Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Full blood count normal, Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Laboratory test normal
Clinical narrative: Initial report received on 22/Sep/2006. A 16-year-old female patient had received an intramuscular, first dose injection of Menactra, lot number reported as 42107AA (not a valid manufacturer lot number), and intramuscular, first dose injection of Gardasil, lot number 0697F, on 31/Jul/2006. On or around 13/Aug/2006 or 14/Aug/2006, the patient experienced numbness and tingling in her feet and hands. The symptoms persisted and had slightly worsened at the time of her examination by a physician on 21/Aug/2006. At that time, neurological examination was normal. She had an elevated sedimentation rate (39), mild proteinuria, and otherwise normal labs. Other laboratory tests performed, (specific results not provided), included a blood count, blood chemistries, pregnancy test and drug screen. MRI was performed of the brain, cervical, thoracic and lumbosacral spine. MRI of the lumbosacral spine showed a (possibly old, chronic) subarachoid cyst. The patient was referred to and examined by a neurologist on 25/Aug/2006. During that exam, she was found to have weakened severely. She was admitted to a pediatric intensive care unit for suspected Guillain Barre syndrome which was confirmed by lumbar puncture. Lumbar puncture results were not provided. She was treated with IVIG with rapid improvement, and after five days of hospitalization, was discharged to home. Per the reporter, she is slowly improving and has residual weakness. Recovery status was documented as unknown. This case was confirmed as being Guillain Barre syndrome following Menactra vaccination. Follow-up information received on 27/Sep/2006. Per the reporter, the patient was hospitalized on 25/Aug/2006. The date of discharge was not reported. The patient's Guillain Barre syndrome was confirmed by lumbar puncture testing. Literature citation, update: Guillain Barre syndrome among recipients of Menactra Meningococcal conjugate vaccine June 2005-September 2006. Follow-up information received on 19 October 2006 from a health care professional concerning a publication. It was reported that the patient had experienced decreased strength in her lower extremities and absent deep tendon reflexes bilaterally in her upper and lower extremities. There were no diarrheal prodromes reported. Nerve conduction studies were consistent with Guillain Barre syndrome. Cerebrospinal fluid showed 0 WBC per UL and Protein 59 mg per dl. As of 07 September 2006, the patient still had residual weakness but was continuing to improve. Follow-up information received on 13 November 2006. The patient was back to school for one month. She was discharged from physical therapy since her legs were fine, but she is still in occupational therapy since her arms are still weak. Other than weak arms, she is back to normal. Follow-up information received on 15 November 2006 from another manufacturer, report number WAES0611USA01724. This report captured information from the same article that was previously reviewed for this case. No relevant additional information was provided for the adverse event. This follow up report is not submitted as a 15-day followup report. Follow-up information received on 12 February 2007 from another manufacturer, reference number WAES0702USA00913. The previously reported reference number reported by this manufacturer was WAES 0611USA01724. No relevant additional information was provided for the adverse event. This followup report is not submitted as a 15-day followup report. Follow-up information received on 28 February 2007 from another manufacturer, report number WEAS0611SUA01724. It was reported that the patient had been well on the day of immunization. Menactra and Gardasil were administered intramuscularly in the gluteus maximus. Diagnostic test included drug screen (normal), pregnancy test, blood count (normal), blood chemistries (normal). Gardasil lot number was provided as 653650/0697F. Per the report, "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 and was released. The reporter considered the events to e immediately life-threatening. This is a consolidation of two reports WAES#0611USA01724 and 0702USA00913." The patient was admitted to the hospital on 25 August 2006 and discharged on 05 September 2006. The patient's recovery status was reported as unknown. 02/01/2010 Still has slowly resolving weakness from Guillian Barre, but much improved.