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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Information has been received from a consumer on 10-MAY-2011 and not medically confirmed. A Female patient (age unknown) had received the second dose of GARDASIL (lot and batch number not reported) on unspecified date. On an unspecified onset of time she experienced significant joints pain. At the time of reporting the patient had still not recovered. Additional information received from a pediatrician on 28-MAY-2011. Case medically confirmed. The patient was 15 year old and had no relevant medical history. She had received the first dose of GARDASIL (lot and batch number not reported) on 22-DEC-2010 together with a dose of MENINGITEC (other manufacturer), and the second dose of GARDASIL (lot and batch number not reported) on 23-FEB-2011. Eight days after the second dose, she complained from violent pain in hands and feet, which awoke her in the morning and disturbed her in her daily activities and went increasing during the weeks. She was seen by the reporter on 26-MAR-2011 for arthralgia, sensation of ankylosis, but without morning stiffness. The examination showed joints which were not edematous, nor swollen but it showed a deformation of fingers in lateral valgue. Those pain spread to the wrists. There was no fever. A work-up was performed and was normal: Blood count and differential white count, sedimentation rate: 5/17, C-reactive protein (CRP): 2. Latex, Waler Rose, anti-DNA antibodies were negative; Immunoglobulins G, A, M were normal, C3 and C4 normal. As those pain persisted, spread to toes and were invalidating regards to school, the patient went to see a rheumatologist, who confirmed the absence of systemic disease or rheumatological disease. Viral serologies were negative. At the time of reporting, the pains had been persisting for two months and were not decreasing. The patient needed APRANAX 2 to 3 times a day. Follow up received on 26-OCT-2011. Fifteen days after the second dose (and not 8 as previously reported), the patient experienced migratory arthralgia from fingers to wrists and to ankles. She had morning stiffness. The pain was increased on efforts. She also complained from lumbar pain. The inflammatory work-up was normal. She was seen by a rheumatologist. The physical examination was normal. An appointment with an internal medicine physician was scheduled. The patient was seen for her lumbar pain. The physical examination showed sensitivity on 3 vertebras. The patient was due to be seen again. At the time of reporting, the patient had not recovered. Follow-up information received on 28-MAR-2012: case upgraded to serious upon the basis on the following information: The patient had no swelling, no redness and no inflammation. She observed having fingers deformity. She had difficulties writing in her daily life and need school assistance. Furthermore, she could not longer practice sport. An individual plan had been put into place at school. The patient was suffering since several months and experienced pain in whole body of myalgia type. No diagnosis had been made. The physician agreed to consider this case as serious due to the patient''s daily life difficulties leading to disability. Other business partner numbers include E2011-02891. No further information is available.
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