Age: 17.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Injection site irritation, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with acne and no known allergies who on 25-Jun-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 ml first dose of GARDASIL vaccine (yeast) (lot 657005/ 0314U). On 25-JUN-2007, the patient was concomitantly vaccinated in the right deltoid of pneumococcal vaccine, polyval (MSD). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN LO), benzoyl peroxide and vitamine (unspecified). Post vaccination, the patient developed left arm burning and swelling at the injection site, recovered, and then the same symptoms reappeared one month later. The patient went on vacation after the vaccination, and thought she might have gotten a spider bite in the left arm. The patient subsequently recovered. On 12-SEP-2007, the patient was vaccinated intramuscularly in the left deltoid with a 0.5 mL second dose of GARDASIL vaccine (yeast) (lot 657872/ 0515U). Post vaccination the patient had swelling at the injection site and soreness of left arm. Her symptoms subsided then returned one month later. The patient was seen in the office "a couple of days ago" in October 2007 with left arme soreness, warm to touch, and slight swelling, but no redness. The patient told the nurse the swelling had decreased. The patient was treated with acetaminophen as needed. At the time of this report, the patient was recovering. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007.  Information has been received from a registered nurse concerning a 17 year old female patient with acne and no known allergies who on 25-JUN-2007 at 13:00 was vaccinated IM into left deltoid with a first 0.5 mL dose of GARDASIL (lot 657005/0314U).  On 25-JUN-2007, the patient was concomitantly vaccinated IM into the right deltoid with a dose of PNEUMOVAX (Lot# 655290/0959F).  Concomitant therapy included ORTHO TRI-CYCLEN LO, topical benzoyl peroxide and vitamins (unspecified).  On approximately 25-JUN-2007, the patient initially developed left arm burning and swelling at the injection site which she had recovered from.  On 24-JUL-2007 (approximately 20 to 30 days later later).  The patient's left arm burning and swelling at the injection site reappeared while she was on vacation.  It was reported that the patient thought it might have been a spider bite and never thought it might have been from the vaccination.  On 03-AUG-2007, it was reported that the patient had recovered.  On 12-SEP-2007 at 15:00, the patient was vaccinated IM into the left deltoid with a second 0.5 mL dose of GARDASIL (Lot 657872/0515U).  After the vaccination it was reported that the patient developed swelling at the injection site and soreness of left arm again.  After this vaccination, the patient  contacted the physician's office and was examined.  On approximately 24-OCT-2007, no redness or swelling were found on examination.  The patient told the nurse the swelling had decreased.  However, she did complaint of soreness mid deltoid with and without movement, her arm being warm to touch and slight swelling.  The patient was treated with acetaminophen as needed.  On 04-NOV-2007, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.