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Administered by: Private Purchased by: Public
Life Threatening? No
Write-up: This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow-up information has been received from a physician concerning a 12 year old female with no known drug allergies, plantar warts on hand/fingers at the time of vaccination and a history of gastrooesophageal reflux who on 18-APR-2007 at 16:15 was vaccinated with intramuscularly into the right deltoid with a first 0.5 mL dose of GARDASIL (lot #654535/0960F). Concomitant therapy included VARIVAX given at the same visit using a different site. On 23-APR-2007 at 07:00 (also reported as "a short time after the vaccination"), the patient developed swelling and pain in the fingers of the hand near the pre-existing plantar warts on the hand of the arm in which she received the GARDASIL (also reported as swelling in both of her hands but mostly in the right). The patient sought unspecified medical attention. No laboratory diagnostic tests were performed. The symptoms resolved over 5 days and "are now gone." No further information was provided. No product quality complaint was involved. Additional information is not expected.
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