Information has been received from a nurse practitioner concerning a 24 year old female patient who on 01-JUL-2010 was vaccinated IM with the first dose of GARDASIL (lot # 662765/0821Y, exp 25-JUN-2011). Concomitant therapy included oral contraceptives. On an unspecified date shortly after 01-JUL-2010 the patient experienced hives following first dose. The patient was referred to an allergist. The patient's hives persisted. Follow up information has been received from medical records and a nurse practitioner concerning a 24 year old female with "PCO", no allergies, non-smoker and occasional alcohol user with a family history positive for diabetes (maternal) who on 01JUL2010 at 11:26 AM was vaccinated in the L deltoid IM with the first dose GARDASIL (lot # 662765/0821Y, exp 25-JUN-2011) and on 15-Jul-10 at (an unknown time), experienced idiopathic urticaria on her arms, legs, neck and chest (initially reported as hives). She was treated with BENADRYL, CLARITIN, prednisone and had changed to non-fragrant soaps and detergents with no relief. No illnesses were reported at the time of the vaccination. On 22-Jul-10, the patient's WBC was high at 16.3 K/mm3 and % lymphocytes were low at 8 and on 10-Aug10 her WBC was normal at 9.8 K/mm3 (reference range 3.8-11.1 K/mm3). 24-Aug10: Pt seen by her dermatologist with complaints of hives outbreak present for about 1 month daily lasting from 2-10 hours with no known origin. The hives are not associated with any swelling of the upper eyelids or lips. Patient denied any aggravating factors or history of HSV. The hives started on her thigh and then spread to her truck and both upper extremities. She was seen by several MDs over the past month. She was initially prescribed prednisone 20 mg for 5 days with no improvement. The prednisone dosage was then increased to 60 mg and tapered. According to the patient, once she had tapered the prednisone to 40 mg, the hives started to recur. She was also on ZANTAC and diphenhydramine hydrochloride, which according to the patient, did help the hives for a short while. Her last hives outbreak was 1 day ago. The hives would last for several hours and resolve. During the hives outbreak, she did experience slight tenderness in her joints but did not notice any swelling or inflammation. Patient noted she was on birth control pills, but had stopped taking the birth control pill as of 17-Aug-2010. The patient denied any history of herpetic infection or any toothaches or swelling of her gums. Patient's physical exam of the back, chest, abdomen, both upper/lower extremities did not show any urticarial lesions. Assessment: Possible chronic idiopathic urticaria. Patient was extensively evaluated by her PCP. Her diagnostic tests, including thyroid stimulating hormone, comprehensive metabolic panel, complete blood count, ESR, ANA, serum ferritin, urinalysis, chest x-ray, antistreptococcal antibodies, mononucleosis, as well as screening for chlamydia, treponema, and HIV were all negative. At the time of the consultation, there were no urticarial lesions for biopsy. The patient was started on loratadine and TAGAMET x at least 4-6 wks. Over this period the patient was advised to monitor if she had any episodes of urticaria. Since she had just stopped her birth control pill, she was advised to stay off the birth control pill for at least another 2 to 3 months. There was also a small possibility her urticaria could be related to her birth control pill. She was advised to make an appointment should she develop more urticaria episodes. All available medical records will be provided upon request. Additional information has been requested.