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Life Threatening? Yes
Write-up: Information has been received from a health Medical Assistant (N.A.) concerning a 22 year old female patient who is currently sexually active and had a history of thyroid cancer in OCT-2006. On 19-APR-2007 patient was vaccinated IM in left deltoid with a first dose of Gardasil, lot #657617/0384U. Concomitant therapy included LOESTRIN and LEVOXYL. The medical assistant reported that one or two days post injection the patient''s injection site was little red, swollen and puffy. On 23-APR-2007 patient called the office saying she had not felt good since getting the injections. The injection site was no longer red or swollen and she had no fever but her throat was swollen and she was having trouble breathing (unknown time period injections site reaction resolved and new symptoms occurred). The patient was complaining of a stuffy nose, sore throat, ears ache and ringing of the ears. She wanted to "pull her hair out" because of the ringing of the ears. The patient was instructed to go to the Emergency room (ER) or walk in clinic for treatment. The outcome of trouble breathing, ear pain, feeling unwell, nasal congestion, throat was swollen, sore throat and ringing of the ears was not recovered. The reporter considered the event "difficulty breathing" to be life threatening. The reporter felt the events to be disabling because the patient was not able to go to work or school. Additional information has been requested.
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