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Life Threatening? No
Write-up: Information has been received from a licensed practical nurse concerning a 15 year old female with a history of ear tube surgery as a child and with no known drug allergies who on 08-MAY-2007 was vaccinated IM with a first 0.5 ml dose of Gardasil (Lot# 654540/1161F). The patient fainted 7 to 10 minutes after receiving the vaccine and sustained a laceration of her lower lip. The laceration was repaired in the office by placement of 4 sutures. On 14-MAY-2007, the sutures were removed, the laceration was completely healed without complication and the patient fully recovered. No laboratory diagnostic studies were performed. No product quality complaint was involved. Additional information has been requested.
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