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Write-up: Initial and follow-up information has been received from a physician concerning a 12 year old female, who on 23-JUL-2007 was vaccinated with her first dose of Gardasil (lot# 658094/0524U). Concomitant vaccination included Tdap (Lot# AC5213018A13). On 08-OCT-2007 the patient was vaccinated with her second dose of Gardasil (lot# 658558/1061U). On 04-FEB-2008 the patient was seen in the office and complained of a sore throat, headache, and stomach ache. The patient was diagnosed with acute pharyngitis. The physician believed the pharyngitis to probably be viral, but would follow culture to 48hours. The strep ID was negative. The patient was given information on how to treat and what to watch for. On 18-FEB-2008 the patient was seen at the office with complaints of dizziness/vertigo, severe headache, and felt "off balance." The patient was diagnosed with fatigue, lethargy, and a headache. The patient also experienced weight loss. The patient''s head, ears, eyes, nose, and throat (HEENT) was within normal limits, complete blood count (CBC) was normal, serum Epstein-Barr virus antibody test was negative, and blood pressure was 106/60. The patient appeared to be recovering from viral illness. The physician discussed low blood pressure with the patient. The patient was reminded to stand up slow, eat a healthy diet and to call if signs and symptoms worsened or did not improve. On 25-FEB-2008 the patient was seen in the office with complaints of headache, dizziness, and a decrease in oral intake with a 6-10 pound weight loss over the week. The patient''s mother reported that the patient has been sleepy during the week. The patient experienced nasal congestion, and mild pain over frontal sinuses. The patient was diagnosed with headache and acute sinusitis. The patient was prescribed ZITHROMAX TRI-PAK. It was reported that the headache was gone. The patient was advised to take antibiotic with chocolate milk or a meal to help with the upset stomach and to continue the ZITHROMAX TRI-PAK and call with any other problems. On 29-FEB-2008 it was reported that the patient''s sinuses were not better. The patient was prescribed amoxicillin 500mg by mouth for 10 days. On 10-MAR-2008 the patient''s mother reported to the office that the patient''s headache continued. The patient was told to come to the office the next day. On 11-MAR-2008 the patient was seen at the office with continued headache. The patient also experienced a sore throat in the AM, congestion, upset stomach, was very tired, and was losing weight. The patient was currently being treated with amoxicillin and the sinusitis was not any better. The patient was prescribed CEFTIN 250mg 2x daily for 10 days and to continue another 10 days if better. She had unspecified lab tests and the results were unknown. It was reported that the patient''s mother has been researching on the internet and feels that there is a relationship between the symptoms and the possible side effects of the vaccine. She was last seen by the office on 11-MAR-2008 and the patient''s outcome was not recovered (previously reported as was believed to be recovered). The acute pharyngitis, fatigue, headache, lethargy, and sinusitis were considered to be disabling and other important medical events. This is one of two reports from the same source. Additional information has been requested. Medical records are available upon request.
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