Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Electrocardiogram normal, Electroencephalogram normal, Emotional distress, Fatigue
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  A 11 year old female with a history of dyslexia, amblyopia, vomiting and abdominal pain (after milk or ice cream) and penicillin allergy and no known pre-existing illness on 12-OCT-2010 was vaccinated with the second dose of GARDASIL (Lot # 666595/0096Z) IM into the right arm.  Concomitant vaccine therapy included live intranasal (cold adapted Ann Arbor master strain) FLUMIST (Lot # 501051P), the first dose of ADACEL (Lot # U3486AA) IM into the left arm and the second dose of MENACTRA (Lot # U3511AA) IM into the left arm.  On 21-OCT-2010 the patient experienced dizziness, syncope, disorientation.  Seizures and syncope with loss of function on left side started on 28-OCT-2010 with hospitalization, headaches, migraines, nausea, vomiting, rash, acne, fatigue, abnormal blood pressure.  The following information was obtained through follow-up and/or provided by the government.  16-NOV-2010 PCP office record and vaccination record received for DOS on 12-OCT-2010 and office visit rec received for DOS on 13-NOV-2010 to 15-NOV-2010.  Assessment: Pseudoseizures.  Patient was seen on 12-OCT-2010.  Assessment: well child.  Plan: screen for celiac disease.  Visit on 03-NOV-2010 for follow up post hospitalization.  Patient reported to have continued episodes involving loss of consciousness, convulsing, hyperventilating, and staring off into space and memory lapses.  Patient also complaint of chest pain and headaches.  Patient reported stressors (some picking on her at school, trouble with best friend).  Neurological exam noted as normal.  Assessment: Pseudoseizures, conversion disorder.  Patient was seen on 15-NOV-2010 with continued complaint of episodes of seizure-like activity and "passing out".  Neurological exam noted as normal.  On 17-NOV-2010 discharge summary, in patient record and ER record received for DOS from 28-OCT-2010 to 29-OCT-2010.  Diagnosis: Pseudoseizure/conversion disorder.  Patient presented with complaint of near syncopal episode at school.  Patient reported similar episode 2 weeks earlier.  CT head ordered and IV started.  In emergency room, patient had episode with eyes closed, non-responsive, entire body shaking side to side, hang grasping sheets, breathing quickly.  Episode stopped when dad tickled her knee which made her smile.  Record noted CT, blood and urine tests normal.  Patient admitted and evaluated by neurology, psychology and physical therapy.  Patient had continued periodic pseudoseizures and family educated as to origin (stressors).  Patient discharged home and to follow up with PCP.  Laboratory results included: CT scan, video EEG, EKG, blood tests, vitals, therapy.  The following information was obtained through follow-up and/or provided by the government.  On 17-NOV-2010 and 18-NOV-2010 records received.  CT head/brain: normal, EEG: normal (normal awake).  The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening.  The events were serious.  The original reporting source was not provided.  The VAERS ID # is 408723.  No further information is available.  A standard lot check has been finalized.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the Research Center and was released.