Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Blood human chorionic gonadotropin negative, Computerised tomogram head, Computerised tomogram normal, Convulsion
Clinical narrative: Information has been received from a physician concerning an approximately 17 year old female who in 2007 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot# not reported). The physician reported that the patient had been experiencing syncope episodes after receiving GARDASIL in 2007. Two days after receiving her first dose of GARDASIL, the patient experienced her first syncope and was admitted into a hospital. The hospital name and the length of stay were unknown. The patient was currently seeing doctor and being treated with "seizure medications." The patient finished the 3 doses GARDASIL series. At the time of reporting, the patient was recovering. Additional information has been requested. The Health Care Professional contacted during telephone follow-up could not supply the following information: dates of vaccination/therapy, lot numbers, date of event, hospital name. No further information is available at this time. Follow up information has been received from a physician via medical records. On 23-OCT-2007, at 02:30 pm the patient who was home schooled, and non-smoker and did not use illicit substances with depression, frequent headache, and allergy to sulfa and BACTRIM, amoxicillin and AUGMENTIN, and erythromycin, seasonal allergy, and a medical history of tonsillectomy, and with a family history of asthma (mother) and thyroid cancer (father), and with an infected ingrown toe nail in the right big toe at the time of vaccination, was vaccinated with the first dose of GARDASIL (lot# 659435/1265U), intramuscularly in the left deltoid. On 22-FEB-2008, at 02:50 pm, the patient was vaccinated with the second dose of GARDASIL (lot# 659962/1740U), intramuscularly in the left deltoid. On 09-JUN-2008, at 03:05 pm the patient was vaccinated, with the third dose of GARDASIL (lot# 660391/0063X), intramuscularly in the left deltoid. Concomitant therapy included ZYRTEC, LEXAPRO and ZANTAC. The physician reported that the patient had a headache on 24-OCT-2007. The physician reported that the patient noted that the pain was in the frontal aspect of her head, very similar to headache she had frequently. The patient did not take anything for the pain. She was in her usual state of health. On 25-OCT-2007 at approximately 05:00 p.m. the patient got into her car later in the afternoon/evening and turned the car around and placed the car in drive and then could not recollect the next several minutes. The next thing the patient knew was in her neighbor's yard and had destroyed their mailbox. No witnesses were available. The patient came around fairly quickly without a postictal-type phase. The patient complained of neck pain. The patient was able to call her mom and they sought medical attention through the ER. The physician's review of systems included decreased appetite and some minimal cough. No abnormal findings were noted at the physical examination. The physician reported that the impression/plan were: syncope, possible vasovagal in relation to her headache pain. He would continue to monitor on telemetry monitors, check and MRI and MRI of her brain, await patient's echocardiogram and evaluate an EEg. The physician also reported that he would follow the patient's orthostatic blood pressures and possible tension-type headaches. Again await MRI/MRA studies. The patient was admitted to the telemetry unit. The patient's heart rhythm remained stable, and was regular while monitored. The patient underwent workup including: CT of the head without contrast which was normal; MRA of the head was negative; MRI of the brain was negative; and CT of c-spine without contrast showed no acute fracture or subluxation. An echocardiogram showed trace tricuspid regurgitation, otherwise normal echocardiogram. The ejection fracture estimated was between 55 and 60 percent. An electroencephalogram was also performed and was abnormal because of short bursts of left temporal sharp activity noted during hyperventilation and also isolated left temporal sharp activity noted. A basic metabolic panel, and cell blood count (CBC) were normal. An ultra-doppler sonography (UDS), urine analysis (UA), and serum beta-human chorionic gonadotropin test (HCG) were performed and the results were negative. The physician reported that he discussed this case with the on call hospital neurologist who recommended starting the patient on TEGRETOL, and titrating up over time. The physician also reported that they would work on getting the patient's evaluated through hospital as an outpatient. On 28-OCT-2007 the patient was discharged home in stable condition. The discharged diagnoses were: syncope, seizure and headache. The discharge medications included: TEGRETOL, 200 mg tab, 1 tab p.o. twice a day for a week, and then 1 tablets in the morning, 2 tablets in the evening for a week and then 2 tablets twice a day, ZYRTEC 10 mg daily, and ZANTAC, 75 mg daily. The patient's discharge instructions included a diet which was to be as tolerated. Activity as tolerated. The patient had been instructed that she could not drive an automobile for the time being. The physician reported that the patient was to follow up at the end of the week. Carbamazepine levels would be drawn and followed as an outpatient. Additional information has been requested. All available medical records will be provided upon request.  9/15/09 Neurological consult records received DOS 11/07/07. Assessment: First-Onset Seizure. Partial loss of consciousness when she had minor car accident. Neurological exam normal.  10/5/09 Neurological consult records DOS 11/7/07 to 3/28/08. Additional Information: Repeat EEG was performed.