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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-1577272925-2016001229) on 16-FEB-2016. This case was received from the HA on 12-Feb-2016 with reference number IE-HPRA-2016-025854. Initial report was received by the HA on 28/Jan/2016 from a member of the public which concerns a 13 year old female patient who experienced Depression, Panic attack, Insomnia, Anxiety disorder and memory impairment following vaccination with GARDASIL. Concomitant medications: None/ Medical history/concurrent conditions: None. The reporter indicated that the patient was 100% perfect. The patient was vaccinated with three doses of GARDASIL (batch numbers GOO5669, GOO5669 with expiration date: 31-JUL-2013, G0014502) in 30/Sep/2011 and 23/Mar/2012 (only two dates provided). Post vaccination, reported as 30/Mar/2012, the patient experienced depression, panic attacks, difficulty sleeping, anxious and memory lapse. Upon internal review the batch number GOO5669 was corrected to G005669. The events of Depression, Panic attack, Insomnia, Anxiety disorder and Memory impairment were considered to be serious as other medically significant condition and disabling/incapacitating. Corrective treatment: Medication, reflexology, counseling etc. At the time of reporting the patients'' symptoms were persisting. The patient outcome was reported as not recovered/not resolved.
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