Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Electromyogram, Immunology test, Lumbar puncture, Magnetic resonance imaging head
Clinical narrative: Miller Fisher syndrome; Mydriasis; This literature-non-study case was reported in a literature article and describes the occurrence of MILLER FISHER SYNDROME (Miller Fisher syndrome) and MYDRIASIS (Mydriasis) in a 62-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.   The patient's past medical history included Toxic encephalopathy (idiopathic toxic encephalopathy and required intubation.) in 1992, Diarrhea (diarrheal illness) in 2000 and Mydriasis (In 1992 and 2000 and had complete recovery in both episodes.) in 1992. Previously administered products included for Product used for unknown indication: intravenous immunoglobulin in 2000. Past adverse reactions to the above products included No adverse event with intravenous immunoglobulin.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MILLER FISHER SYNDROME (Miller Fisher syndrome) (seriousness criteria hospitalization and medically significant) and MYDRIASIS (Mydriasis) (seriousness criterion hospitalization). The patient was treated with IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) (intravenous use) at a dose of .4 gram per kilogram once a day. At the time of the report, MILLER FISHER SYNDROME (Miller Fisher syndrome) had resolved and MYDRIASIS (Mydriasis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: (Positive) anti-GQ1b antibodies was positive confirming the diagnosis of MFS.. On an unknown date, Electromyogram: normal. On an unknown date, Immunology test: normal. On an unknown date, Lumbar puncture: Lumbar puncture revealed elevated protein of 79.. On an unknown date, Magnetic resonance imaging head: chronic microvascular ischemic changes and orbital imaging was unremarkable.. On an unknown date, Neurological examination: normal bulk and tone with 5/5 strength throughout and mildly reduced vibratory sense distally with intact sensation to light touch, pinprick, and temperature.. On an unknown date, Ophthalmological examination: Both pupils were dilated to 6 mm and unresponsive to light or near stimuli. Ocular motility showed limitation in all gaze directions bilaterally, and his right worse than left lid ptosis. Anterior segment and dilated fundus  examination were unremarkable.. On an unknown date, Reflex test: Reflexes were markedly diminished, 1+ in the upper and absent in the lower extremities.. On an unknown date, Visual acuity tests: 20/20 -2 bilaterally.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered MILLER FISHER SYNDROME (Miller Fisher syndrome) to be related. No further causality assessment was provided for MYDRIASIS (Mydriasis).   Company comment: This literature-non-study case concerns a 62-year-old male patient, with no recent trauma, travel or infection, and 2 previous episodes of diplopia and enlarged pupils followed by stupor, intubation, and prolonged hospitalization. Records were limited but referenced an idiopathic toxic encephalopathy in 1992 and after a diarrheal illness in 2000. The patient experienced the unexpected and serious (due to hospitalization and medically significant) AESI of Miller Fisher syndrome, and the unexpected and serious (due to hospitalization) event of Mydriasis, which occurred 1 day after SPIKEVAX NOS vaccine, administered as booster dose within COVID-19 vaccination schedule. As reported, the patient presented with binocular horizontal diplopia with difficulty with near reading and painless blurry vision bilaterally for 1 week. Associated symptoms included dizziness, unsteady gait, and bilateral upper and lower extremity weakness and numbness. He denied having respiratory symptoms, dysphonia, or dysphagia. Visual acuity was 20/20 -2 bilaterally. Both pupils were dilated to 6 mm and unresponsive to light or near stimuli. Ocular motility showed limitation in all gaze directions bilaterally, and his right worse than left lid ptosis. Anterior segment and dilated fundus examination were unremarkable. Neurological examination demonstrated normal bulk and tone with 5/5 strength throughout and mildly reduced vibratory sense distally with intact sensation to light touch, pinprick, and temperature. Reflexes were markedly diminished, 1+ in the upper and absent in the lower extremities. There was dysmetria with finger extension to nose and truncal ataxia, requiring constant support to sit upright. MRI of the brain showed chronic microvascular ischemic changes and orbital imaging was unremarkable. Lumbar puncture revealed elevated protein of 79. Autoimmune workup and electromyography testing were normal. The decision was made to start 0.4 g/kg per day of intravenous immunoglobulins for 5 days due to concern for recurrent Miller Fisher syndrome (MFS). On treatment, his diplopia, ptosis, and ophthalmoplegia improved, and he was discharged to an acute rehab unit for recovery. During 6-month follow-up, the patient noted improved blurred vision with stable visual acuity. Pupils were briskly reactive, his ocular motility was full bilaterally, and his coordination improved. Laboratory results were positive for anti-GQ1b antibodies, confirming the diagnosis of MFS. Patient´s medical history could be a confounding factor for the case. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.  Concomitant medications were not reported.  Patient presented with binocular horizontal diplopia with difficulty with near reading and painless blurry vision bilaterally for 1 week. Associated symptoms included dizziness, unsteady gait, and bilateral upper and lower extremity weakness and numbness.  He reported 2 previous episodes of diplopia and enlarged pupils followed by stupor, intubation, and prolonged hospitalization. His third episode did not present with altered mentation, comatose state, or hyperreflexia, which is more consistent with MFS. In 1992 and 2000, he experienced ocular dysmotility and mydriasis but also had encephalopathy requiring intubation and had complete recovery in both episodes.  Patient reported dilated pupils during his episodes in 1992 and 2000. Pupil involvement with segmental palsy with vermiform movements and light-near dissociation may be more frequent than documented in MFS.  There was dysmetria with finger extension to nose and truncal ataxia, requiring constant support to sit upright.  After treatment diplopia, ptosis, and ophthalmoplegia improved, and he was discharged to an acute rehab unit for recovery.  During 6-month follow-up, the patient noted improved blurred vision with stable visual acuity. Pupils were briskly reactive, his ocular motility was full bilaterally, and his coordination improved.