Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Encephalitis, Laboratory test, Lethargy, Musculoskeletal stiffness, Neck pain
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. On 08-JUN-2007, a 12 year old female with a history of idiopathic thrombocytopenia purpura (ITP) was vaccinated with the first dose of GARDASIL (route and vaccination site not reported) and a dose of VARIVAX (Merck) (route and vaccination site not reported). Concomitant therapy included MENACTRA given also on the same date. On 16-AUG-2007, the patient was vaccinated with the second dose of GARDASIL via intramuscular route into her right arm (lot # 658488/0930U). The patient was diagnosed with encephalitis etiology unknown. Five weeks after administration the patient experienced stiffness of neck, neck pain, back pain, lethargy, no appetite fever for 7 days, then began having seizures which lead to respiratory failure. 1 1/2 year later seizures are ongoing and numerous developmental problems due to brain atrophy. On 13-MAY-2009, the patient's records were received which concern her emergency room (ER) visit on 22-SEP-2007. The patient had a past medical history of idiopathic thrombocytopenia purpura (ITP). The patient presented with complaint of one day history of fever, sore throat and right-sided neck pain. She was diagnosed with viral pharyngitis, right cervical adenopathy most likely due to viral etiology. The patient had an office visit on 26-SEP-2007, with complaint of fever and sore throat, stiff back and shoulders for 4 days, tiredness, decreased appetite, no neck pain. The patient underwent a throat culture which result was negative. The patient had an office visit on 08-JUN-2007: the patient had an immunization visit and received GARDASIL, MENACTRA and VARIVAX (Merck). Assessment: viral infection, pharyngitis. On 20-MAY-2009, ICD-9 codes were received: Infection and inflammatory reaction due to other internal prosthetic device/implant/graft; Unspecified delay in development; Surgical operation, anastomosis/bypass/graft, with abnormal reaction/later complication, no surgical misadventure; Personal history of venous thrombosis and embolism; Primary hypercoagulable state; Personal history of venous thrombosis and embolism; Convulsions; Late effects of intracranial abscess/pyogenic infection; Encephalopathy; Late effects of viral encephalitis; Dehydration; Developmental coordination disorder; Developmental speech disorder. 20-MAY-2009 emergency department (ED) and hospital records were received, date of service (DOS) from 22-SEP-2007 to 12-APR-2009. FINAL DIAGNOSIS: Seizure disorder post vaccination: the patient initially presented to ED with one day history of fever, sore throat and right-sided neck pain, then repeated ED visits due to seizures, slurred speech, motor delay, tachycardia, skin graft anterior right foot, followed by cellulitis, repeated febrile illness with photophobia, hit her head several times, disconjugate gaze, facial twitching, temporal lobectomy, choreoathetoid movements of head, venous thrombosis and embolism left lower extremity, intracranial. The patient was treated with KEPPRA, DILANTIN, Phenobarbital, ATIVAN, PREVACID, DIASTAT, LOVENOX, IV antibiotics. During hospitalization, complete workup and labs were performed for spinal infections disease, genetic history etc. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Based upon the evaluation, it was concluded that there was no product impact on Fill 0658488 as a result of the filter integrity test deviations. The listing indicated that more of the events required hospitalization, was considered to be disabling, was considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 346229. No further information is available.