Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Syncope, Tinnitus, Vaccine positive rechallenge, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 07-NOV-2006 was vaccinated with the first dose of GARDASIL. On 12-JAN-2007, was vaccinated with the second dose of GARDASIL. On 16-MAY-2007, was vaccinated with the third dose of GARDASIL. On approximately 12-JAN-2007 after the second dose of HPV vaccine, the patient fainted. On approximately 16-MAY-2007 after the third dose, she also fainted. She has had subsequent fainting of approx. 10 times within the last 2 years. She also suffered of anxiety and fatigue syndrome. She came to the doctor's office on 31-AUG-2009, for blurred vision and fainting spells. The patient's outcome was unknown. Follow-up information was received from a physician via medical records indicating that the 14 year old female student with allergy to CLEOCIN and a history of tonsillectomy and adenoidectomy (twice at age of 5 and in 2008), jaundice and spinal meningitis at 10 months of age (At that time, she was admitted to the hospital for 1 week and treated for IV antibiotics) was vaccinated in the left arm with the first, second and third dose of GARDASIL on 07-NOV-2006, 12-JAN-2007 and 16-MAY-2007, respectively (Lot # of the first and second dose: 654389/0961F). There was no illness at time of vaccination. There was no other concomitant medication. It was reported that the patient was a product of vitro fertilization and born 1 1/2 month premature by vertex vaginal delivery with birth weight  5 lbs and 8 ounces. She underwent a normal cardiac workup at age 3 for murmur. It was reported that the patient experienced syncope episode approximately 10-15 minutes after receiving the vaccine and 10 more periodic episodes of syncope "over the past 2 years". Neurological evaluation and cardiovascular evaluation were within normal limits. She was diagnosed with vasovagal syncope. It was reported that the patient never had syncope episodes prior to the vaccination. On 31-AUG-2009 the patient was seen by the physician. Her chief complaint included fatigue, blurred vision (like "fade to black"), cold sweat, lightheaded (random episodes per 1 months, 3-4 episodes every weeks, no new medications), fainting proceeded by dizziness (present and admits passing out, 2-3 times in the past month, occurs random times, can be sitting on the couch, feels ok after passing, eating well). Physical examination was normal. EKG was normal and incomplete RBBB otherwise normal. Post blood sugar was normal and 101. Hemoglobin in office was normal and 11.7. The diagnoses included syncope and collapse: etiology possible rule out seizure disorder vs vaso-vagal reaction (the latter most likely) and mile anemia (not enough to cause syncope). The patient was referred to neurological evaluation and encouraged high iron foods and a multivitamin. At that time the patient's problem list included anxiety disorder, nummular eczema (per dermatologist in April 2009), irritable bowel syndrome (2006) and dysmenorrhea. She was taking ETODOLAC 400 mg twice a day from 19-FEB-2009 and LEXAPRO 10 mg daily from 08-OCT-2008. On 01-OCT-2009 the patient was referred for neurological evaluation. The patient stated that her fainting spells started after receiving GARDASIL about two years ago. The mother however indicated that her daughter had always fainted when she got a shot but since she got GARDASIL vaccination the fainting spells had been much more frequent and occurred without receiving any shots. The patient stated that she had GARDASIL shot given in her left upper arm and she did not faint at that time. Her fainting spells were more frequent during the last 6 months. During and average spell the patient got dizzy and lightheaded. She felt cold and would be sweaty at the same time. Her vision would fade to black. Her ears felt plugged and would start ringing. The patient stated if she lied down she would be OK. If not she would pass out for about a minute or so. Then she woke up and went on to do things normally.  There was no history of associated tongue biting, no urinary incontinence. The mother stated her daughter would tell her "mom I'm gonna faint" then she would lean on her mom and fall and pass out for about a minute. Her eyes rolled back a little bit. She would be very pale and limp. There was no shaking or twitching, no incontinence, no tongue biting. Afterwards she knew what happened and she got a little embarrassed. Otherwise she would be fine. Her last episode was about 1 1/2 weeks ago. It happened shortly after she had her blood drawn. She walked out of the elevator then she passed out. Someone saw and called 911. Paramedics came. She was fine. They took her blood pressure and released her to her father who was paramedic. They did not take her to the hospital. The patient stated she had 3-4 fainting spells during the month of September 2009 and had over 15 fainting spells within the last 6 months.  Review of systems was positive for headaches. The patient stated her headaches were sometimes occipital, sometimes bilateral temporal, sometimes were frontal. The patient described a non-throbbing constant pain. On a scale of 1 to 10 with 10 being the most severe, the patient rated the intensity of her headaches at "6.5". There was no history of nausea or vomiting and no history of any associated visual disturbance. The patient stated her headaches would last anywhere from a few hours to the whole day. She had been having these headaches on an average of 2-3 times per week. The patient stated she had chronic headaches off and on for a few years but the headaches were much more frequent during the last 2-3months. The mother stated that the patient had some "twitches" for many years. The patient stated it was "a bad habit". Physical examination was normal. The neurologist's impression included: 1. recurrent syncopal episodes, etiology was uncertain but could be vasovagal syncope however other etiology such as seizure disorder, over the last years increasing in frequency over the last 3 months, this could be childhood migraines however other more serious etiology such as brain tumors, other intracranial space occupying mass lesions, while all were felt to be less likely can not be ruled out entirely on clinical grounds. Electroencephalogram on 08-OCT-2009 revealed essentially normal for age sleep deprived electroencephalogram (EEG) recorded during the awake state and including three minutes of hyperventilation without any evidence of focal features or clear cut paroxysmal activity. But it was reported that a normal EEG did not exclude seizure disorder, clinical correlation was advised. On 20-OCT-2009 the patient was referred to cardiology evaluation. It was reported that the patient had syncope "at least" 10 times in the last 2 years since her GARDASIL vaccination. Typically she would felt could and sweaty with ringing in her ears followed by loss of consciousness. She would recover shortly thereafter without much residual deficit. Physical examination, EKG and labs were normal. The cardiologist's impression was vasovagal syncope. No additional diagnostic or therapeutic measure's needed from a cardiac standpoint. Follow-up information was received from a physician via medical records indicating that on 14-OCT-2009, magnetic resonance imaging (MRI) of the brain showed that normal MRI of the brain. Additional information is not expected.