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Life Threatening? No
Write-up: Initial information has been received from a physician concerning a 15-year-old female patient who on 29-MAR-2013 was vaccinated with the third dose of GARDASIL IM injection drug (dose, injection site, and indication not provided). Batch number: 9QN08R and lot number: 0989AA with expiry date 21-JUN-2014. No information on concomitant medication was reported. On 19-SEP-2012, the patient was vaccinated with the first dose of GARDASIL at hospital A. On 29-NOV-2012, the patient was vaccinated with the second dose of GARDASIL at hospital A. On 29-MAR-2013, the patient was vaccinated with the third dose of GARDASIL at hospital A. On 29-AUG-2013, the patient was in a bad condition and presented to the department of orthopedics at hospital B. She had a diagnosis of a posterior cervical pain and was prescribed LOXONIN. On an unspecified date, as the posterior cervical pain did not recover, the patient visited hospital A again. An electrocardiogram was performed, but showed no abnormality. She was prescribed a pain-relief lotion. Around October-2013, the patient experience epilepsy after two months and presented to the department of pediatrics at nearby hospital C. A detailed examination was performed at the department of psychiatry at hospital C, but causality was unknown. The patient was scheduled to visit an epilepsy center. At the time of report on 09-MAY-2014, the outcome of epilepsy was not recovered, and that of posterior cervical pain was unknown. Reporters comment: not provided. The reporting physician did not assess the causal relationship of epilepsy and the posterior cervical pain to GARDASIL. (A psychiatrist at hospital C felt that the causality between epilepsy and GARDASIL was unknown). The reporting physician considered that epilepsy was serious (disability and other important medical event), and did not assess the seriousness of the posterior cervical pain. Additional information has been requested.
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