Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Paraesthesia, Red blood cell count increased, Urine analysis abnormal, White blood cell count abnormal
Clinical narrative: It was reported in a published literature article title as stated above through MMWR on a review of reports, submitted to VAERS that a 16 year old (also reported as 17 year old) female was vaccinated IM into the gluteus maxima on 31-JUL-2006 with a dose of Gardasil (lot # 653650/0697F) and a dose of Menactra (lot # 42107AA) IM in the gluteus maximus. On 13-AUG-2006, she experienced numbness and tingling in her extremities. On 25-AUG-2006, she was evaluated by a neurologist for increasing weakness and subsequently admitted to the hospital. On physical examination, she was found to have absence reflexes bilaterally in the upper and lower extremities and had decreased muscle strength in the lower extremities. Nerve conduction studies were consistent for Guillain-Barre syndrome. An analysis of the cerebrospinal fluid showed the protein to be 59 mg/dL with no white blood cells. The patient received IV immunoglobulin improved and was discharged on 05-SEP-2006. As of 07-SEP-2006, the patient still had residual weakness but was continuing to improve. The article also discussed the experience of a 43 year old male while on therapy with MMR (manufacturer unknown) (WAES# 0611USA01723) and a 15 year old female on therapy with hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) (WAES#0611USA00989). This is a an amended report. The statement "through MMWR on a review of reports, submitted to VAERS" has been added to the narrative and the primary and initial source type was changed from physician to agency. Additional information was received from VAERS agency. On 13 or 14-AUG-2006, thirteen days after the vaccination, the patient began having numbness and tingling in her feet and hands which persisted and slightly worsened until she was seen in our office on 21-AUG-2006. Her neurological examination was normal. She had an elevated sedimentation rate (39), mild proteinuria (albuminuria), otherwise normal labs. Magnetic resonance imaging (MRI) of her lumbosacral spine showed a (possibly old, chronic) subarachnoid cyst. She was referred to a neurologist and was seen on 25-AUG-2006 and was found to have weakened severely and was admitted to the PICU for suspected Guillain Barre syndrome which was confirmed by a lumbar puncture. She was well on the day of immunization but later said she was weak and several months this was not objectively noticed then, but shortly after the vaccine. On an unspecified date, the patient was hospitalized. Other diagnostic tests performed included MRI of brain, cervical, thoracic spine, drug screen, pregnancy test, blood count, blood chemistries and lumbar puncture. Results of the tests were not specifically provided. Outcome was reported as unknown. Follow up information received from a company representative regarding an article indicated that on 13-AUG-2006 the patient had increased numbness and tingling in her feet and hands and was subsequently evaluated by a neurologist and was diagnosed with Guillain Barre syndrome. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Standards of the Center for Biologics Evaluation and Research and was released. The reporter considered the events to be immediately life-threatening. This is a consolidation of two reports WAES # 0611USA01724 and 0702USA00913. No further information is available. This report was filed with the FDA. The VAERS number is 262735.