Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Shock, Wart excision
Clinical narrative: Was administered Gardasil .05 ml injection in doctor's office. First noticed arm feeling stiff then my hearing became muffled, dizzy, disoriented and severe slurring of speech, hands drew up. The office and my mother were in a complete panic. Lasted for 1/2 hour. Slowly started to return to normal, except for my hearing. Still isn't right. Less than 2 weeks later, vaginal warts appeared. Positive yeast vaginal culture. BX on 5/30/07-mild dysplasia/HPV.  7/18/07-records received. HX papular condyloma. on 8/21/06-note indicated aftr 1st vaccine had a near syncope episode with no LOC. C/O slurred speech tingling in hands. Outbreak of condyloma.  This is in follow-up to report(s) previously submitted on 9/14/2006. Initial and follow up information has been received from a 22 year old (previously reported as 21 year old) female hostess with breast implants and had a history of abnormal pap tests and dysplasia and from a nurse practitioner. on 18-JUL-2006, the patient was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL (Lot# 653650/0640F). Concomitant therapy included ORTHO LO. There were no illnesses noted at the time of vaccination. On 18-JUL-2006, immediately following vaccination, the patient experienced slurred speech for approximately 3 to 4 minutes and reported that "she felt as if her body went into shock". She noted that her "fingers curled into a fist and her fingers and hands stiffened up." She reported that the latter symptoms lasted for approximately 25 to 30 minutes. Also, approximately two weeks after receiving the vaccination, she began to have some pain and stiffness in her upper left arm and shoulder in the same arm she had received the injection. Unspecified medical attention was sought. At the time of this report, the pain and stiffness in the left arm and shoulder had not resolved. The patient also reported that although she had never had any type of genital warts in the past, on approximately 04-AUG-2006 she noted she had small genital warts which were confirmed by her health care professional. In follow-up the nurse practitioner reported conflicting information that "what the patient described was not what she and another nurse witnessed". The nurse practitioner stated that following the injection the patient appeared pale and almost fainted. The patient became "woozy and could not speak clearly". The patient was attended to by both the nurse practitioner and another nurse. The patient experienced near syncope type symptoms "(felt-fainty)" but had no loss of consciousness. The patient was treated with a cold compress. The patient's blood pressure was "fine" noted as 130/80 mmHg. It was reported that the patient did not experience any drop in heart rate, did not loose consciousness, did not seize and did not experience wheezing. The nurse practitioner did not see what she would described as any adverse reactions to the vaccines and described the patient as being "very dramatic". The nurse practitioner reported that there were no adverse events noted "only common side effects". The patient recovered quickly from the events and was noted as "fine afterwards". It was further reported that the patient reported seeing genital warts to the nurse practitioner, however, the nurse practitioner did not feel these were related to the vaccine. Additional information has been requested.