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Write-up: Information has been received from SPMSD with MFR with E2014-00995, on 07-FEB-2014. Case received from the Health Authorities in a foreign country 04-Feb-2014 under the reference number LY20140105. A 12-year-old female patient had received first dose of GARDASIL (batch number J006656, expiry date: 31-OCT-2015) on 18-Sep-2013 and the second dose of GARDASIL (batch number J009200, expiry date: 31-OCT-2015) on 08-Nov-2013, both via intramuscular route. On 12-Nov-2013, Epstein-Barr virus serology was positive for IgG anti VCA, ant EBVNA and IgM antiVCA (not considered as a cause to the event). It was unknown why this serology was performed. A notion of excessive medication was reported. On 16-Nov-2013, the patient abruptly experienced right peripheral facial palsy. There was no notion of virosis in the previous days. On 20-Nov-2013, Epstein-Barr virus serology was positive again for IgG anti VCA, anti EBVNA and IgM antiVCA. Borrelia test was negative, C-reactive protein was at 0,2, White blood cell count at 4,48, Neutrophil count at 1,35. On 27-Nov-2013 ENT examination were performed, showing right isolated peripheral facial palsy of grade (House-Brackman). Parotidea area palpation was normal. Bilateral otoscopy was normal too. Tympanum were normal, and there was no anomaly on cranial nerves. According to the patient, the symptoms were regressing. On 04-Dec-2013, the patient underwent a further ENT examination, with the same facial palsy scoring. Speech therapy was initiated. On 27-Dec-2013, facial palsy scoring was still 4. An improvement in the lower area was observed. Palpebral occlusion was impossible. There was no hypoacousia and no dizziness. An audiogram was performed, which showed a very significant right perceptive deafness. The left side was unremarkable. Acoumetry showed left-lateralised Weber. On 02-Jan-2014, an MRI was performed. The results showed a normal pontocerebellar angle and no expansive process. At the time of reporting, the patient had not recovered. It is noteworthy that the patient had a medical history of recurring episodes malaises in 2012 with noneurological or heart etiology found after an exhaustive work-up. There was no recurrence since 2012. She had no medical history of allergy and there was no trip abroad. Vaccination schedule was up-to-date. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 I1) according to the Foreign method of assessment.
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