-2013 showed unchanged lesions of white matter, no new lesions and no barrier disturbance were detected. Based on all findings, the current symptoms were suspected to be a psychosomatic origin (several hospitalizations in the past months, a lot of stress, abnormal eating behavior including weight loss, tragic family fate). Final diagnosis was "suspicion of EBV-associated ADEM". At the time of reporting, the patient had not recovered. Upon internal medical review the company added the following AEs which were mentioned in the source documents but not coded by HA: reactivation of EBV infection, chronic inflammatory CNS disease, syncope, psychosomatic disease.
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