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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
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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