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Life Threatening? No
Write-up: This spontaneous report as received from a physician refers to a 11 year old female patient. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL dose 1, 0.5 ml dose (lot, and route not reported), but she did not receive the complete vaccination schedule. So, 11 months later of receiving the first GARDASIL dose the patient''s treating physcian prescribed her to re-start a new vaccination schedule. On an unknown date, after receiving the second dose of the new schedule of GARDASIL 0.5 ml (lot and route not reported), the patient experienced intense arm pain where was administered which lasted a week. On an unknown date, after receiving the third dose of GARDASIL 0.5 ml dose (lot and route not reported), the patient experienced intense arm pain again where the vaccine was administered accompanied by swollen, redness and hot hand. Two weeks later this symptoms were extended to another arm and finally to the whole body. The pain was accompanied by severe Paresthesia. So, the patient was disabled because of her symptoms, so she stopped going to school. In addition the patient developed insomnia and deep fatigue. The reporter denied any trauma history, neither personal nor familiar psychiatric problem in the patient. On an unknown date, the patient underwent to several diagnostic tests including: Unspecified blood tests that were negative for infection, inflammation and autoimmune diseases, cerebrospinal fluid test which showed normal result, head and neck magnetic resonance imaging and electromyography revealed normal results. Seven months later of the beginning of the patient symptoms she continues experiencing generalised pain, paresthesia, insomnia and fatigue. The patient received therapy with unspecified analgesic, anti-inflammatories and anti-neuropathies but they were ineffective. On an unknown date, seven months later of the beginning of the symptoms, a physical evaluation was performed and showed a girl with obvious data of suffering caused by her pain and paresthesia. In addition a neurological test was performed that showed generalised allodynia. The 18 tender points were positive for fibromyalgia; there are not any data of articular phlogosis. According to the reporter the probable diagnostic is complex regional pain syndrome (reflex sympathetic dystrophy) that evolved to fibromyalgia after the vaccination with GARDASIL. The outcome of severe paresthesia, deep fatigue, insomnia, fibromyalgia, generalized allodynia and generalized pain was reported as not recovered. The outcome of swollen, redness and hot hard, did not received the complete vaccination schedule and swollen/hot extended to the whole body was unknown. The events of paresthesia and generalized pain were considered serious due to disability by the reporter. This is one of two reports from the same source (2014PVMX0122). Additional information has been requested.
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