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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a physician and an office manager concerning a 17 year old female with asthma who on 22-DEC-2006 was vaccinated IM, into the left arm, with a 0.5 ml first dose of Gardasil (lot#654540/0800P). It was reported that at the end of the administration the "safety spring plunger snapped back and caused the patient pain." The office manager explained that this incident was due to human error, the physician was unfamiliar with safety mechanism. On 22-DEC-2006, the patient experienced left shoulder pain and difficulty sleeping on her left arm. On approximately 12-FEB-2007, the patient saw an orthopedic surgeon. The patient underwent an X-ray which revealed no bony abnormality. The orthopedic surgeon recommended that the patient go to physical therapy. At the time of the report, the patient had not recovered. The physician considered the left shoulder pain and difficulty sleeping on her left arm to be disabling events. Additional information has been requested.
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