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Life Threatening? No
Write-up: Initial and follow-up information has been received from a health professional concerning a 16 year old female with Crohn''s disease who on 15-MAY-2007 was vaccinated in the right deltoid with Gardasil (lot # 657622/0388U). Concomitant therapy included PENTASA. The nurse reported that following vaccination, the patient developed a large, red, swollen, warm and painful area one inch below the injection site. The area was about 10 centimeters wide. The patient was given BENADRYL. The area had improved slightly since BENADRYL was started. At the time of the report, the patient had not recovered. The nurse also reported the experience of other patients with Gardasil (WAES #0705USA03739). Additional information has been requested.
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