Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, HPV4, MNQ, VARCEL
Symptoms: Epstein-Barr virus test positive, Facial palsy, Facial paresis, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Initial information received from the Centers for Disease Control and Prevention on 19 July 2007. An 18-year-old female patient received a dose of Menactra, lot number U2155CA, a dose of Varivax and a dose of Human Papilloma Virus Vaccine on 21 June 2007. The lot numbers were not reported for Varivax or Human Papilloma Virus Vaccine. 11 days after receiving the vaccines, the patient was diagnosed with Guillain-Barre syndrome. it was not reported what specific symptoms the patient experienced or whether she was hospitalized. No results of laboratory testing were provided. The patient's recovery status in unknown at the time of this report. This case is being followed by the Clinical Immunization Safety Assessment Network (CISA). Follow-up information received on 30 August 2007 from the Centers for Disease Control and Prevention. This case was confirmed by the Clinical Immunization Safety Assessment Network (CISA) as Guillain Barre Syndrome. No additional information was provided. Follow-up information received on 01 October 2007 from the Centers for Disease Control and Prevention. It was reported that the patient recovered. The date of recovery was not provided. This is in follow-up to report(s) previously submitted on 8/14/2007; 10/8/2007. Initial and follow up Information has been received from a physician and identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act, an 18 year old female with mild environmental allergies and positive Epstein-Barr Virus titer by history, with no pre-existing illness, who on 21-JUN-2007 was vaccinated IM in to right deltoid with a first dose of dose of GARDASIL lot #65786/0523U and concomitantly vaccinated, intramuscularly with VARIVAX (Merck) (lot # 657412/0594U) and MENACTRA, (lot # U2155CA), Sanofi Pasteur). The physician reported that the patient developed "GUILLAIN BARRE Syndrome" after receiving a dose of GARDASIL over at the hospital and had to be hospitalized. In follow up the physician reported that on 02-JUL-2007 the patient's parents contacted him and stated that the patient had foot and lip numbness. The patient went to the Emergency Room (ER) on 05-JUL-2007. She was admitted to the hospital on 05-JUL-2007 where she was seen by a neurologist and the neurologist diagnosed the patient with GUILLAIN-BARRE Syndrome. While hospitalized the patient received the following treatment intravenous (IV) therapy hyperalimentation for nutrition and IV immunoglobulin. She also received physical, speech and recreational therapy. She was discharged from the hospital on 27-JUL-2007. In the hospital unspecified labs and spinal tap were performed. The "spinal tap result was positive high protein and the culture was negative". The outcome was unknown. The listing indicated that one or more of the events required hospitalization. No further information is available. The reporter indicated that the patient's adverse events were disabling. Additional information has been requested. This is a consolidation of two reports concerning the same patient. It has been determined that WAES # 0708USA02055 is a duplicate of WAES # 0707USA04132. Therefore, WAES # 0708USA02055 is being deleted from our files on GARDASIL.