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Life Threatening? No
Write-up: Information has been received from a physician via SPMSD as part of a business agreement (Sender''s case report number DK-1577272925-E2014-00144) on 13-JAN-2014. Case of adverse event received from a health care professional via Health Authorities on 09-Jan-2014 under the reference number DK-DKMA-ADR 22377196 and DK-DKMA-EFO7893. The primary reporter was a physician. A 13 years-old female patient (weight: 58 kg; height: 167 cm), had received the third dose of GARDASIL (batch number NM46920, lot number NK47540, exp. 31-MAY-2012) via intramuscular route of administration in not reported site of administration on 04-Feb-2011 and later on, unspecified date in Feb-2011, she developed narcolepsy. In addition, on an unspecified date after the third vaccination, she developed persistent tiredness and three months later she experienced narcolepsy with cataplexy (hypocretin deficiency). Patient medical history is unknown. The patient had received two previous doses of GARDASIL (batch numbers are unknown and cannot be provided) via intramuscular route of administration in not reported site of administration on 05-Jul-2010 and 02-Sep-2010. It is unknown if the patient had other vaccines or medications. Test of spinal fluid showed low hypocretin (<10) HLA-DQB*0602. Polysomnography and MSLT (multiple sleep latency test) showed short average sleep latency (30 seconds). SOREM (sleep onset REM) was in 4 out of 5 periods. At the time of reporting, the outcome was unknown for persistent tiredness and narcolepsy with cataplexy. Outcome was not recovered for narcolepsy.
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