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Life Threatening? No
Write-up: Information has been received from a physician and a medical assistant concerning an 18 yr old female with no pertinent medical history or allergies, who on 17Aug06 was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5ml) (lot 653650/0702F). There was no concomitant therapy. Subsequently, on 18Aug06 the pt developed a rash and hives. It was reported that this was not an injection site rash. The pt presented to her physician''s office on 18Aug06 with hives all over her body. She was treated with oral diphenhydramine hydrochloride (Benadryl). It was also reported that the pt went to the ER twice on 19Aug06 and 20Aug06 and was treated with intravenous methylprednisolone sodium succinate (Solu Medrol) for the hives and welts all over her body and was released (it was also reported that the pt was given IV saline). The pt was scheduled to have a follow up visit with her physician within a week. At the time of this report, the pt had not recovered. The rash and generalized urticaria were felt to be other important medical events. Additional information has been requested.
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