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Life Threatening? Yes
Write-up: Information has been received from a registered nurse concerning a 15 year old female patient with no pertinent medical history and no known drug allergies or reactions who on 24-SEP-2007 was vaccinated with the first 0.5 ml IM dose of GARDASIL. There was no concomitant medication. In December 2007, the patient experienced blackout episodes and petit mal seizures. On 06-DEC-2007 the patient was vaccinated with the second 0.5 ml IM dose of GARDASIL, and on 07-AUG-2008 the patient received the third GARDASIL. Some time in 2008, the patient experienced grand mal seizures and had been hospitalized multiple times (details of hospitalizations not provided). The patient had been subsequently evaluated by an unspecified neurologist who had prescribed an unspecified anti-seizure medication. Neurological tests were performed with normal results. At the time of this report, the patient''s blackout episodes, petit mal seizures and grand mal seizures persisted. Blackout episodes, petit mal seizures and grand mal seizures were also considered to be disabling and immediately life-threatening. This is one of several reports received from the same source. Additional information has been requested. 3/9/09 Received hospital records for multiple ER & admits: 3/20/2008 FINAL DX: syncopal episode vs anxiety attack Records reveal patient experienced brief episode of syncope while getting ready to travel to hospital for eye surgery she was very nervous about. Exam in ER revealed chewing movement of mouth/lips, shaking of LUE but was awake & alert. Tx w/anti anxiety med, improved & d/c to home. 4/20/2008 FINAL DX: syncope r/o seizure Records reveal patient experienced sudden LOC & fell to ground striking head. Out for approx 5 min w/jerking/seizure activity for short time. Exam in ER was WNL. Remained stable, d/c to home & referred to Neuro. 10/9/2008 Final DX: postictal state, probable seizure PTA; hypokalemia Records reveal patient experienced HA, facial redness & passed out. Remained stable, d/c to home w/PCP f/u. PMH: congenital heart disease w/open heart surgery, lazy eye w/eye surgery, petit mal seizures x approx 6 mo. 2/18-2/19/2009 FINAL DX: No d/c summary dictated. Neuro states recurrent petit mal seizure Records reveal patient admitted by Neuro s/p petit mal seizure activity while at school w/inattention & shaking of RUE. ER exam was WNL. Meds adjusted 2/24-2/25/2009 FINAL DX: no d/c summary dictated. Neuro states recurrent seizure activity, suspect to be petit mal in type, localized & partial. Exam revealed tonic clinic activity of LUE intermittently. Meds changed, d/c to home w/neuro f/u.
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