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This is VAERS ID 416008

Case Details

VAERS ID: 416008 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
   Days after vaccination:252
Submitted: 2011-01-31
   Days after onset:357
Entered: 2011-02-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antibody test negative, Antinuclear antibody negative, Basophil percentage decreased, Blood creatine phosphokinase increased, Blood glucose normal, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M decreased, Blood lactate dehydrogenase increased, C-reactive protein normal, Complement factor C3, Complement factor C4 decreased, Complement factor normal, Cytomegalovirus test negative, DNA antibody negative, Diplopia, Electromyogram normal, Eosinophil percentage decreased, Epstein-Barr virus antibody positive, Eyelid ptosis, Haematocrit normal, Haemoglobin normal, Lymphocyte percentage, Mean cell volume normal, Monocyte percentage, Neurological examination abnormal, Neutrophil percentage, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Ocular myasthenia, Platelet count normal, Protein total normal, Red blood cell count normal, Red blood cell sedimentation rate normal, Scan with contrast normal, Ultrasound scan normal, White blood cell count normal, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Viral infection; Purpuric rash
Diagnostic Lab Data: Magnetic resonance imaging, 01?Feb10, with contrast: negative. Diagnostic laboratory test, ??Feb10, Anti-tireoglobulin antibodies: negative; Diagnostic laboratory test, ??Feb10, Anti-peroxidase antibodies: negative; Diagnostic laboratory test, ??Feb10, anti RAB antibodies: negative; Diagnostic laboratory test, ??Feb10, Anti-MUSK antibodies: negative; Diagnostic laboratory test, ??Feb10, Anti-TSA receptor antibodies: negative; X-ray, 08Feb10, within normal limits; Electromyography, 18Feb10, motor conduction of the facial and right ulnar nerves within normal limits; Ultrasound, 18Feb10, mediastinic sonogram: excluded the presence of timoma, normal mediastinum; Magnetic resonance imaging, 18Feb10, venous, of the right intracranial district: did not show any aneurism; Epstein-Barr virus antibodies, ??Feb10, Ab VCA IgG and EBNA IgG present (past infection); Serum ANA, ??Feb10, absent; Cytomegalovirus antibody screen, ??Feb10, absent; Component C3 test, ??Feb10, 99 mg/dl; Component C4 test, ??Feb10, 9 mg/dl; Deoxyribonucleic acid antibodies test, ??Feb10, absent; Serum immunoglobulin G test, ??Feb10, 1259 mg/dl; Serum immunoglobulin M test, ??Feb10, 211 mg/dl; Serum immunoglobulin A test, ??Feb10, 227 mg/dl; WBC count, 08Feb10, 6150 /mm^3; Basophil count, 08Feb10, 0.3%; Eosinophil count, 08Feb10, 0.7%; hematocrit, 08Feb10, 38.0%; Lymphocyte count, 08Feb10, 36.6%; Monocyte count, 08Feb10, 5.5%; Neutrophil count, 08Feb10, 56.9%; Platelet count, 08Feb10, 326.000 /mm^3; Serum C-reactive protein, 08Feb10, 0.2 mg/dL; Serum LDH, 08Feb10, 179 mU/ml; Serum creatine kinase, 08Feb10, 143 mU/ml; Serum glucose, 08Feb10, 90 mg/dl; Total serum protein, 08Feb10, 7.5 gr/dl; Red blood cell count, 08Feb10, 4,370.000 /mm^3; Serum hemoglobin test, 08Feb10, 12.7 g/dL; Erythrocyte sedimentation rate, 08Feb10, 2; Mean corpuscular volume, 08Feb10, 87.0 fl
CDC Split Type: WAES1101USA03099

Write-up: Information has been received from a Health Authority (case n. 132695). The case was medically confirmed. A 12 year old female patient was vaccinated IM on 01-JUN-2009 with the third dose of GARDASIL (Lot # 0772x, batch # NK15900). On 08-FEB-2010, she presented with sudden right eyelid ptosis associated with diplopia. These symptoms occurred inconsistently during the day, worsening in the evening. She was admitted to the hospital. A brain MRI with contrast had been taken 1 week before and was negative. Lab work performed included: WBC 6150; N: 56.9; L: 36.6; M: 5.5; E: 0.7; B:0.3; RBC: 4.370.000; Hb: 12.7; Htc: 38.0; MCV:97.0; Plt: 326.000; C-reactive protein: 0.2; sedimentation rate: 2; glycemia: 90: LDH: 179: CK: 143. Chest X-ray was within normal limits; Anti-EBV antibodies: Ab VCA IgA and EBNA IgG present (past infection); Anti CMV antibodies: absent; Antibodies anti-DNA, ANA: absent; Anti-reoglobulin antibodies: negative; Anti-peroxidase antibodies: negative; C3: 99; C4: 9; Anti-TSA receptor antibodies: negative; Total protein: 7.5; IgG: 1259; IgA: 227; IgM: 211; Anti-MUSK antibodies: negative and Anti-RAB antibodies: negative. A neurological consultation performed on 18-FEB-2010, noted moderate eyelid ptosis in the right eye with slight elevation deficit and upward diplopia. An Electranyography showed motor conduction of the facial and right ulnar nerves within normal limits. Mediastinic sonogram: excluded the presence of timoma, normal mediastinum. Venous-MRI of the right intracranial district did not show any aneurisms. The patient was treated with MESTINON. During admission the eyelid ptosis improved in the morning hours to progressively worsen during the day and in the evening. The final diagnosis: possible myasthenia. The patient was referred to a Neurological Institute. The patient was re-evaluated on 25-FEB-2010, she appeared to be responding to the therapy with MESTINON. Ptosis was noted also in the left eye, she complained diplopia in all directions except downwards. Possible ocular myasthenia was confirmed, to be re-evaluated when antibodies results for MUSK, ENA and ANCA were available. Neurological evaluation on June 2010: ptosis of the right eye still present with mild ptosis of the left eye as well. Diplopia still present. The diagnosis of ocular myasthenia with negative anti-AAB and anti-MJSK antibodies was confirmed. The patient was initiated on steroid therapy with DELTACORTENE. At the tine of reporting the patient had not yet recovered. HA coded diplopia, ptosis and ocular myasthenia. The events of diplopia, ptosis and ocular myasthenia were considered to be disabling events. The case was closed. Other business partner numbers include: E2011-00405. No further information is available.

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