Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Ophthalmological examination abnormal, Optic neuritis, Visual acuity reduced, Visual acuity tests abnormal, Visual evoked potentials normal
Clinical narrative: Sudden onset of severe (L) eye pain. dx: optic neuritis 12/10/07-records received for DOS 6/15-11/26/07-DX: Optic neuritis. C/O painful eye movements OS starting 3 days after booster shot of Gardasil. Left eye lost centrl acuity and color vision. Two month later right eye became blurred and coloress. On exam 11/26/07 vision is 10/150 OU and no Marcus Gunn pupil defect. She saw 8 of 14 color plates and her D15 color testing was perfectly normal. Visual fields not real reliable with poor fixation but there was a suggestion of a right lower quadrantanopsia in both eyes (homonymous) and concentral defect OU. No optic pallor or temporal optic nerve fiber thinning after true optic neuritis on the OCT and there was none. Acute zonal retinopathy appears to be improving. AMPPE could be post viral. Per 60 day follow up: About 60% improved visual acuity has improved 20/150 to 20/50 OU; color ision has improved to 19/19 OU. This is in follow-up to report(s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a physician concerning a 12 year old female patient with seasonal allergies, environmental allergies, an allergy to ciprofloxacin and a history of pyelonephritis, inflammation conditions, and a tonsillectomy, who on 04-JUN-2007 vaccinated intramuscularly with a 0.5mL first dose of GARDASIL (lot# 657236/0389U). Concomitant therapy included ZYRTEC. On 08-AUG-2007 the patient received her second dose of GARDASIL (lot# 658488/0930U) in the right arm. On 11-AUG-2007 the patient experienced optic neuritis/trochleitis and severe eye pain when looking to the left (also reported as left eye pain). It was reported that the patient's colors were "muddy." The patient was seen by a optometrist, an ophthalmologist, and then referred to a neuro ophthalmologist. Laboratory diagnostics were performed (results located in laboratory section). On 12-SEP-2007 the patient presented with possible retrobulbar optic neuritis in the left eye. The patient was having moderate to sever pain and a mild blur in the left eye since August. The symptoms were reported to be worse in the evening. The patient was treated with drops, which took some pain away but not all of it. The patient stated that she started having some pain in the right eye since 11-SEP-2007. The patient's visual acuity was reported to be "sc 20/25 jl" in the right eye, and "sc20/40 Jl" in the left eye. The patient's color vision was 7/7 in the right eye and 6/7 in the left eye. The patient was diagnosed with decreased vision in the left eye, exophoria, and hyperopia. On 24-SEP-2007 the patient's visual field testing was within normal limits on the right, except for a few nonspecific changes and a foveal sensation of 32dB. On the left, there was diffuse nonspecific loss and also foveal sensation of 30dB. The patient's slit lamp pupils, sensorimotor, external, and funduscopic evaluations were reported to be essentially unremarkable. There was no afferent pupillary defect. The patient did have point tenderness over the left trochlea consistent with left trochleitis. The physician believed that the visual field loss and visual loss were functional. The patient was treated with DOLOBID. On 16-OCT-2007 the patient had a pattern reversal visual evoked response test performed with normal response in each eye. On 26-OCT-2007 AN MRI of the brain and the orbits were performed and both were normal. The outcome for the events of exophoria, hyperopia, mild blurred vision, decreased vision in left eye, colors muddy/dim vision, and right eye pain were not reported. On an unspecified date, the patient recovered from optic neuritis/trochleitis and eye pain. Additional information is not expected.