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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from SPSMD (manufacturer control # DK1577272925-E2014-01393) in 19-FEB-2014. Case was received from a health professional via the Health Authorities on 14-Feb-2014 under the references DK-DKMA-ADR 22409359 and DK-DKMA-EFO8127. Case is medically confirmed. Primary source was a physician. Case assessed as serious. A 15-year-old female patient (weight, height not reported) with no medical history reported received the third dose of GARDASIL (batch # NJ50800, lot #: 0773X, expired date: 16-JUN-2011) via intramuscular route on 18-Sep-2009. In March 2010, the patient developed tachycardia, breathlessness and palpitations. The patient was a soccer player who did not play in winter. Upon re-start of soccer in March 2010, she cold not play due to the adverse events. Cardiac investigations including medications were given. At the time of reporting, the patient had not recovered. Previous doses of GARDASIL were given via intramuscular route on 12-Mar-2009 (dose 1, batch#, NK36120, lot#: NJ33240, expired date: 30-SEP-2011) and on 29-May-2009 (dose 2, batch # NK05560, lot# 0773Z, expired date: 16-JUN-2011). Toleration was not reported.
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