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Life Threatening? No
Write-up: Information has been received from a licensed practical nurse concerning her 12 year old daughter with a history of diarrhea and chronic intermittent abdominal pain who on 07-NOV-2007 was vaccinated IM in the left deltoid with a 0.5 mL dose of Gardasil (lot # 655165/1425F). There was no concomitant medication. On 07-NOV-2007 the patient "developed muscle pain and weakness with some dizziness following vaccination with Gardasil. The nurse reported that her daughter experienced immediate pain at the injection site and the injection site arm was sore for the next couple of days. It was also reported that her daughter experienced muscle weakness and "muscle bruising" below the injection site about one week after vaccination with Gardasil. The nurse reported that her daughter''s elbow was sore and she could not straighten her elbow. The muscle pain then moved to the other arm 2 to 3 days ago and currently both elbows and upper arms are sore. The patient has also experienced occasional dizziness." At the time of the report the patient had not recovered. The patient''s muscle pain, weakness below injection site, dizziness, injection site pain, weakness and injection site arm soreness and sore elbow and upper arms were considered to be disabling. Additional information has been requested.
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