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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a certified medical assistant concerning a 21 year old female with a history of menstrual migraine who on 08-JAN-2007 was vaccinated with her first dose of Gardasil (lot # 655165/1425F). Concomitant therapy included duloxetine hydrochloride (CYMBALTA). On 08-JAN-2007 the patient experienced redness of the arm and itching at the site of injection, which spread to itching around the injection site. The patient also had pain radiating down the right arm for a few weeks. Unspecified medical attention was sought. Subsequently, the patient recovered after 3 weeks. The medical assistant also mentioned that the patient had been vaccinated on 09-Mar-2007 with her 2nd dose of Gardasil (lot# 656372/0243U) and received less than 1/2 the normal dose for reason unknown. It was reported that the injection site was immediately itchy. No product quality complaint was involved. Additional information has been requested.
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