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Write-up: Information has been received from Sanofi Pasteur MSD (DE-1577272925-E2013-09192) on 22-NOV-2013 as part of a business agreement via a consumer on 12-Nov-2013, additional information received on 14-Nov-2013. Reporting form was received from a health care professional on 21-Nov-2013. Case is medically confirmed. A female patient, received a complete vaccination series with three doses of GARDASIL IM on 11-Apr-2007 (D1, batch-no. NE45050, lot-no. 655376/0572F, 05-MAY-2009), on 11-Jun-2007 (D2, batch-no. NE35170, lot-no. 655101/0513F, exp 01-MAY-2009) and on 18-Oct-2007 (D3, batch-no. NF37110, lot-no. 1537F, exp 15-DEC-2009). In fall 2007 at the age of 14 years, some time between D2 and D3, the patient developed muscle induration affecting the whole body with changing localisation, abdominal cramps and severe watery and foamy diarrhoea, pain with changing localisation, but especially of the back and frequent infections. Recurrent episodes occurred during 2008 and 2009 and the patient''s health deteriorated. Since 2010, the intensity increased and the patient''s quality of life was extremely reduced. During an outpatient consultation on 05-Mar-2010 due to juvenile hypertension diagnosed one year before with systolic blood pressure values fluctuating profoundly between 70 and 230, therapy with BLOPRESS was suggested. ECG and colour Doppler echocardiography on 05-Mar-2010 were without pathological findings. Lab tests on 05-Mar-2010 did not show any signs of pheochromocytoma. Thorax CT on 27-Oct-2010 was without pathological findings. MRI of the abdomen on 04-Nov-2010 was without pathological findings. Lab tests on 08-Nov-2010 showed CK at 1740 U/l. The patient was hospitalized from 17-Nov-2010 to 18-Nov-2010 due to unclear temporary increase of CK, severe fatigue since about half a year, pain localized in various areas and intermittent headache. The patient reported, that her feet hurt after only about 20 min of walking. Towards the evening she regularly suffered from leg oedema up to the middle of the lower leg. The patient experienced a weight gain of 10 kg within 1 year and subfebrile body temperature of approximately 38 degrees C. Furthermore, she reported of diffuse pressure pain on the chest. Medication on admission included candesartan cilexetil and SYMBICORT. 24-hour collected urine test was without pathological findings. Rheumatoid diagnostic revealed normal ranges of complement factor C3 and C4, and overall complement CH50, cardiolipin IgG and IgM were within normal ranges. Microbiological serology revealed Chlamydia pneumonia IgG 303.9 AU/ml (positive), IgA 26.3 AU/ml (marginal positive) and Mycoplasma pneumonia MPP titer <1:40 (negative). Virological serology revealed Coxsackie-virus antibody KBR* titer 1:20, VZV IgG positive, VZV IgM negative, HIV antigen/antibody negative, HAV IgG positive, anti-HAV IgM negative, HBs-antigen negative, anti-HBs $g1000 mIU/ml, anti-HBc negative, and anti-HCV negative. Immunopathology was without pathological findings, p-and cANCA were not evident and there were no signs of connective tissue disease. During the hospital stay malignoma and myositis were excluded. On 04-Jan-2011 the patient experienced severe back pain. An emergency doctor diagnosed a nerve compression. The symptoms improved under TRAMAL and tetrazepam therapy. On 14-Jan-2011, the patient presented to the outpatient ward of a medical clinic with the diagnosis of juvenile hypertension. Sonography of wrists showed a mild effusion in left wrist. Lab tests on 14-Jan-2011 showed leukocytes 15210 1/ul and TSH 2.54 mU/l. It was reported, that since corticosteroid therapy (start date not reported) the symptoms had improved slightly, but the condition was "not good". The patient''s symptoms had improved slightly under corticosteroid therapy (oral prednisolone). A whole body MRI was conducted on 09-Feb-2011 due to increased CK up to 1700 of unknown etiology at the end of 2010, pain in the wrist joint and for examination of the sacroiliac joint. Epifascial inflammatory changes of the torso (lower thorax and abdomen), both lower legs and also minimally of the distal upper legs were detected. There was no sign of muscular, osseous or articular lesions. The patient was hospitalized from 02-Mar-2011 to 09-Mar-2011 due to increased CK of unknown etiology and suspected syndrome of aggravating pain. On admission the patient reported of night sweat as a new symptom. The symptoms were more pronounced during cold weather. She experienced tingling and pain in her fingers for about 10-15 minutes when she was outside. Shortly before Christmas, she also experienced pain in both feet (more pronounced on the right foot) for a couple of days. An MRI of the wrists on 07-Mar-2011 revealed a slight increase in carpal and carpometacarpal joint effusion of the left side. Yersinia serology and QuantiFERON test were negative, bone marrow examinatioin was without pathological findings, and stool examination did not show signs of salmonella, shigella and campylobacter. Sonography revealed submandibular enlarged lymph nodes in accordance with reactive enlargement and several enlarged lymph nodes inguinal on the left side. MRI of the left foot on 09-Mar-2011 showed findings in accordance with panniculitis in the tarsus below the calcaneus and the dorsal