Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Neurological examination, Physical examination, Pupillary light reflex tests
Clinical narrative: Isolated unilateral oculomotor nerve palsy; suspected post-vaccination autoimmune reaction; mild malaise; This literature-non-study case was reported in a literature article and describes the occurrence of IIIRD NERVE PARALYSIS (Isolated unilateral oculomotor nerve palsy) and AUTOIMMUNE DISORDER (suspected post-vaccination autoimmune reaction) in an 81-year-old male 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, the patient experienced IIIRD NERVE PARALYSIS (Isolated unilateral oculomotor nerve palsy) (seriousness criteria hospitalization and medically significant), AUTOIMMUNE DISORDER (suspected post-vaccination autoimmune reaction) (seriousness criteria hospitalization and medically significant) and MALAISE (mild malaise). At the time of the report, IIIRD NERVE PARALYSIS (Isolated unilateral oculomotor nerve palsy) and AUTOIMMUNE DISORDER (suspected post-vaccination autoimmune reaction) had resolved and MALAISE (mild malaise) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti-ganglioside antibody: (Positive) IgG/IgM 70 IV (0-50). On an unknown date, Computerised tomogram head: Negative. On an unknown date, Magnetic resonance imaging head: Negative. On an unknown date, Neurological examination: patient had a right ptosis and deficiencies in right eye adduction and vertical gaze. His pupils were both reactive to light. On an unknown date, Physical examination: the patient was pleasant, coherent, cooperative, and oriented. On an unknown date, Pupillary light reflex tests: On digital pupillometry, his pupils showed slightly different sizes (right: 3.22 mm, left: 3.45 mm) and demonstrated decreased reactivity in the right eye (Neurological Pupillary Index: right 2.2, left 2.7). These findings were consistent with an isolated right oculomotor nerve palsy that spared the pupil.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered IIIRD NERVE PARALYSIS (Isolated unilateral oculomotor nerve palsy), AUTOIMMUNE DISORDER (suspected post-vaccination autoimmune reaction) and MALAISE (mild malaise) to be related.   Company comment: This case received from regulatory authority concerns an 81-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of IIIrd nerve palsy (Isolated unilateral oculomotor nerve palsy) and autoimmune disorder (suspected post-vaccination autoimmune reaction) and non serious event of malaise. Event of malaise occurred on the day of vaccination while oculomotor nerve palsy symptoms started 14 days after receiving a booster dose of Spikevax NOS. As reported, patient presented to emergency department 16 days after a booster vaccination, with 2 day history of diplopia. Patient only had mild malaise on day of vaccination with no other symptoms. On examination patient had a right ptosis and deficiencies in right eye adduction and vertical gaze. His pupils were both reactive to light. On digital pupillometry, his pupils showed slightly different sizes (right: 3.22 mm, left: 3.45 mm) and demonstrated decreased reactivity in the right eye (Neurological Pupillary Index: right 2.2, left 2.7). These findings were consistent with an isolated right oculomotor nerve palsy that spared the pupil. Patient was hospitalized but condition started to improve after 3 days with no immunosuppressive treatment initiated and patient was discharged. Results of immunological examinations came back positive for Anti-ganglioside antibody: IgG/IgM 70 IV (0-50). Per authors the positive Asialo-GM1 antibody test suggests a possible post-vaccination autoimmune reaction. The benefit-risk relationship of Spikevax NOS is not affected by this report.   Concomitant and treatment medications were not reported.  Patient presented to the emergency department with two days of diplopia. While he had no prior confirmed COVID-19 infection, he had received a Moderna SARS-CoV-2 mRNA booster vaccination 16 days before the onset of diplopia (onset of symptoms occurred 14 days after the vaccination). He only had mild malaise the day after the shot. His past medical history, family history, and social history were all noncontributory.  The rest of his neurological exam was normal, including his motor function, sensation, balance, and gait examination. Although the patient refused a lumbar puncture, various blood tests were performed to check for myasthenia gravis, autoimmune neurological diseases, and ganglioside antibodies.  Fortunately, the patient's condition started to improve on the third day in the hospital without needing any immunosuppressive medications. He was discharged home shortly after. Subsequently, the only antibody that came back positive was serum Asialo-GM1 antibodies. A follow-up appointment 14 days after discharge confirmed the complete resolution of all his symptoms.  Author presented a patient who developed isolated, pupil-sparing oculomotor nerve palsy 14 days after receiving a Moderna COVID-19 booster vaccination. The positive Asialo-GM1 antibody test suggests a possible post-vaccination autoimmune reaction, but the limitations intrinsic to a single case report mean we are unable to draw definitive conclusions about the causality. Further research was needed to investigate the potential link between COVID-19 vaccination and isolated oculomotor nerve palsy.   This case was linked to US-MODERNATX, INC.-MOD-2024-771797, US-MODERNATX, INC.-MOD-2024-771798 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-771797:Patient 2 US-MODERNATX, INC.-MOD-2024-771798:Patient 3