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Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # CH-1577272925-E2014-00151) on 08-JAN-2014. Case reported by a consumer to the Health Authorities on 08-Jan-2014 under the reference number 2013-06444. Case not medically confirmed. A female patient (weight and height not reported) had received a second dose of GARDASIL (batch number not reported) on 27-Jan-2009 via intramuscular route (site of administration not reported). The patient''s medical history included medication with contraceptives (several pills prescribed, registered trademarks unknown) since 2009. The patient had no other health disorder. The patient received a first dose of GARDASIL (batch number not reported) on 18-Nov-2008. The patient''s family medical history included a case of multiple sclerosis on one of the twin sons of the maternal great aunt of the patient. The patient''s mother reported that her daughter experienced burn-like pains and numbness in arms and legs since Feb-2009, some weeks after the second dose of GARDASIL administration, which occurred intermittently within the following months and which not responded well to anti-inflammatory medications. The mother make the link between vaccination and the daughter''s symptoms after seeing a TV show related to a complaint initiated by a patient diagnosed with multiple sclerosis and who experienced the first symptoms of the disease after a vaccination with GARDASIL. On 25 May 2009, the patient was hospitalised for a left optic neuritis. The first symptoms occurred on 22 May 2009 (progressive decrease of visual acuity, disturbed vision of colors). The visual acuity of the left eye was measured at 0.05/10. The rest of the neurologic status was without abnormality. Corticotherapy IV was administered to the patient, leading to an important improvement of visual acuity. Other exams performed (brain MRI and cerebrospinal fluid analysis) were compatible with an inflammatory condition, but nothing could be concluded. A control exam (MRI, in neurologic consultation) was scheduled at 3 months. The brain MRI performed on 01-Sep-2009 was compatible with a progression of inflammatory lesions of the white matter. Diagnostic criteria for a multiple sclerosis were present. The evolution was defined by remission and relapse of the disease. A second flare occurred on 07-Sep-2009: the patient experienced legs hypoesthesia with strength loss and walking disturbances, and diplopia on 17-Sep-2009. A third flare on Dec-2009 was characterized by a right very moderate papillitis. A fourth flare probably in Jun-2010 was characterized by sensory troubles. A fifth flare occurred in Aug 2010, with crural-brachial-facial dysesthesia and hypoesthesia, urinary symptoms and fatigue. No other flare was reported since then. The details concerning the motor, sensory and visual symptoms during these years were not provided but the neurologic status performed on May-2012, far away from the last flare, showed no real strength loss or sensory troubles. There were pains like sensations of burn and "needles in the back", at the level of the lower limbs and palmar sides of the hands. These pains were described at the time of the reporting as omnipresent, with strong exacerbations episodes, and were associated with spasms, occurring during the night in arms and legs. The ophthalmologic control performed on 12-May-2010, during optic neuritis and papillitis episodes, showed a visual function on the upper limit of the normal on both sides. The patient received the following therapies: IV corticotherapy during flares, (REBIF, 44 micrograms, via subcutaneous route, 3 times per week from 14-Oct-2009 to Mar-2013), which was replaced by TYSABRI (started on 30-Mar-2013), GILENYA (started since the mid of 2013). The treatment for the pain of intermittent symptoms included SAROTEN (since Dec-2009), and NEURONTIN (since Apr-2010, due to aggravation of paroxystic symptoms like left facial hemiparesia). The patient also received for sleep disturbances ZOLDORM. At the time of reporting, the patient had an autonomous life, though with daily pains. She had physical activity and followed a medical secretary online training course. At the time of reporting, multiple sclerosis and neuropathic pain were considered as not recovered. The patient recovered from optic neuritis on 12 May 2010. According to the Health Authority, the events were possibly related to the vaccination. The Health Authority considered the case as serious (disability).
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