Age: 1.4
Sex: M
Vaccine: FLU3
Symptoms: Neurological examination normal, Nuclear magnetic resonance imaging normal, Ophthalmological examination abnormal, Ophthalmoplegia, Strabismus
Clinical narrative: Initial report received on 17 March 2009 from a literature collection. " A previously healthy 17 month old boy was inoculated with FLUZONE SV '2005-'2006 USP (lot number U1804AA) by intramuscular injection. Three weeks later, when he was otherwise well and did not appear to be in pain, his mother noted that he was esotropic. There was no history of antecedent febrile illness, trauma, or family history of strabismus. Ophthalmic examination, revealed a 45 degree esotropia in primary gaze increasing to a 65 degree esotropia in right gaze and orthotropia in left gaze. Examination of ductions revealed marked limitation of abduction of the right eye and full ductions of the left eye, consistent with right lateral rectus paralysis. Cycloplegenic refraction revealed +1.5 D spherical error for each eye. The remainder of the ophthalmic examination, including dilated fundus examination, was normal. A complete neurological examination was unremarkable. Magnetic resonance imaging (MRI) was performed, including T1, T2 fluid attenuation inversion recovery (FLAIR), and fat saturation views of the brain and orbits. Gadolinium-enhanced imaging used 3 mm slices without interslice gap and non enhanced imaging used 1 mm slice resolution of the brain and orbits. Fast imaging used 1 mm slice resolution of the brain and orbits. Fast imaging using steady state acquisition sequencing was used to achieve submillimter resolution in assessing the course of the sixth nerve from the ventral medulla into the cavernous sinus and orbit. Neuroimaging did not reveal any abnormality. Part-time occlusion therapy of his left eye was instituted, and repeat examination at 4 months revealed a 15 degree esotropia in primary gaze with improved abduction of the right eye. Subsequent examinations revealed orthotropia in primary gaze and a 10 degree esotropia in right gaze with minimal limitation of abduction of the right eye at 6 months and orthotropia in all diagnostics positions of gaze at 9 months at which time occlusion therapy was discontinued. The child was then well until 1 year after the onset of symptoms when 3 weeks after receiving FLUZONE (lot number U2174GA), his esotropia recurred. He otherwise appeared well and did not appear to be in pain. He exhibited a 10 to 20 degree incomitant esotropia with limitation of abduction of the right eye. The patient was orthotropic in levoversion. The remainder of the ophthalmic examination was unremarkable. A neurological examination and MRI of the brain and orbits without gadolinium failed to reveal any abnormalities. Repeat examination at 6 weeks demonstrated orthotropia in primary and left gaze, and a 10 degree esotropia in right gaze. The residual motility deficit failed to resolve over the subsequent 7 months." 27 March 2009: A corrective version with the latest received date of the previous version, 17 March 2009, was created in order to add the second dose of FLUZONE to the case. The reporter of this case is the same as case number 2009-01134. List of Documents held by Sender: none.