Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Guillain-Barre syndrome, Hyperkinesia, Immunoglobulins, Laboratory test abnormal, Neutrophil count increased
Clinical narrative: Initial and follow-up information has been received from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning an approximately 16 year old female with attention deficit disorder who on 07-JUL-2006 was vaccinated intramuscularly with the first dose of Gardasil (lot # 653937/0637F). Concomitant vaccination included MENACTRA (batch# U2069AA). Other concomitant therapy included ADDERALL TABLETS and hormonal contraceptives (unspecified). There were no illnesses at the time of vaccination. On 20-JUL-2006, the patient experienced weakness (times several months), dehydration, gait abnormality, hyperkinesia, paresthesia, and psychomotor hyperactivity and was noted to have an abnormal lab test and was diagnosed with Guillain-Barre syndrome. The patient was subsequently hospitalized for one day. The patient subsequently recovered from the events after a duration of thirteen days. It was reported that the patient had been well on the day of vaccination, however, shortly after vaccination, she became weak, but several months later, her symptoms were not objectively noticed. It was reported that the symptoms may have been prior to vaccination. On 27-SEP-2007, it was reported that the onset of symptoms may have started in June 2006 prior to vaccination. The neurologist's history of weakness goes back to late June before immunization. The primary care physician based his report on a physician assistant's screening history prior to vaccine administration that was not specific for neurologic symptoms. On 28-SEP-2006, medical records from neurologists revealed that the patient was seen by her primary care physician on 31-JUL-2006 with complaints of loss of strength over the past 3 months. Labs were done which showed mild dehydration and elevated neutrophils. Eosinophils were absent. The patient was referred to a neurologist and the initial evaluation on 03-AUG-2006 revealed that the patient noted the weakness beginning in June which had progressively worsened. Symptoms including tingling sensation at the tip of the fingers and significant weakness to the point that she could not do her own hair. The patient's birth history was within normal limits and the only past medical history was ADD and the patient had been on ADDERALL for approximately 1 year as well as birth control pills. The exam showed definite weakness of all extremities, especially the upper extremities and neck. Reflexes were absent in the legs. Gait was normal but she had difficulty taking steps without support and could not rise from sitting without help. Normal CPK made diagnosis difficulty and EMG/NCS performed on 04-AUG-2006 was strongly positive for GBS. The patient was subsequently admitted to the hospital on 04-AUG-2006 and was treated with IVIG times 2 days and placed in a rehabilitation facility on 05-AUG-2006 for evaluation and physical therapy, then the patient received home physical therapy. The patient was seen by neurology again on 24-AUG-2006 which showed improvement but the patient still had weakness especially in the hands. The patient was now able to rise from sitting on the floor without support, however there was still no reflexes in the legs. Complete but slow recovery was expected at that time. The original reporting source was not reported. No further information is available.