Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia, Dysphonia, Emotional disorder, Fatigue, Feeding disorder
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 23 year old female patient with a medical history of premature birth, cisterna magna, intracranial calcifications, periventricular hyperdensities and calcifications, hyoglycoracchia, and educational assistance since 2nd grade (verbal tasks were superior to ability to read), and no illness at time of vaccination, received a third dose of GARDASIL (Lot # 653937/0637F) IM, on the right arm, on 13-JUN-2007. First and second doses of GARDASIL were administered on 13-DEC-2006 and 15-FEB-2007 respectively (Lot # not provided). The patient's speech was slurring. At this date patient could not talk, or move her muscles. Patient has eating through a feeding tube. The following information was obtained through follow-up and/or provided by the government. On 22-NOV-2010 hospital records were received for date of service 04 and 10-APR-2008 with a discharge diagnoses of leukoencephalopathy of unknown etiology. Secondary diagnoses: history of prematurity, question of neonatal Toxoplasma, Other viruses, Rubella, Cytomegalovirus, Herpes virus (TORCH) infection with residual ventriculomegaly, absent septum pellucidum, cerebellar hypoplasia and some gray matter heterotopia. The patient complained of progressively increasing dysarthria with word finding difficulties, loss of coordination, and more easily fatigued. Examination: slow hypophonic dysarthric speech, mild weakness in upper extremities deltoids and triceps, MRI consistent with vasculitic picture with multiple strokes or autoimmune demyelinating disorder, or possibly toxic or infectious cause. The patient was discharged home in stable condition with speech therapy. On 29-NOV-2010 Neurology consultant records received for date of service on 29-APR-2008 with diagnostic of 1) progressive neurological deficits marked predominantly by dysarthria, spasticity, and upper motor neuron findings; 2) apraxia; 3) cortical sensory deficits; 4) pseudobulbar affect; 5) cognitive deficits, predominantly attentional and learning; 6) abnormal MRI scan. The patient complained of slurred speech, midsentence hesitation, irregular rhythm and pitch - worse with fatigue, inability to straighten right knee and move right leg, balance difficulty, weight loss, difficulty concentrating, unable to close mouth on resulting in drooling, laughs and cries easily, leg weakness. Examination: cognitive deficits in attention and learning, apraxia, cortical sensory deficits, CN VII deficit with result on facial droop. Difficulty controlling tongue movements, hyperreflexia, spasticity, and difficulty heel walking. The patient was referred for testing. On 29-NOV-2010 speech pathology consultant records received for date of service on 30-APR-2008 with diagnostic of spastic/ataxic dysarthria. The patient seen for symptoms as noted. Additionally reported previous difficulty swallowing -   [Due to memory limitations, the remainder of this text could not be compared.]  lowing - controlled by eating slower and taking smaller bites. On 29-NOV-2010 neurology consultant records received for date of service 03-MAY-2008 and 25-JUN-2008 with diagnostic of progressive neurologic syndrome with imaging changes. Follow up visit revealed additional complaints of increasing difficulty swallowing. Other symptoms ongoing. Additional testing performed. The patient had performed several laboratories, MRIs, and brain biopsies without any results available. The patient presented to ER and was hospitalized. The reporter considered the adverse events to be life threatening, required hospitalization and permanent disabling. A lot check has been initiated. The original reporting source was not provided. The VAERS ID # is 407172. No further information is available. 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 for Biologics Evaluation and Research and was released.