Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Nausea, Pallor, Postictal state, Somnolence, Syncope
Clinical narrative: Initial report was received on 07 September 2011 from another manufacturer, report number WAES 1109USA00146. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with headaches seen by doctor and a normal brain MRI, familial history of seizures (also reported as negative for seizure disorders in family history (FH) and a history of premature birth (8 months gestation), several days in neonatal intensive care unit (NICU), migraines for 1 year, Epstein-Barr viraemia (EBV) last year with increased fatigue since then, nauseated after the first dose of GARDASIL (lot number not reported) and mononucleosis in 2010 who on 25-JUL-2011, was vaccinated IM with the second dose of GARDASIL (lot number 666598/0786Z) into the left arm. Concomitant therapy included the first dose of ADACEL (lot number C3935AA) given IM into the right arm. It was reported that patient was here for nurse visit for her GARDASIL. She complained of feeling tired and dizzy, denied a headache or fever. After she received her GARDASIL, mom witnessed her eyes roll upwards, patient then became limp and her body was twitching for a minute or 2. "I witnessed the second episode." She became pale, diaphoretic, and her eyes rolled up. She then became limp and had some upper extremity twitching for about 10 seconds. She had some drowsiness after this episode. She was oriented and answered questions appropriately. Review of systems (ROS): positive for fatigue, chronic headaches, No fever, no pulm or gastrointestinal symptoms (GI Sx), no rashes. FH: negative for seizure disorders. General: WDW, Slightly Drowsy, Responsive; Eyes: normal; Ears: normal tympanic membrane (TMs); Nose: nasal passages clear Pharynx normal; Neck: supple, no masses, no lymphadenopathy; Respiration: clear to auscultation bilaterally; Cardiovascular (CV): Regular Rate and Rhythm (RRR), normal S1/S2, no murmurs; Abdomen (ABD): soft, nontender, no masses, no hepatosplenomegaly; Genitourinary (GU): not examined; Extremities: normal; Skin: no rashes or lesions. Assessment: Syncope possible seizure disorder immediately after having a GARDASIL. Plan: Pulse oximeter (OX) =100, Glucose, O2 At 2 liters, Paramedics called Plan to hospital and admission to hospital. VAERS report for GARDASIL. Follow up as needed. The following information was obtained through follow-up and/or provided by the government. 28-JUL-2011 hospital records received for DOS 25 to 27-JUL-2011 with diagnosis: vasovagal syncope. Pt presented status post (s/p) tonic-clonic seizures x2. Immediately after vaccination patient complained of nausea, lightheadedness, seeing black spots, temporal headache; eyes rolled back, became unresponsive and limp, whole body shook alternating with periods of limpness for 3 minutes. After episode patient confused for 10 minutes. Pt asked to move to exam table, fell, had tonic-clonic seizure for 1.5-2 minutes; postictal confusion for 15 minutes. Patient to hospital, admitted for evaluation. No further episodes, pt discharged home in stable condition. The listing indicated that one or more of the events required hospitalization. The original reporting source was not provided. The VAERS ID number was 428167. No further information is available. Paramedics call Plan to hospital and admission to hospital." Documents held by sender: none.