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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control number E2014-08318) on 16-SEP-2014. Case received from Patient Insurance Company via Health Authorities on 11-Sep-2014 under the reference number DK-DKMA-ADR 22680511 and PIC 14-7379. The primary reporter was a lawyer. The case is considered not medically confirmed. A 13-year-old female patient with a medical history of invertebral disc prolapse, bulimia and anorexia, had received three doses of GARDASIL (batch number not reported) via unspecified route of administration in unspecified site of administration of 14-Jan-2009, 11-Mar-2009 and 02-Oct-2009. Later on unspecified date in 2009, she developed pain in arms and legs, seems like flu with tender lymph, fever and shiny eyes, dizziness and feeling of near fainting, tension in neck and shoulders, joint pain in knees, elbows, shoulder, fingers/pain in hip, pale skin, sensation of paralysis in legs periodically/difficulty holding things, swollen lymph nodes in throat with coating smelling bad, pain in back, fever and nausea. On unspecified date in 2001 she developed fibromyalgia. Further, on unspecified dates she developed frequent headache not relieved by medication, exhausted, concentration impairment, trouble remembering, distracted and forgets her appointments, trouble finding words and speaks incoherently, vomiting, clumsy and falls often, sensory disturbance in feet, legs, arms, hands and face: nose, gain of weight immediately post vaccination, about 9 kg, abdominal pain and cramps, decreased appetite with nausea and disgust at smell of food, anxiety with anxiety attacks, hyperventilation, difficulty breathing, periodically, feels like her throat locks, often suffers from tonsillitis, often has bladder infection, light sensitivity, tingling in hands and feet, restlessness in body, and hand tremor, difficulty with high noise causing anxiety or nausea, feeling remote, trouble sleeping, nightmares almost every night, eyes flicker, difficulty reading, foggy vision periodically, restless and difficulty to relax, easily feeling stressed, swelling at vaccinated site during long period ($g6 months), suddenly swollen labia, severe menstrual pain, breasts swelled un-normally quick with painful tension and stretch marks, tendency to melancholia and depression, frequent palpitations, burning feeling of skin, varying in body and mouth, muscle pain, used wheel chair for one year, suicidal thought, genital problems/genital infections, muscle contraction in both feet and nose, very short temper, long term problems with nail, seems like fungus, pain in pelvis, drops a lot of things, cannot swallow, hot flushes and cold sweat. It was reported that the PIC had received the patient''s request for compensation. The PIC has not yet processed/made a decision regarding the case. (These non-processed Patient insurance cases, are from a starting-point, obviously not medically confirmed). It was reported that the patient received treatment with penicillin (other mfr), of swollen lymph nodes in throat, which was not working (dates or dose not reported). The muscle contractions in both feet caused the little toes to point upward, and also muscle cramps at the bridge of the nose. The patient tried to treat the arthralgia with fish oil (results not reported). The patient also received different types of contraceptive pills, to try to alleviate menstrual pain. She develops physical pain when she is feeling sad or tired. She cannot stand up for a long time, as that worsens pain in back and hips. She often suffers from fever and gets hot flushes or cold sweat. Massage is used to alleviate her muscle pain, but can sometimes not be performed due to too much pain. The patient could not take part in regular education during 7, 8, 9 and 10: th grade. A lot of absence, and could not perform all exams. In school she had her own "office chair" in an attempt to decrease her back- and neck pain. She also took regular breaks to rest, and used a desk with adjustable height. She used a wheel chair for more than one year, due to pain and dizziness. She quit her education due to abdominal pain and muscle pain. She got a driver''s license for automatic gear car, as she, due to pain in back, knees and legs, cannot drive a manual shift car. She is not very socially active due to pain and a trip to the mall with friends is very hard both physically and psychologically. She cannot do physical exercise in the same manner as others, and has not participated to Physical education since 8th grade. She cannot participate to class field trips or travel. Normally, she cannot walk very far, approx. 200 m, but on good days a bit further. She needs to sit or lie down on soft surface. Hard surface worsens the pain in back and hips. She can only work a few hours and not every day. That cause pain in back, shoulders and hips, and after she develops tension headache. Too many appointments during one week cause stress and frustration, with worsened nausea and abdominal pain. She is dependent on car, as bus or train is very stressful and causes pain. She seldom uses public transport. She always needs to have a "life line" when she is in social occasions, when she gets severe pain or nausea etc. She has difficulties with daily duties, as she cannot life very much and easily gets tired. Gets slight pain in the back and hips and shoulders by making beds, vacuuming and difficulty cooking because she cannot stand for long. It is hard to hold on to things when her hands are numb. She is at times very sad and has suicidal thoughts-feel that life is taken from her. She has a hard time seeing a future- afraid to have children. Has difficulty staying focused in social contexts, as she does not feel she is present. In the beginning of 2009 she received her HPV-vaccination, and after this the pain in head, neck, shoulders, back and legs start. Her neck and shoulder gets very swollen, and she was told by her physician that she has muscle infiltrations. She develops sensory disturbances in legs, feet, arms and hands, nausea, dizziness and headache. It seems as she has influenza with swollen lymph nodes and she is feverish and pale in skin- the doctors cannot explain why. An MRI scanning performed in June 2009 shows 2 disc prolapses, which still cannot explain all her pain and other symptoms. After this she has a series of hospitalization, many visits to emergency and specialists, without any recovery. In 2011 she was diagnosed with fibromyalgia by a rheumatologist. The patient was also diagnosed with bulimia and anorexia. She tried to start school again in 2013, but had to give up due to muscle- and abdominal pain and further hospitalizations. Still no clear explanations for her pain. She tried to take a job. It turned out that she could work 4-6 hours daily, but often with 1-2 sick days per week. When returning from work she is very tired and needs to rest, often until next day. She started taking a course and the absence is already high. The patient is distracted and has a hard time focusing, so her mother is still accompanying her to all visits to physician. The patient herself fells she has lost her entire youth, which was filled with pain and feeling sick. She feels something was taken from her and she is tired of the fact that there is always something wrong with her. She uses a lot of medication and gets help by many different treatment providers, which can help and relieve some. The patient is sometimes on the edge of giving up, and has sometimes no desire to live. In these periods her mother is there to listen and talk until she is better. She is now seeing a psychiatrist, which seems to be a good help. The patient has a medical history including bulimia and anorexia, unknown if continuing. In June 2009 the patient suffered from invertebral disc prolapse, as MRI scanning showed 3 disc prolapse (coded as part of history, by HA). The patient was at the time of reporting using medication: Acetylsalicylic acid andcodeienphosphathemihydrat (Kodimagnyl), ZOFRAN, PANODIL, KURACID, Magnesia, Imozop sleeping pills, propranolol betablocker, potassium chloride with MOVICOL and ARAX (MFR, doses and dates not reported). Upon medical review the company considered relevant to code hand tremor, which was mentioned in HA narrative, although not coded. At the time of reporting, the patient had not recovered. HA considered the case serious due to hospitalization and disability.
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