Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Recurrent acute ophthalmoparesis syndrome; Recurrent COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of OPHTHALMOPLEGIA (Recurrent acute ophthalmoparesis syndrome) in a 48-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OPHTHALMOPLEGIA (Recurrent acute ophthalmoparesis syndrome) (seriousness criterion medically significant) and COVID-19 (Recurrent COVID-19). The patient was treated with Immunoglobulins nos (Immunoglobulin i.v) at a dose of 2 gram per kilogram. At the time of the report, OPHTHALMOPLEGIA (Recurrent acute ophthalmoparesis syndrome) and COVID-19 (Recurrent COVID-19) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti-aquaporin-4 antibody: (Negative) at Initial presentation. On an unknown date, Anti-ganglioside antibody: (Negative) anti-GQ1b IgG at Initial presentation and (Negative) anti-GQ1b IgG at Recurrence. On an unknown date, Antinuclear antibody: (Negative) Anti-MOG IgG at Initial presentation and (Negative) Initial presentation. On an unknown date, C-reactive protein (0-5): less than 3 at Initial presentation. On an unknown date, CSF cell count (0-5): Cerebrospinal fluid Nucleated cells 0. On an unknown date, CSF glucose (40-70): 57. On an unknown date, CSF immunoglobulin (0-0.7): 0.4. On an unknown date, CSF protein (0-44): 36. On an unknown date, CSF red blood cell count: 0. On an unknown date, CSF test: normal. On an unknown date, HIV antibody: (Negative) at Initial presentation. On an unknown date, Magnetic resonance imaging: revealed T2 hyperintensity, enlargement, and enhancement of left CN III extending from the cavernous sinus into the posterior orbit., after vaccination showed similar T2 signal abnormality and enhancement of left CN III and Repeated approximately 7 months after hospitalization showed persistent enlargement and T2 hyperintensity of the left CN III with resolution of prior abnormal enhancement. On an unknown date, Neuro-ophthalmological test: At the time of the initial presentation, pupils were equally round and reactive to light. There was trace ptosis of the left upper eyelid. Horizontal ductions were full. There was a -2 supraduction deficit in both eyes that was partially overcome with head thrusts downward. There was a -1 infraduction deficit in the left eye. There was no nystagmus. There was no fatiguability of ductions. The findings were felt to suggest a partial supranuclear upgaze palsy and partial left third cranial nerve palsy. and At the time of recurrence, pupils were equally round and reactive to light. There was no ptosis. There was a trace adduction deficit of the left eye, with horizontal ductions otherwise full. There was a -1 supraduction deficit in the right eye and -2 supraduction deficit in the left eye, both of which were partially overcome with head thrusts downward. There was a -1 infraduction deficit in the left eye. There was no nystagmus. There was no fatiguability of ductions. The findings were felt to suggest a partial supranuclear upgaze palsy and partial left third cranial nerve palsy.. On an unknown date, Neurological examination: normal, a partial supranuclear vertical gaze palsy and a partial left cranial nerve (CN) III palsy and after vaccinations showed partial supranuclear vertical gaze palsy and partial left CN III palsy. On an unknown date, Oligoclonal band assay (0-3): 0. On an unknown date, Polymerase chain reaction: (Negative) Cerebrospinal fluid Meningitis/encephalitis PCR panel. On an unknown date, Red blood cell sedimentation rate (0-32): 5 at Initial presentation. On an unknown date, SARS-CoV-2 antibody test: (Negative) at Initial presentation and (Negative) at Initial presentation. On an unknown date, SARS-CoV-2 test: Negative and (Positive) by nasopharyngeal swab. On an unknown date, Treponema test: (Negative) at Initial presentation. On an unknown date, Viral test: (Negative) severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2) PCR in the CSF. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. Patient with no significant medical history presented with vertical diplopia and 3 days of upper respiratory symptoms. She tested positive for SARS-CoV-2 by nasopharyngeal swab. Examination revealed a partial supranuclear vertical gaze palsy and a partial left cranial nerve (CN) III palsy. The remainder of her neurologic examination was normal. Laboratory results included normal CSF profile, negative severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2) PCR in the CSF, and negative serum anti-GQ1b IgG. MRI revealed T2 hyperintensity, enlargement, and enhancement of left CN III (Fig. 1). She was treated with intravenous immune globulin and her diplopia rapidly improved. Six weeks later, her neuro-ophthalmologic examination was normal, and her symptoms had resolved. She subsequently received 2 doses of the Moderna mRNA COVID-19 vaccine without complication. She subsequently received 2 doses of the Moderna mRNA COVID-19 vaccine without complication. Twenty-six months later, she presented with 4 days of nasal congestion and 2 days of diplopia. She tested positive for SARS-CoV-2 by nasal swab. Her neurologic examination again showed partial supranuclear vertical gaze palsy and partial left CN III palsy. Serum anti-GQ1b IgG was negative. She was treated with IVIG and her diplopia rapidly improved. At follow-up 6 weeks later, her examination was normal, and she was asymptomatic. Author stated that to their knowledge, this may be the 1st reported case of recurrent AO associated with recurrent COVID-19. Although patient did not have the typical clinical triad of MFS, author classified her as having AO variant MFS based on the para-infectious onset, combined central and peripheral oculomotor dysfunction, imaging findings, and response to immunotherapy.; Reporter's Comments: Company comment: Event of ophthalmoplegia is assessed as not related to Spikevax NOS considering that COVID 19 reinfection could provide more likely etiology. The benefit-risk relationship of product is not affected by this report.
