Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Nausea, Syncope, Tremor
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of Gardasil (lot number unknown). The physician also mentioned that the patient fainted after receiving a first dose of Gardasil but did not have a seizure. On 11-JUL-2007 the patient was vaccinated with a second dose of Gardasil injection and fainted. The physician believes that the patient might have had a seizure as well. Medical attention was sought. The patient was watched for a while after the vaccination and was okay to leave. At the time of reporting the patient is was recovering with therapy (unspecified). No further adverse event information was available. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/19/2007, 9/27/2007. Follow-up information was recieved via telephone from a licensed pratical nurse. On 26-Apr-2007 the patient fainted/passed out about 2 minutes for 5 to 10 seconds after receiving the vaccination while checking out at front desk. There was no seizure activity. The patient hit her head on the concrete floor and had a knot on her head (2 x 2) hematoma after the fall. The patient was given an ice pack. She complained of headache. Her blood pressure was 330/90 after the fall and she was given juice. Later her Blood pressure was 118/78 and she was discharged 1 hour later. The patient had recovered from this event. On 11-Jul-2007 (also reported as 26-Jul-2007) the nurse had the patient sit and lean against he wall prior to her second vaccination. The nurse gave the vaccine and within 2 seconds the patietn had vainted and slid downt he wall. "There was no seizure activity" (preivously reported by physician as "might have had a seizure"). The patient was out for about 5 seconds, she was laid down for approximately 30 minutes while being awake and alert. She was given a cold towel and some water. The patient sat up within 5 minutes she passed out again, was laid back down and the nurse called the physician. The patient was alert and was asked if she knew she passed out. She had no recolleciton of passing out. The patient's father went to get the patient a soda. The patient laid down for approximately 15 minutes, then stood and sat for 15 minutes more. The patient then started to feel dizzy, had a headache and tremors, became nauseous and threw up. The patient sat for 5 minutes more and then felt fine and was discharged. After the patient had vomitted she felt fine and was ready to go. The patient had eaten and was not dehydrated. The doctor was informed that the patient does not drink soda only water and this may have been why she got sick. At 5:05 the patient's blood pressure measurement was 100/76, pulse 54 and at 5:15 pulse was 60. It was unknown if the patient had recoverd as the patient did not call to give her status and the doctor's office has not heard from the patient since the day of the vaccination. No further information  is available.