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Write-up: Information has been received from a consumer concerning her 14 year old daughter with seasonal allergies, mild eczema and no drug allergies who on 01-SEP-2010 was vaccinated with the first dose of GARDASIL. Concomitant therapy included ZYRTEC. The mother reported that on 16-SEP-2010 her daughter experienced headache, hives, itching, stuffy nose and inability to concentrate. On 17-SEP-2010, her daughter came home from school with linear welts on her trunk, itching, mild temperature, 99.5 F to 100.5 F and she was not feeling well. The headaches continued but were intermittent and the pain moved around, it was not always in the same spot. The mother reported that she took her daughter to an infectious disease doctor and the physician did blood work for Mononucleosis, Epstein-Barr Virus and results were negative. The mother reported that the physician gave her daughter a Z-PAK and her daughter had been taking ADVIL and TYLENOL but nothing had helped. Mother reported that her daughter continued to intermittently experience headaches, welts, mild fever and inability to focus. Mother reported that she took her daughter to the pediatrician. Follow up information has been received from a pediatrician, allergist and otorhinolaryngologist via medical records which indicated that the patient was a 14 year old white female student with history of hives in June 2010 that lasted 1 week, penicillin allergy, mother''s family history negative and friends with fever. On 01-SEP-2010, the patient was vaccinated IM with the first dose of GARDASIL (lot # 666598/0786Z) at 11:00 A.M. On 16-SEP-2010, the patient developed hives (also reported as 18-SEP-2010), vomiting, and diarrhea and was seen by the pediatrician who stated that the hives resolved within 2 days. On 18-SEP-2010, the patient developed URI symptoms and unknown low grade fever. The patient was treated with AZITHROMYCIN for a sinusitis. Her URI symptoms improved but she continued to complain of difficulty concentrating and fatigue. Allergy tests and laboratory work was normal. On 24-SEP-2010, the patient was worse in the A.M. her appetite was good, the pediatrician prescribed "2 pcks for 48h" of unspecified medication. On 28-SEP-2010 the patient was seen by the allergies referred by the pediatrician, she complained of sore throat for more than 7 days, fever (temperature of 100.5) and difficulty concentrating. it was also reported that the patient had runny nose. Streptococcus test was negative. The patient did not have rash or swollen glands. The patient had cough, abdominal pain no foreign trauma was found. The patient had no pets or animal contact and she had slept away on a summer camp. Upon physical examination no distress was found, it was normal, except by erythematic nose and a node on her neck. The assessment was probable viral syndrome. Laboratory diagnosis test were performed (not results provided). On 13-OCT-2010, the patient was seen by an otorhinolaryngologist who did an endoscopy of the nasal passage way and found her adenoids all full of puss, her nasal passage way was inflamed and clogged. A nasal steroid spray was prescribed and a 14 day course of antibiotic stronger, something like "CEFADIR". The physician thought once this cleared, the patient should have stronger allergy intervention, the patient was told to use ZYRTEC until about 3 weeks. The physician wrote a note to the school asking them to excuse the patient''s absences from school over the last 3 weeks as she had been suffering from chronic sinusitis and adenoiditis aggravated by severe allergy symptoms. The patient''s absences from school over the last 3 weeks as she had been suffering from chronic sinusitis and adenoiditis aggravated by severe allergy symptoms was considered to be a disabling/incapacity condition. Additional information has been requested. All available medical records will be provided upon request.
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