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Write-up: Information has been received from a physician concerning a 15 year old female who on 07-DEC-2006 was vaccinated intramuscularly with a second dose of GARDASIL. On 07-Dec-2006 the patient experienced significant arm pain, including through the passive motion. The physician reported that the patient was sent to see an orthopedic physician on 03-JAN-2007 because the patient was a dancer and could not dance with extreme pain. At the time of this report, the outcome was unknown. It was also reported that the patient was vaccinated with a first dose of GARDASIL on 12-OCT-2006 and there was no adverse experience with this initial dose. No product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up informtion has been received froma physician and medical records concerning a 15 year old female who on 07-DEC-2006 was vaccinated intramuscularly with a second dose of GARDASIL vaccine (Lot number 653938/0954F). On 07-DEC-2006 the patient experienced significant arm pain, including through passive motion, limitating activities. The patient was again seen in the physicia''s office on 14-DEC-2006 still with "arm hurting". During physical examination, it was noted that the patient had a "small 1 cm greenish older bruise with no palpable mass in the deltoid area". The patient was treated with ALEVE, 2 tablets orally twice a day as necessary for pain. The patient returned to the physician''s office on 20-DEC-2006 still with "arm sore, still unable to move to do some dance" (previously reported as could not dance with extreme pain). Physical examination noted the deltoid area with no palpable mass, tenderness to palpation by report but with no wincing or guarding, and slight hyperemia". The physician referred the patient to an orthopedic physician. The patient was seen in the orthopedic physician''s office on 04-Jan-2007. According to the orthopedic physician''s office notes, the patient''s pain was localized to the injection site over the mid aspect of the deltoid muscles. This pain was associated with any overhead lifting and some weakness. There was no pain with rest. An x-ray of the shoulder are showed no evidence of bony abnormalities or myositis ossificans. The orthopedic physician''s assessment was that the patient had "a little residual irritation from the injection site, and the pain may be associated with some residual muscle spasms". The patient was prescribed FLEXERIL. It was also reported that the patient was vaccinated with a first dose of GARDASIL vaccine on 12-OCT-2006 and there was no adverse experience with this initial dose. Follow-up received on 7-FEB-2007 contained the following adverse experiences: rotational scoliosis (4-JAN-2007), and pharyngitis (20-DEC-2006). Additional informatinis not expected.
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