Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Optic neuropathy, Pain in extremity, Rash
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. On 15-MAR-2007, a 13 year old female patient with eczema and a history of constipation and Raynaud's phenomenon and no pre vaccination illness was vaccinated with the first dose of GARDASIL. On 07-MAY-2007 the patient was vaccinated with the second dose of GARDASIL. On 14-SEP-2007, the patient received the third dose of GARDASIL. The patient experienced rashes after three vaccinations separately on 20-MAR-2007, 26-MAY-2007, 24-SEP-2007 and 27-NOV-2007. In February 2008 while on vacation the patient developed pain and decreased vision in left eye. MRI demonstrated enhancing lesion in left optic nerve, neuraxis. It was diagnosed as neuromyelitis optica (NMO). Three weeks ago the patient also had intermittent episodes low back pain and hospitalized for severe impaction. On 20-FEB-2008, the patient experienced left optic neuropathy and was treated with prednisone. Test was positive for NMO IgG. On 28-FEB-2008, MRI brain scan was performed to determine damage to optic nerve. On 27-MAR-2008, the diagnosis of NMO from clinic was known. Treatment with ritiximab was discussed. On 10-APR-2008, MRI thoracic spine was performed and discovered lesion. On 14-APR-2008 chest X-ray was performed (not result provided). On 16-MAY-2008, the patient experienced leg pain and numbness. On 20-MAY-2008 hospital visit confirmed diagnosis of NMO. On 15-JUN-2008 to 17-JUN-2008, the patient experienced back pain, numbness in right leg and stomach numbness. On 18-JUN-2008 MRI was performed and thoracic spinal lesion was confirmed. Infusion SOLU-MEDROL 1000 mg was taken. On 22-JUN-2008 the patient had back pain, numbness right leg and stomach numbness again. MEDROL tablet was started. On 14-JUL-2008 MRI thoracic follow up was performed (no result provided). On 20-AUG-2008 the patient experienced back pain. MRI was performed and the result noted thoracic lesion. On 06-OCT-2008, 07-OCT-2008 and 27-OCT-2008 the patient had back pain again. On 24-NOV-2008 records was received that in December 2006, the patient experienced 3-5 episodes nausea, vomiting and abdominal pain (onset conflicts with start date of vaccination), and on 12-JAN-2007 symptoms resolved. The medical team's initial evaluated that GARDASIL was the "trigger" that caused the NMO to surface. At the time of the report, the patient had recurrence of back pain and numbness below waist, and numbness in both lower extremities in left was greater than right. The patient required ER visit. The listing indicated that one or more of the events required hospitalization, and was considered to be disabling and immediately life-threatening. No further information is available. Subsequently, the patient's experience was reported in a published article. There was ongoing debate regarding the association of certain vaccinations with the development of central nervous system (CNS) demyelination. The authors conclude that GARDASIL might be associated with central nervous system demyelination, although they admitted that there was not enough information to prove causality. This was originally reported by a healthcare professional. The VAERS ID# is 332160. Additional information is not expected. It was determined that the country of the primary source of WAES#0901USA01085 was incorrectly reported. Therefore this report, WAES #1006USA03377, was created with the correct source country to replace WAES #0901USA01085 which is being deleted from our files for V-501. It has been determined that the country of the primary source of WAES # 0901USA01085 was incorrect. Therefore, WAES # 0901USA01085 is being deleted from our files for V501 and WAES # 1006USA03377 was created with the correct country to replace this report. WAES #0901USA01085 was previously submitted to the FDA on 16-JUN-2010.