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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Information was received from regulatory authority (agency# NO-NOMAADVRE-FHI-2016-23150) via SPMSD on 29-DEC-2016. This spontaneous report as received from an other health professional refers to a 14 year old female patient. On 26-SEP-2013, the patient was vaccinated with the first dose of GARDASIL dose 0.5 ml, parenterally for prophylaxis. On 12-DEC-2013 and 08-MAY-2014, the patient received the second and the third dose of quadrivalent GARDASIL 0.5 ml parenterally for prophylaxis, respectively. The girl had been very ill in the last one and a half year from about June 2015. On an unknown day in 2015, the patient experienced chronic fatigue syndrome, photophobia and paralysis. The outcome of chronic fatigue syndrome, photophobia and paralysis was reported as not recovered/not resolved. The events: chronic fatigue syndrome, photophobia and paralysis were considered to be serious: disability. The reporter considered chronic fatigue syndrome, photophobia and paralysis to be possibly related to GARDASIL. Agency has requested additional information. This is a preliminary report. Sender''s Comments: First dose Gardasil given 20130926. Second dose Gardasil given 20131212. The girl has been very ill the last one and a half year; from about 201506. Agency has requested additional information. This is a preliminary report.
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