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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: This spontaneous report has been received from a pharmacy student referring to a 15 year old female patient. The patient did not have pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies. On an unknown date, the patient was vaccinated with the first and second dose of GARDASIL (strength, route of administration, frequency, lot#, and expiration date were unknown by the reporter) for prophylaxis. On 16-JAN-2017, the patient was vaccinated with a third dose of GARDASIL (strength, route of administration, frequency, lot#, and expiration date were unknown by the reporter) for prophylaxis. On 16-JAN-2017, reported as "immediately after the third dose", the patient experienced in the vaccinated left arm and fingers pain and tingling for a month. The pain did not resolve and became worse. Therefore on an unknown date a nuclear magnetic resonance imaging (MRI) was performed and "showed inflammation". The pharmacy student also reported that the "pain spiked to 10 out of 10" and the patient could not use her arm, the reporter suspected that the patient could have osteomyelitis. The patient went to the emergency room on an unspecified date and then on 19-FEB-2017 the patient was hospitalized in a local hospital for control the pain, the patient''s treatment included TYLENOL, TORADOL and morphine. At the time of reporting the outcome of pain and tingling in her arm was not recovered and the outcome of osteomyelitis and inflammation was unknown. The reporter stated that the osteomyelitis, pain and tingling in the patient''s arm cause disability. The relatedness between the events and GARDASIL was not reported. Upon internal review osteomyelitis was considered to be a medically significant event. Additional information has been requested.
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