Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Urine analysis, Vaccine positive rechallenge, Vulvovaginal pain, White blood cell count normal
Clinical narrative: Information has been received from a consumer concerning her daughter a 11 year old female with seasonal allergies who on 14-JUL-2009, was vaccinated with a dose of GARDASIL. There was no concomitant medication. The reporter mentioned that the patient experienced severe chest pain, muscle pain and felt sick after her first vaccination with GARDASIL and she recovered in 2-3 days without medical attention. On 15-SEP-2009, the patient was vaccinated with the second dose of GARDASIL and immediately after the second vaccination the patient felt pain traveling through her body, she cried all day for a week, can not sleep, had migraines, muscle pain, back ache, neck ache, stomach ache, felt a pulsing throbbing in her arms, had sleep walks and was rude and nasty at night. The reporter stated that the patient was in the lowest 10% of height and weight for her age. It was mentioned that the patient was now being seen by homeopathic Doctor who was giving her chelation and detoxification, therapy including vitamins. It was also reported that the patient had done some test: urinary, hair sample without results specified and a "Blood work" with a SED (erythrocyte sedimentation) rate high. The patient sought medical attention in office visit. At the time of reporting the patient had not recovered. The reporter also mentioned on 14-OCT-2009 that the patient was still experienced the adverse events. Follow-up information has been received from a Medical Assistant. It was reported that on 14-JUL-2009, the patient received the first dose of GARDASIL (lot number 661703/0651X). On the same day the patient received a dose of ADACEL (Lot # UF452CA). On 15-SEP-2009, the patient received the second dose of GARDASIL (lot number 661846/1312X). On the same day the patient received a second dose of VARIVAX (Merck). It was also stated that on 19-SEP-2009, the patient was seen by doctor with complaints of arm, leg, shoulder and neck pain. The patient had pain in both arms and in the vaginal area. The physician documented "vaccination myalgia". The patient's mother stated that she had given the patient ADVIL and that had helped the patient. The physician suggested that the patient be given ibuprofen but the patient's mother refused to give the patient ibuprofen. A CBC (Complete Blood Cell) count and an ESR (Erythrocyte Sedimentation Rate) test were ordered. On 21-SEP-2009, the patient's laboratory blood tests revealed, ESR 24, WBC (White Blood Cell) count 8.82, and Hematocrit 33.7. On 22-SEP-2009 the physician reported the patient's laboratory test to the patient's mother. The physician stated that the patient's ESR was slightly elevated and all other laboratory tests were normal. It was reported that the patient was in less pain. It was also reported that the patient's mother stated that she was going to transfer the patient to a homeopathic physician. Follow up information has been received from the patient's father. The father reported that his daughter has become very ill since receiving GARDASIL. She had chest pains, muscle cramps and joint pain after the first shot. Immediately after the second shot she became very ill again with chest pain, muscle cramps and joint pain more prevalent. She also suffered from severe headaches, weakness and nights of restless sleep. She also found it hard to concentrate and complaint that her eyes wander off the page while she read. At the time of this report, the daughter's outcome was unknown. No further information is available.