Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Injection site pain, Loss of consciousness, Neurological examination normal, Syncope
Clinical narrative: Information has been received from a consumer reporting on his daughter, a Certified Medical Assistant (CMA), an office manager and a physician's assistant concerning a 14 year old female patient with no pertinent medical history or drug reactions/allergies who on 11-AUG-2010 was vaccinated with the first dose of GARDASIL (dose, route and lot # not provided), on 27-OCT-2010 the patient received the second dose of GARDASIL (dose and route not provided) (lot # 666163/0664Z) and a dose of FLUZONE (lot number UT3666AA). On 18-MAY-2012 the patient received the third dose of GARDASIL (dose and route not provided) (lot # 672233/1561AA). The certified medical assistant reported that the first dose of the vaccine was not administered in the physician's office. The CMA reported that on 18-MAY-2012, about 8 seconds after the third dose of GARDASIL the patient passed out, fell forward off the table and hit her head on the floor. The patient's mother indicated that her daughter complained about soreness at the injection site "this time and the first two times as well" (approximately in August 2010 and in October 2010) and that the patient had had a seizure. The CMA reported that the patient did not experience a seizure and stated that the office manager had filled out a report and might have better information. The office manager was contacted and stated that they were not sure of the patient hit her head on the floor. Two doctors immediately checked the patient and took her vital signs (results of vital signs were not available at that time). The office manager stated that the patient had recovered before she left the office on 18-MAY-2012. The office manager did not have any information about soreness at the injection site after all three doses of GARDASIL. The office manager stated that the Physician's Assistant (PA) in the office might had additional information. The PA stated that soreness at the injection site was not reported to the office. The PA indicated that on 23-MAY-2012, the patient had a follow-up office visit and the results of the exam were normal. On 25-MAY-2012, the PA was contacted in the physician's office and stated that she did not think the patient hitting her head. The patient "came to" quickly. The PA stated that she did not exhibit any neurological symptoms and a neurological exam was normal. The patient did not have any blood work done (also reported as basic blood work performed). In May 2012 the patient recovered from the soreness at the injection site that the patient experienced after the third dose of GARDASIL. The patient's outcome of soreness at the injection site that the patient experienced after the first and second doses of GARDASIL was unknown. Follow up information has been received from a physician who reported that the now 14 year old female student patient with no illness at time of vaccination and not known allergies or diseases was vaccinated with a third dose of GARDASIL (lot # 672233/1561AA) (dose not reported) into right deltoid on 18-MAY-2012 at morning. The physician also reported that on 18-MAY-2012, the patient experienced syncope and possible seizure, the physician described that the patient awake on her own. There were no laboratories diagnostic tests. The patient did not seek medical attention. At the time of reporting, the patient's outcome from syncope and possible seizure events were recovered. Upon internal review the possible seizure was considered to be an other important medical event. Additional information has been requested.