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Life Threatening? No
Write-up: Information has been received for Sanofi Pasteur MSD (SPMSD) (manufacturer control number: E2014-09328) on 10-OCT-2014. Case received from a healthcare professional (a pharmacist0 on 08-OCT-2014. Case medically confirmed. A female patient (age not reported) received the first dose of GARDASIL (batch number, route and site not reported) on an unspecified date and after that, date not reported, she presented with neurologic symptoms. These symptoms worsened with each dose administered (number of doses not reported). According to the reporter the patient started with these symptoms one year and a half ago, exact date not reported. At the time of this reporting the patient was in a wheelchair because when she was standing she lost the equilibrium. The patient started with headache and also with some punctual abdominal pain. The patient also presented with: somnolence (onset not reported, she slept for 18 hours/day), gait disturbance and faintness (onset not reported). According to the reporter, the patient''s mother, who is a nurse, considered these adverse events related to the vaccination; although no physician who saw her (including the neurologist) considered it as related to vaccination. The neurologist thought that there was a psychiatric component. The neurologist didn''t provide a diagnosis because he didn''t know any syndrome with these symptomatology. The patient was directed to the psychiatrist but she was discharged from psychiatrist''s ward (it was not reported whether the patient was hospitalized or not). All of the tests performed on an unspecified dates had normal results, including a CAT, except IgA which resulted very high levels. At the time of reporting the patient had not recovered. According to the reporter, she considered the case as serious. Upon medical review the company considered the case as serious with disability and other medically important condition as criteria. No further information was reported.
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