Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Lymphocyte count normal, Mean cell volume normal, Mean platelet volume normal, Mouth ulceration, Neutrophil count normal
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2007. Information has been received from a consumer concerning her 14 year old daughter with seasonal allergies and patellofemoral syndrome  who on 12-JUL-2007 at 7:37 pm, was vaccinated IM in the right arm with a first dose of GARDASIL (Lot # 658100/0525U). Concomitant suspect therapy included a dose of Boostrix and a dose of Menactra. "Within 48 hours after receiving the vaccine", the patient developed ulcers in her mouth. Unspecified medical attention was sought. It was reported that the patient was advised to visit the infectious disease department in order to treat the ulcers in her mouth. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Initial and follow up information has been received from a nurse concernign a 14 year old female student with no known allergies, who on 12-JUL-2007 at 19:37, was vaccinated IM in the right arm with a first dose of GARDASIL (Lot# 658100/0525U). Concomitant suspect vaccination included a second dose of VARIVAX (Oka/Merck) (Lot# 657652/0606U) administered subcutaneously in the left arm. Concomitant vaccinations included a dose of BOOSTRIX and a first dose of MENACTRA (Lot# U2227AA) administered intramuscularly in the left arm. There were no illnesses at the time of vaccination. "Within 48 hours after receiving the vaccine", the patient developed ulcers in her mouth. On 16-JUL-2007 at 18:11 the patient was seen in the office and had developed white patches in her throat, however her throat was not sore. The actual onset was 1 to 2 days prior to office visit. It was reported that the patient was advised to visit the infectious disease department in order to treat the ulcers in her mouth. On 18-JUL-2007 the patient was seen in the emergency room for evaluation of white patches. A culture provided Candida. The patient was treated with ROCEPHIN and nystatin oral suspension. On 17-JUL-2007 a series of laboratory diagnostic tests were performed (see lab section for results). The patient was scheduled to see an allergist/immunologist. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. It was noted that on 06-SEP-1997 the patient was vaccinated SC in the left arm with a second dose of VARIVAX (Merck) (Lot# 657652/0606U). Additional information is not expected. Follow up information received from the physician indicated that on 14-JUL-2007, the patient developed "white lumps" in her throat. On 16-JUL-2007, the patient visited the physician's office with "white papules on uvuls and soft palate," but no exudate and "non-monillial." The patient did not have a sore throat nor cervical adenopathy and felt well. The physician diagnosed acute pharyngitis, prescribed nystatin for presumptive thrush and instructed the patient to gargle with salt water that night. On 17-JUL-2007, the physician contacted the infectious disease department at the hospital and the patient was seen in the ER. The ER physician questioned an allergic reaction and an extensive workup was done, including culture and blood work. The patient then complained of soreness in her throat. Treatment included an IM dose of Ceftriaxone in the ER. All blood work and diagnostics were negative or normal with the exception of a positive fungal culture of the oropharynx for candida albicans. She was diagnosed with acute pharyngitis and discharged with nystatin oral suspension, prescribed four times daily for 7 days. At the time of this report, the outcome of the events was unknown. Additional information has been requested.