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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: Information has been received from SPMSD (Manufacturer Control Number E2014-06987) on 11-AUG-2014. Case received from the Health Authorities, reported to them by a consumer on 06-AUG-2014, under the reference number: ES-AGEMED-105206338. Case not medically confirmed. A 14 years-old female patient (according to the narratives the patient was 16 years-old, probably meaning the age at the time of reporting) received a dose of GARDASIL (batch number not reported), via intramuscular on 15-DEC-2011 and on the same day the patient presented with convulsions, depression, blurred vision, syncope, double vision and dizziness. According to the HA''s narratives the patient received the first dose of GARDASIL on 15-DEC-2011 and she experienced dizziness. After last dose administration (batch number, route and date not reported), convulsions, dizziness and vision disorders appeared, from which the patient had not recovered. According to the email sent to the HAs from the patient on JUL-2014: she was 16 years-old, she received the first dose of GARDASIL on JUN-2012 and she presented with dizziness and with the last dose (administration date not reported) she presented with convulsions and dizziness. According to the comments from the PV department from HAs the patient didn''t report the adverse event to the physician or pharmacist. The patient didn''t receive any treatment in order to improve the symptomatology. There are several discrepancies between HAs narrative and patient''s narrative regarding number in doses and dates. Case reported as serious by the Health Authorities with hospital admission (admission and discharge date not reported), disability and life threatening as criteria. At the time of this report the patient had not recovered from depression, blurred vision, double vision and dizziness. The outcome from convulsions and syncope was unknown. No further information reported.
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