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Administered by: Private Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a medical assistant concerning a 23 year old female with no pertinent medical history or drug reaction/allergies, who on 8/31/06 was vaccinated IM with a pre filled syringe HPV rL1 6 11 16 18 VLP vaccine yeast (lot 654540/0800F). There was no concomitant therapy. The medical assistant reported that the spring action activated so forceful the needle and spring popped out of the clients left arm and scratched her. It was reported that all the vaccine was administered and that the pts left arm was washed with soap and water. She also reported that the pt did not bleed. No further details were provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/6/2006. Initial and follow-up information has been received from a medical assistant concerning a 23 year old white female with no partinent medical history of drug reactions/allergies, who on 31-AUG-2006 at 2:00 PM was vaccinated intramuscularly in the left deltoid with the first dose of a pre-filled syringe of GARDASIL (Lot # 654540/0800F). There was no concomitant therapy and no illnesses at time of vaccination. The medical assistant reported that "when the needle safety device was activated, it came down so forceful that the needle and syringe popped out of the client''s left arm, struck the patient, and scratched her." The reporter stated that the "syringe deployed as it should have, but was unexpected" by the health care provider. It was reported that the plunger was released before removing the needle from the arm of the patient. The reporter stated that there was no damage noted to the syringe. It was reported that all of the vaccine was administered and that the patient''s left arm was washed with soap and water and a bandaid was placed over the puncture site and scratch. The reporter also stated that the patient did not bleed and taht there was no adverse reaction to the patient. The patient subsequently recovered. No further information is expected.
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