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This is VAERS ID 517751

Case Details

VAERS ID: 517751 (history)  
Age: 15.0  
Gender: Female  
Location: Foreign  
   Days after vaccination:1
Submitted: 2013-12-27
   Days after onset:784
Entered: 2013-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Angiogram normal, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody increased, CSF oligoclonal band absent, CSF protein increased, CSF test normal, Central nervous system inflammation, Dizziness, Double stranded DNA antibody, Ear, nose and throat examination normal, Eating disorder, Electroencephalogram normal, Endoscopy upper gastrointestinal tract, Epstein-Barr virus antibody positive, Epstein-Barr virus infection, Escherichia test positive, Fatigue, Helicobacter test negative, Histology abnormal, Human chorionic gonadotropin normal, Malaise, Morbillivirus test positive, Mycoplasma test positive, Nausea, Neurological examination normal, Nuclear magnetic resonance imaging brain abnormal, Ophthalmological examination normal, Rubivirus test positive, Rubulavirus test positive, Simplex virus test positive, Sinusitis, Syncope, Thyroid function test normal, Ultrasound abdomen normal, Urine analysis normal, Varicella virus test positive, Visual evoked potentials normal, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Demyelination (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: 10/2011, Dizziness; Gastritis; Immunisation
Preexisting Conditions: Gastroenteritis; Epstein-Barr virus infection; 12/10/1996, Developmental hip dysplasia; 08/09/1996, Caesarean section
Diagnostic Lab Data: Angiogram, Normal; Antineutrophil cytoplasmic antibody, normal; Antinuclear antibody, increased at 1:80; Antinuclear antibody, Negative; 02/07/2012, CSF test, HSV antibody index 1.7, VZV antibody index 1.5; 04/30/2012, CSF test, Normal; 04/30/2012, CSF test, serology: HSV IgG titre 252; Culture stool, positive for EPEC; 02/07/2012, Culture stool, Negative for worm test; Double stranded DNA antibody, Normal; 02/13/2012, Ear, nose and throat examination, Normal; 02/09/2012, Electrocardiogram, normal; 02/09/2012, Electroencephalogram, normal; 03/27/2012, Electroencephalogram, Normal; 02/09/2012, Endoscopy upper gastrointestinal tract, fundus cascade; 02/07/2012, Epstein-Barr virus antibody, positive; Helicobacter test, Negative; Histology, sho
CDC Split Type: WAES1312DEU011435

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 wa

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