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Life Threatening? No Write-up: Information has been received from a physician concerning a female patient who on 20-OCT-2006 was vaccinated with the first dose of GARDASIL. Subsequently the patient developed severe arm pain at the injection site. At the time of this report, the outcome of the event was unknown. No further details were provided. Additional information has been requested. 01/05/07: This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a physician and a nurse concerning a female patient who on 20-OCT-2006 was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced severe arm pain at the injection site. There was no redness and no swelling. The nurse reported that the pre-filled syringe "popped" when attempting to use it, causing the patient pain. The nurse then used another syringe which "worked fine". At the time of this report, the patient had not yet received her second vaccination. Additional information has been requested. | ||||||||||||||||||||
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