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Life Threatening? No
Write-up: Information has been received from a registered nurse concerning a female who on 06-JAN-2007 was vaccinated with a first dose of Gardasil (yeast) (0.5 ml), intramuscularly. On 06-JAN-2007 the patient had a lump at injection site. It was reported that one month later the patient still had lump at injection site. Unspecified medical assistant was sought. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. The physician felt that the adverse event occurred due to "placement" versus the GARDASIL. The physician also mentioned to the nurse that the vaccine might have been administered "too far over on the leg". In follow-up, the registered nurse reported that the physician decided that the vaccine was given in an incorrect site in the thigh and confirmed that it was an administration error rather than a vaccine adverse event. Additional information is not expected.
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