Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Immunoglobulin therapy, Impaired driving ability, Lumbar puncture, Malaise, Metabolic function test
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 concerning an 18-year-old female patient who on 17-JUN-2008 was vaccinated with a first dose of GARDASIL (lot # 660391/0063X) via intramuscular route into her right arm. Concomitant vaccination included the first dose of MENACTRA (lot # U2571AA) via intramuscular route into her right arm. On 11-AUG-2008, the patient experienced intolerable head/muscle pain, and muscle weakness "all over" arms. She also had "legs difficulty walking" and nausea. 911 was called and the patient was sent to emergency room for CT scan and was hospitalized. Her CT scan result was normal. Bloodwork and West Nile virus antibody test were performed with normal results according to her mother. On an unknown date, the patient was back to home with diagnosis of "possible viral infection". On 21-AUG-2008 the patient was weakness at doctor visit. She had a headache scaled 7; her not feeling well continued. The patient was sent to a neurologist emergency room for MRI scan and spinal tap. The patient also had electroencephalogram (EEG) on an unknown date. Results of MRI, spinal tap and EEG were not reported. Guillain-Barre Syndrome was diagnosed. On 26-AUG-2008, the patient was improving. The events required ER visit and hospitalization were considered to be serious. The original reporting source was not provided. The VAERS ID # is 323863. Additional information was obtained on request by the Company from the FDA under the Freedom of Information Act. Initial information has been received from a Registered Nurse (R.N.) concerning the female patient (also reported as 19 year old) who on 17-JUN-2008 was vaccinated with the first 0.5 ml dose of GARDASIL on 17-JUN-2008 (lot# 660391/0063X) along with concomitant vaccine of MENACTRA. On 11-AUG-2008 the patient experienced fatigue and walking problem. The patient was hospitalized from 21-AUG-2008 to 24-AUG-2008 and on 24-AUG-2008 the patient was diagnosed with Guillain Barre syndrome. At the time of reporting the patient was not recovered. Follow up information was received from a Registered Nurse (R.N.) on 06-MAY-2009 via telephone provided the patient's name and date of birth. She confirmed that the patient received the first and only dose of GARDASIL on 17-JUN-2008 (lot# 660391/0063X) along with concomitant vaccine of MENACTRA. The AE onset date was 11-AUG-2008 around 1:00 am. She went to the emergency room via ambulance with intolerable head and muscle pain, difficulty walking, nausea, and change of responsiveness. At the emergency room she was told that it was "viral " and was sent home. On 21-AUG-2008 she had a follow up doctor visit and she went into another hospital, while there she was referred to a neurologist. A CAT scan (negative results), EEG, Spinal Tap, MRI, and ultrasound of her bladder were performed. She was diagnosed with Guillain Barre syndrome. She was hospitalized from 21-AUG-2008 to 24-AUG-2008. She received immunoglobulin intravenously, pain medication, and physical therapy. Prior to this the patient had a baby. It was reported that as of 17-MAR-2009 the patient was still recovering and still going to physical therapy. Follow up information was received from medical records and the physician. The physician reported that the patient's GARDASIL was given by another provider. Medical records indicated that on 11-AUG-2009, the patient was seen by a physician, who reported in the history and physical that the patient, a right handed female who approximately ten days ago (approximately 01-AUG-2008), had a severe headache, was seen  in the emergency room. A computed axial tomography (CT) of the head and laboratory were unremarkable except for some sinusitis of the sphenoid. The patient went to see ear, nose and throat (ENT) specialist and was started on LEVAQUIN. She then subsequently started to notice some numbness in her toes which then progressed up past the ankles and then into the hands and she noticed that her feet were weak and she had trouble holding her flute up. The physician reported that the patient said that her sensation was sort of absent or abnormal from just above the umbilicus. She denied bowel or bladder difficulties. She continued to have headache at about an 8 out of 10 and in the occiput. She denied any previous illness of nausea, vomiting, viral symptoms or fever and chills. The patient reported a past medical history of having a baby 9 1/2 months ago and she has had knee arthroscopic surgery bilaterally. Her only medication was the LEVAQUIN at 500 mg a day. Review of the systems by the physicians showed for musculoskeletal, that the patient had some problems with her knees, and she denied any other injuries. She had no tic bites, no mosquito bites that she was aware of. Physical exam showed a blood pressure of 102/70, pulse 70, respirations 16, and temperature of 99.1 axillary. She had complaints of a severe headache but she was able to converse and smile and had no pain expression. Motor examination showed absent reflexes at the elbow and brachial radialis was trace. She was able to arise from the bed unaided, and walk without assistance. Sensation showed level of about T6-T7 to vibratory, temperature and sharp/dull. Umbilical reflexes are diminished and abdominal reflexes are diminished. The physician's impression was that the history was concerning for Guillain-Barre, however the exam showed still relatively brisk reflexes in the lower extremities which would with the combined T6-7 level make it more suspicious for a space occupied lesion versus a possible transverse myelitis. Plan was for MRI of the spine and if they were unremarkable to proceed with a spinal tap. The physician noted that the patient was clearly within the first two weeks of the illness and therefore it was difficult to diagnose Guillain-Barre due to the early presentation. She would be followed closely and assess her respiratory status. She would be admitted for at least 24 hours observation, MRI's and lumbar puncture and care would be determined at that time. The patient's discharge summary indicated that she was admitted on 21-AUG-2008, and underwent MRI of the brain indicated for numbness, which was unremarkable, except for a right temporal arachnoid cyst. MRI of the cervical-spine was unremarkable, and MRI of the thoracic spine showed a small disc cyst at T6-T7. She also on 21-AUG-2008, underwent a chest x-ray indicated for headaches, the impression was negative chest. Laboratory included complete blood count (CBC), and complete metabolic panel (CMP) which was normal. On 21-AUG-2008, quantitative immunoglobulin showed adequate amounts of IgA, IgM, and IgG. On 22-AUG-2008, she was evaluated for suspect Guillain Barre, and had a motor nerve conduction study for which the impression was that it was a normal study. The patient was monitored, and she had progressive worsening of her paresthesias up to the elbow, so it was determined to proceed with intravenous immunoglobulin (IVIG). The patient tolerated the IVIG well without any side effects. Her headache resolved, and on the day of discharge, her paresthesias had resolved, except for in her feet. Her strength was improving, therefore she was discharged home with her fourth and final IVIG treatment to be performed on an outpatient basis. She would complete her LEVAQUIN course for the sinusitis and otherwise had no new medications. On 24-AUG-2008, the patient was discharged. She was to follow up with the physician on Friday morning, she was not to drive, and she could return to class on Wednesday. Her discharge diagnosis was Guillain-Barre. On 28-AUG-2008, cerebrospinal study (CSF) showed 0 white cells, protein was 13, and glucose was 57. CSF had negative gram-stain and negative cultures. West Nile virus and Lyme titer test were pending. The physician reported that the patient recovered from Guillain Barre on 29-AUG-2008. Additional information is not expected. This is a consolidation of two reports concerning the same patient. It has been determined that WAES # 0905USA00591 is a duplicate of WAES #0809USA02812. Therefore, WAES # 0905USA00591 is being deleted from our files and the reports consolidated into WAES #0809USA02812.