Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood glucose increased, Compression fracture, Computerised tomogram normal, Convulsion, Electroencephalogram abnormal
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 16 year old female with a history of dislocated shoulder, irregular periods, migraine and appendicectomy who on 17-MAR-2008 was vaccinated in right arm with the first dose of GARDASIL (LOT# 659653/1448U). On 19-MAY-2008 the patient was vaccinated with the second dose of GARDASIL. The patient did not have the third dose of GARDASIL. On an unknown date, the patient stated she had twitching spells after awakening. The reporter thought that it was just might be the way the patient was sleeping because it did not happen everyday. On 15-AUG-2008 the patient had a major seizure and was admitted to the hospital. She was diagnosed with epilepsy. She had 5 major seizures since and saw a neurologist on a regular basis. The patient was diagnosed with Juvenile myoclonic epilepsy. She took LAMICTAL 300 mg twice daily. The patient had regular electroencephalography (EEG). There was no history on either side of the family of a seizure disorder and she had never had any seizure history and no major illnesses. Neurologist commented that this might affect her for the rest of her life. Since 15-AUG-2008 the patient was tested on regular basis. EEGs showed abnormal which were consistent with seizure disorder. EEGs were done in 5 or 6 times and only the last 2 had shown normal with medication. The result of Computed axial tomography brain was negative. White blood cell count was 18 and blood sugar was 119. Shoulder x-ray had a positive result of dislocation and compression. On 29-SEP-2009 medical record was received for date of service on 15-Aug-2008 and 16-Aug-2008 with discharge diagnosis of seizure activity, right shoulder dislocation and syncope. Patient presented after witnessed seizure activity. She found passed out in bathtub. Patient dislocated/fractured her shoulder during the episode. It was also reported pre-syncopal episodes for 6 months. On 02-OCT-2009 neurology consult records were received for date of service on 14-SEP-2009. An assessment for Juvenile myoclonic epilepsy was done. Seizures occurred upon awakening and initial myoclonic jerks was reported. Compression fracture, epilepsy, joint dislocation, loss of consciousness, muscle twitching, myoclonic epilepsy, myoclonus, presyncope, syncope and convulsion were considered to be disabling and to be immediately life-threatening. The patient required an emergency room visit. The original reporting source was not provided. The VAERS ID # is 357365. A lot check has been initiated. Follow-up information was received for lot check result. A standard lot check investigation 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 Center. No further information is available.