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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (DK-1577272925-E2013-10614) on 10-DEC-2013. Case of adverse event received from non-health care professional via Health Authorities on 10-Dec-2013 under the reference number DK-DKMA-ADR 22333686 and EFO7608. The primary reporter was the mother to the patient. A 15 year old female patient (weight: 62 kg; height: 170 cm) with no other health problems in general, had received the first dose of GARDASIL (batch number not reported) via not reported route of administration in not reported site of administration on 11-Feb-2009 and thereafter, the same day (11-Feb-2009), all the adverse events began. She developed: never completely rested, difficulty sleeping or sleeping constantly, memory impaired (can read a page in a book and no recall), fever with unknown cause, confused (become easily confused and find it difficult to follow a conversation) feel general malaise (sick), headache (severe headache daily), swollen lymph glands (many swollen lymph nodes in the neck and groin) and she has been hospitalized and had taken a biopsy of the lymph glands (without any conclusion). Often influenza symptoms, stabbing tingling pain in muscles without cause, heavy menstrual bleeding, chills (time and again). Having a hard time keeping warm, lactose intolerant (have suddenly become lactose intolerant), joint pain (constant pain in the joints), lack of coordination (it is hard to concentrate on anything in longer period of time (few minutes)), severe abdominal pain (the patient has been hospitalized several times with suspected appendicitis), often elevated CRP, infection in the body but no cause can be found, pain behind the eyes, throat pain, wheezing (when she lies down, her breathing wheeze (conclusion = asthma (no further information provided)), leg pain, back pain, sleep 18-20 hours a day, shortness of breath (quickly out of breath and feel no air comes into the lungs), strong sound sensitivity, strong sensitivity to light, dizziness (cannot stand for long periods without being dizzy, darken before the eyes (the HA coded LLT near fainting), muscular weakness (according to the mother, the doctor says that she has lost muscle mass), toothache, chest tightness (worst when she is lying down), foggy hearing/brain (can hear what people say, but do not understand what they say, the HA coded LLT foggy feeling in head), unexplained bruising (often unexplained bruising on the legs), unusual tiredness and weakness that does not improve even after sleeping long hours, breathing problems (she has been hospitalized several times (dates not reported) with trouble breathing). Diffuse pain in the legs, arms, neck or whole body. It can be stabbing pain, tingling pain, and they can wander around. Palpitations, chest tightness, chronic vitamin D deficiency, frequent urination. Stomach problems with either constipation or diarrhea, nausea, bloating. Sweat attack, running nose, balance problems and clumsiness (drop things and go into chairs and door frames). Patient''s mother says that her daughter in 2010 was diagnosed with ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) of hospital, but many doctors believe differently. And that a doctor at Infectious Diseases clinic, felt that her mind might play her tricks to believe that she is sick. Note: she has been a perfectly normal healthy and active girl. She was active in school, loved to ride and was at the riding school several times a week and also she played soccer as often as she can. She has since she was 13 years been working in several places after school. She was a diligent and hard-working girl who put great pride in getting things done. She was very well-liked at school and at work. Unfortunately changed everything for her. She struggled in vain to keep up at school. Fought to pass the 9th and 10th grade, but had to give up when she was sick all the time. The family reported it in a concern report to the municipality in 2011. She had to end work, as it was too exhausting for her as well. She no longer had the energy go out to the stables, being with her friends and could no longer play football or other physical activities, as these things always trigger significant deterioration of all the symptoms she has. From being a healthy energetic girl, her life has been completely debilitating. She has been sick for the last 4-5 years now. The HA has requested patient''s physician medical confirmation and reply is awaited. Upon medical review the company judged relevant to code the following adverse events: her mind might play her tricks to believe that she is sick (onset date not reported) and lost muscle mass (onset date 11-Feb-2009). The patient had received the second dose (batch number not reported, vaccination date not reported) and the third dose (batch number not reported, on 12-Aug-2009) of GARDASIL. At the time of reporting, outcome of all AE were not recovered except for that her mind might play her tricks to believe that she is sick and lost muscle mass, which were not reported.
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