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Life Threatening? No
Write-up: Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 26 year old female patient who on 14-AUG-2007 was vaccinated with a first dose of Gardasil lot #658222/0927U. Concomitant therapy included ethinyl estradiol (+) Levonorgestrel (SEASONALE). On 14-AUG-2007, within one month of vaccination patient developed injection site soreness, and then passed out for about one minute. She was dizzy and nauseated. She was transported to the Emergency Room via ambulance. In follow up the nurse reported that after patient received her Gardasil injection she turned her back and about 30 seconds later she turned around and the patient''s head had dropped down and she was very stiff, not limp but stiff. She passed out. She was taken to the emergency room (ER) where she vomited. She had a computed axial tomography (CAT) scan which was normal, although she had a hematoma on her head. The nurse said that she did not fall while in the office or anytime before hand that she knew about so she was not sure where that came from. She had an electrocardiogram (EKG) which was borderline abnormal, and she was recommended to follow up with her primary care physician about the EKG. The primary care physician was aware of the patient''s cardiology problem. The patient''s glucose was 126, prothrombin time (PT) 13.0, red blood cell count (RBC) 4.05, everything else was right on the normal border. She was discharged from the ER that same day. Her discharge diagnosis was vasovagal syncope. The nurse''s office was not able to contact the patient since then and was not sure if patient had recovered. The nurse reported that she did not know whether the event was from her Gardasil vaccination, since the event occurred about 30 seconds after her vaccination. The reporter indicated that the patient''s adverse events injection site soreness, passing out, being dizzy and nauseated were disabling. She also believed transporting patient to the emergency room (ER) via ambulance was an intervention to prevent a serious criteria and it was reported as an other medical event. Additional information has been requested.
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