Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test negative, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a consumer concerning her daughter, an 18 year old female with penicillin allergy who on an unspecified dates was vaccinated with the first and second doses of GARDASIL.  The patient did not experience any adverse symptoms after the first and second dose of GARDASIL.  In March 2008, was vaccinated with the third dose of GARDASIL, intramuscular, in the left upper arm.  There was no concomitant medication.  In March 2008, since the patient received the third dose of GARDASIL she developed redness, swelling and tenderness at the  injection site of the left upper arm within hours of receiving it.  The injection site reaction resolved in a few days without treatment.  Since then, the patient has experienced intermittent episodes of widespread hives.  The patient was examined by her primary care physician, as well as an allergist, who both prescribed antihistamines and a short-course of unspecified steroids.  Contact information for the primary care physician and allergist were not provided.  The allergist performed allergy testing, which was negative.  The patient continues to experience the episodes of hives.  The patient is scheduled to be evaluated by a dermatologist on 21-JUL-2008.  No further information available at this time.  Additional information has been requested.  Conflicting follow-up information was received from a physician, who reported that on 15-OCT-2007 the patient was seen and was vaccinate dwith the third dose of GARDASIL. The physician reported that the patient started on therapy with MACROBID for the treatment of Urinary tract infection. The patient called the reporter on 16-OCT-2007 because she had a sweeling near the shot side and some swelling and some other symptoms in her hand. The patient had a welt on her right arm that was approximately 4 cm in diameter right at the injection site. It was raised just a couple of millimeters over the surface. Her hand on that side, right, was a little puffy. The patient was seen by the physician on 16-OCT-2007.    Since this was the third dose of GARDASIL, the physician told the patinet that her series was complete. The physician suspected that the patient may be having a reaction to a chemical , preservative, or protein in the injection. The patient was advised to apply some caladryl or topical BENADRYL and take BENADRYL at night since it was likely to make her sleepy during the day. No additional information is expected.  This is in follow-up to report(s) previously submitted on 8/14/2008; 10/8/2008. Follow up information has been received from physician, concerning the female patient with no illness at the time of vaccination, who on 11-APR-2007 was vaccinated with the first dose of GARDASIL (Lot number 657617/0384U) IM in the right deltoid. On 15-JUN-2007, the patient was vaccinated with the second dose of GARDASIL (Lot number 675622/0388U) IM in the right deltoid and on 15-OCT-2008 with the third dose of GARDASIL (Lot number 0530U) IM in the right deltoid. Concomitant therapy included XYZAL, doxepin hydrochloride and TILIA FE. On 16-OCT-2007, the patient experienced and allergic reaction after the third dose of GARDASIL. After the patient received the vaccine her arm swelled. On the next day, on 17-OCT-2007, the patient developed hips on her hips and developed sore/ulcer in her mouth and in her lips. On 25-OCT-2007 it was reported to the responsible physician and on 26-OCT-2007 the patient sought medical attention at office for evaluation and treatment. On an unknown date, was performed a complete blood cell count, comprehensive metabolic panel, serum immunoglobulin E test, thyroid peroxidase antibody and GGPD and C-reactive protein test (results not provided). The hives was considered to be disabling and an other important medical event by the physician since the patient had hives daily for one year and was currently treated. No further information is available.