part of the fascia plantaris, as a differential diagnosis the MRI signs could have simple be stress-induced. Histological examination of biopsies taken from muscles, fascia and skin of the right lower leg revealed no signs of rheumatoid disease or inflammation and no signs of malignant events. During hospital stay panniculitis was excluded. In the further course the patient had sleep disorder due to cortisone therapy. The patient was hospitalized from 29-Mar-2011 to 28-Apr-2011. Due to suspicion of medication-induced problems (CK elevation) and change of medication from candesartan to amlodipine therapy. Serological testing for rheumatoid factors revealed ASL 165 IU/ml, RF negative, ANA 1:40 (negative), HLA-B27 negative. MRI of the lower legs on 05-Apr-2011 did not reveal any changes and still indicated pre-tibial edema in line with a circumscript pleural effusion but showed a decline of the epifascial changes of the lower limb. Lung function testing was without pathological findings and in accordance with the patient''s age. Microscopic capillary examination did not reveal any pathological findings. Ophthalmological examination did not show signs of rheumatoid iridocyclitits. Currently, there were no signs from either clinical examination, sonography or lab tests for a rheumatoid disease. On 14-May-2011 the patient had an outpatient gastroenterological examination. She had been suffering from nausea for some time, followed by three to four watery stools per day about three to four times a week. The patient gained 16 kg of weight. Esophagus-duodeno-endoscopy did not reveal any pathological findings except for mild C-gastritis. Colonoscopy was without pathological findings. Examination of biopsies taken from duodenum, antrum, corpus and ora serrata on 18-May-2011 showed no signs of celiac disease, Morbus Whipple or lambliasis. Furthermore, there were no signs of mucosal atrophia or metaplasia, no signs of Barrett metaplasia, fungal infection or malignant events. Final diagnosis were with recurrent nausea and diarrhea of unknown etiology and suspicion of rheumatoid disease. On 28-Jul-2011 the patient consulted a gynaecologist for dysmenorrhoea and lower abdominal pain. On 09-Dec-2011 the patient presented to the doctors and suspicion of psoriatic arthritis was established. Rheumatoid factor, ANA, AMA, ACE and HLA-B27 were negative. The family''s medical history revealed psoriasis vulgaris (father) and polyarthritis (grandmother). Therapy with methotrexate and folic acid was started. Additionally she was treated with prednisolone. On 23-Apr-2012 the patient presented to the ER with pain in the lower right abdomen for approximately 3 days and recurrent diarrhoea for the last 8 months. Acute abdomen was diagnosed. The patient was hospitalized from 23-Apr-2012 to 27-Apr-2012 and appendicitis was excluded. On 08-Jun-2012 an endoscopy of the articular capsule due to chronic diarrhoea and constipation was performed and did not reveal any pathological findings. On 18-Aug-2012 the patient presented to the ER for acute neuralgia of the intercostal space. Analgetic therapy was started. On 29-Nov-2012 the patient had experienced swelling of the lips and the ears on both sides the previous night. The patient suffered from an infection since the previous day. Methotrexate had been discontinued three weeks ago, because after initial better health condition under this therapy her condition deteriorated again. The patient was hospitalized from 27-Aug-2013 to 28-Aug-2013 and was diagnosed with a chronic abscess at the furrow of the left thigh. An excision in toto was performed on 27-Aug-2013. On 28-Aug-2013 the patient presented to the endocrinologic policlinic and was diagnosed with myopathy and lymphadenopathy of unknown etiology. Current therapy included torasemide. The patient had been suffering from troubles with her muscles for some time, in form of muscle induration, movement restrictions, pronounced muscle pain in the mornings and loss of strength. Furthermore, the patient often developed oral aptha and abscess formations. The most plausible cause according to the treating physician was a systemic autoimmune disease. In the immunopathological examination on 16-Sep-2013 there were no signs of a connective tissue disease during serological testing. No antibodies in immunoefflorescence analysis and immune diffusion were seen, in particular myositis relevant core antibodies were not detected. Nevertheless this would never exclude the diagnosis since the antibodies can only be detected in 10-15% of the patients. Antibodies against thyroid globulins and thyroid peroxidase were missing. At the time of reporting, the patient had not recovered and was under permanent medical treatment since 2010. CK levels had normalised after an unspecified time. Outcome of swelling of lips and ears not reported. According to the reporter the events were possibly related to the vaccinations. Patient''s medical history included allergy against NSAIDs, Andrews lesion of the right shoulder (Nov-2006) and recurrent tonsillitis during childhood with suspicion of fever cramps. The patient''s family history included psoriasis vulgaris (father), polyarthritis (grandmother), ischemic stroke (2x, mother aged 38), persisting foramen ovale (mother, sister), tachycardia (sister).
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