Test Name: Serum Anti-AQP4 IgG; Test Result: Negative ; Test Name: serum anti-GQ1b IgG; Test Result: Negative ; Test Name: serum anti-GQ1b IgG; Test Result: Negative ; Test Name: Serum Anti-MOG IgG; Test Result: Negative ; Test Name: Serum Antinuclear antibody pane; Test Result: Negative ; Test Name: Serum C-reactive protein; Result Unstructured Data: less than 3 at Initial presentation; Test Name: Cerebrospinal fluid Nucleated cells; Result Unstructured Data: Cerebrospinal fluid Nucleated cells 0; Test Name: Cerebrospinal fluid Glucose; Result Unstructured Data: 57; Test Name: Cerebrospinal fluid IgG index; Result Unstructured Data: 0.4; Test Name: Cerebrospinal fluid Protein; Result Unstructured Data: 36; Test Name: Cerebrospinal fluid Red blood cells; Result Unstructured Data: 0; Test Name: CSF profile; Result Unstructured Data: normal; Test Name: Serum HIV antibody/antigen; Test Result: Negative ; Test Name: MRI; Result Unstructured Data: revealed T2 hyperintensity, enlargement, and enhancement of left CN III extending from the cavernous sinus into the posterior orbit.; Test Name: MRI; Result Unstructured Data: after vaccination showed similar T2 signal abnormality and enhancement of left CN III; Test Name: MRI; Result Unstructured Data: Repeated approximately 7 months after hospitalization showed persistent enlargement and T2 hyperintensity of the left CN III with resolution of prior abnormal enhancement; Test Name: neurologic examination; Result Unstructured Data: normal; Test Name: neurologic examination; Result Unstructured Data: a partial supranuclear vertical gaze palsy and a partial left cranial nerve (CN) III palsy; Test Name: neurologic examination; Result Unstructured Data: after vaccinations showed partial supranuclear vertical gaze palsy and partial left CN III palsy; Test Name: neuro-ophthalmologic examination; Result Unstructured Data: At the time of the initial presentation, pupils were equally round and reactive to light. There was trace ptosis of the left upper eyelid. Horizontal ductions were full. There was a -2 supraduction deficit in both eyes that was partially overcome with head thrusts downward. There was a -1 infraduction deficit in the left eye. There was no nystagmus. There was no fatiguability of ductions. The findings were felt to suggest a partial supranuclear upgaze palsy and partial left third cranial nerve palsy.; Test Name: neuro-ophthalmologic examination; Result Unstructured Data: At the time of recurrence, pupils were equally round and reactive to light. There was no ptosis. There was a trace adduction deficit of the left eye, with horizontal ductions otherwise full. There was a -1 supraduction deficit in the right eye and -2 supraduction deficit in the left eye, both of which were partially overcome with head thrusts downward. There was a -1 infraduction deficit in the left eye. There was no nystagmus. There was no fatiguability of ductions. The findings were felt to suggest a partial supranuclear upgaze palsy and partial left third cranial nerve palsy.; Test Name: Cerebrospinal fluid Oligoclonal bands; Result Unstructured Data: 0; Test Name: Cerebrospinal fluid Meningitis/encephalitis PCR panel; Test Result: Negative ; Test Name: Serum Erythrocyte sedimentation rate; Result Unstructured Data: 5 at Initial presentation; Test Name: Serum SARS-CoV-2 IgG; Test Result: Negative ; Test Name: Serum SARS-CoV-2 IgM; Test Result: Negative ; Test Name: Cerebrospinal fluid SARS-CoV-2 PCR; Test Result: Negative ; Test Name: SARS-CoV-2 infection test; Test Result: Positive ; Test Name: Serum Rapid plasma reagin; Test Result: Negative ; Test Name: severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2) PCR in the CSF; Test Result: Negative