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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MFR Control Number E2015-08831) on 03-AUG-2015, as a part of business agreement. Case received from Health Care Professional via Health Authorities in a foreign country on 30-JUL-2015 under the reference numbers DK-DKMA-ADR 23084495 and DK-DKMA-WBS-oooo521. The case is medically confirmed. The primary reporter was a physician. A 15-year-old female patient, with a medical history of mononucleosis and recurrent pseudomonas infection, had received the third dose of GARDASIL (batch number not reported) via i.m route of administration in unspecified site of administration on 04-NOV-2009 and later on 15-NOV-2011, she developed tiredness, sleep disturbance, hand tremor, feeling cold and leukocyturia. The patient has undergone HPV vaccination x3 in 2009. The case is serious due to seriousness criteria disability. No other medication or vaccines. Numerous examinations have been performed: CT and ultrasound of the urinary tract, blood tests, urine test and cultures due to recurrent pseudomonas infections in the face. None of the examinations have been able to explain the patient''s unspecific symptoms. The patient is examined at Urological department (hospital), they found in all urine tests that were taken more than 500 leukocytes per ml urine. They evaluated the patient for tuberculosis. The investigations have ended and it was concluded that it was nothing abnormal. Currently under evaluation at infection medicine department (hospital) and rheumatological department (hospital). The patient is referred to Syncope Center (hospital). (not further specified). Previous doses of GARDASIL (D1-D2, batch numbers not reported) were given via i.m route of administration in unspecified site of administration on 24-APR-2009 and 03-JUL-2009. At the time of reporting the patient had not recovered.
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