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This is VAERS ID 514893

Case Details

VAERS ID: 514893 (history)  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-18
Onset:0000-00-00
Submitted: 2013-11-26
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1537F / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abscess, Acute abdomen, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Aphthous stomatitis, Aspiration bone marrow normal, Asthenia, Bacterial test negative, Biopsy muscle normal, Biopsy skin normal, Blood creatine phosphokinase increased, Blood pressure systolic abnormal, Body temperature increased, Cardiolipin antibody, Cardiolipin antibody negative, Chlamydia test positive, Colonoscopy normal, Complement factor C3, Complement factor C4, Complement factor normal, Computerised tomogram thorax normal, Constipation, Coxsackie virus test, Diarrhoea, Ear swelling, Electrocardiogram normal, Endoscopy normal, Fatigue, General physical health deterioration, HLA marker study, Headache, Hepatitis A antibody positive, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Hypertension, Hypokinesia, Immunology test normal, Infection, Joint effusion, Lip swelling, Lymphadenopathy, Microscopy, Myalgia, Mycoplasma test, Myopathy, Myosclerosis, Nausea, Nerve compression, Neuralgia, Night sweats, Nuclear magnetic resonance imaging abnormal, Oedema peripheral, Oesophagogastroduodenoscopy abnormal, Ophthalmological examination normal, Pain, Pain in extremity, Panniculitis, Paraesthesia, Pulmonary function test normal, Quality of life decreased, Rheumatoid arthritis, Rheumatoid factor negative, Sleep disorder, Ultrasound Doppler normal, Urine analysis normal, Varicella virus test positive, Weight increased
SMQs:, Rhabdomyolysis/myopathy (narrow), Cardiac failure (broad), Liver infections (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity; Immunisation
Preexisting Conditions: Febrile convulsion; Tonsillitis; 11/2006, Musculoskeletal discomfort; 04/11/2007, GARDASIL
Diagnostic Lab Data: 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; body temperature of approximately 38 degrees C; 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 negati
CDC Split Type: WAES1311DEU010666

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


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