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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a physician via a regulatory authority (V13000667) and described the occurrence of schizophrenia in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline) and LEXOTAN (non-gsk). Historic vaccination included 1st and 2nd dose of CERVARIX (GlaxoSmithKline) given on an unspecified date. On 26 January 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). On 2 February 2012, 7 days after vaccination with CERVARIX, the subject experienced abdominal pain and vomiting. On unknown date in 2012, as the symptoms persisted, the subject visited an unknown hospital where she was treated with Bio-Three, CEREKINON and LEXOTAN. On an unknown date, abdominal pain was improved but sleepiness, malaise and reduced thinking appeared. The subject received LEXOTAN for 1 or 2 weeks. The subject''s mother was informed regarding effects of LEXOTAN and was anxious. On unknown date after treatment with LEXOTAN was discontinued, sleepiness, malaise and reduced thinking persisted. On 19 June 2012, the subject visited the department of psychiatry at hospital A. The subject was diagnosed with schizophrenia and was prescribed neuroleptic (Anti-psychotic medication) medicine. On 20 September 2013, the subject was attending hospital A for treatment. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, schizophrenia, thinking reduced were unresolved and abdominal pain was improved. The outcome of other events was unknown. The causal relationship to CERVARIX was unknown.
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