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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) [MFR # IE-1577272925-2016000514] on 29-JAN-2016. This spontaneous case was received from a health authority on 25-Jan-2016 (ref# IE-HPRA-2016-025695). Initial report was received by the RA on 10-JAN-2016 from a member of the public which concerns a 2 year old female patient who experienced Asthenia, Nausea, Headache, Pyrexia, Tremor and Body temperature fluctuation following vaccination with GARDASIL. Concomitant medications: None. Medical history/concurrent conditions: None reported. The patient was vaccinated with GARDASIL on 02-OCT-2015. One week post vaccination, reported as 09-OCT-2015, the patient experienced weakness, nausea, headache, fever, narcotic shakes and unstable temperature. The patient was hospitalised twice as a results and the medical opinion according to the reporter is a viral infection. The reporter added that the patient went from being a very energetic child both at school and sporting events to someone who is just trying to get on with school and without any sporting activities as she is not able at this point in time. Upon internal review the event term "inappropriate age at vaccine administration" and "vaccination error" were added. At the time of reporting the patient''s symptoms were ongoing. The patient outcome was reported as not recovered/not resolved.
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