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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a registered nurse concerning her 25 year old daughter who in September 2006, was vaccinated with her first dose of Gardasil, intramuscular injection in "gluteal region". There was no concomitant medication. In November 2006, the patient received her second dose of Gardasil, intramuscular injection in deltoid. On 08-MAR-2007, the patient received her third dose of Gardasil, intramuscular injection in deltoid. On 09-MAR-2007, the patient experienced tenderness at injection site, erythema at injection site, a raised lump size of quarter at injection site and scar at injection site which was described as the skin being discolored and having a different texture with underlying hardness. As of 02-APR-2007, the patient had not recovered. The product quality complaint unit was not involved. Additional information has been requested.
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