Sex: F
Vaccine: VARZOS
Symptoms: HIV test negative, Hepatitis A antigen negative, Hepatitis A virus test, Hepatitis B antigen, Hepatitis B test negative
Clinical narrative: oculomotor nerve palsy; sharp and intermittent left-eye pain; inability to move her left eye properly/ inability to adduct her left eye or move it up or down; she had complete ptosis of the left eyelid; The left eye was pointed downward and outward; the abnormalities in her eye muscles; This serious case was reported in a literature article and described the occurrence of iiird nerve palsy in a 69-year-old female patient who received Herpes zoster (Zoster vaccine) for prophylaxis. Literature Reference.   Concurrent medical conditions included hyperlipidemia, osteoporosis and open angle glaucoma. Additional patient notes included The right eye was within normal limits with no deficit. The patient denied pain in the area or any previous trauma, fever, or chills during the last days leading to the presentation.   On an unknown date, the patient received Zoster vaccine. On an unknown date, 1 month after receiving Zoster vaccine, the patient experienced iiird nerve palsy (Verbatim: oculomotor nerve palsy) (serious criteria hospitalization and GSK medically significant), eye pain (Verbatim: sharp and intermittent left-eye pain) (serious criteria hospitalization), eye movement disorder (Verbatim: inability to move her left eye properly/ inability to adduct her left eye or move it up or down) (serious criteria hospitalization), eyelid ptosis (Verbatim: she had complete ptosis of the left eyelid) (serious criteria hospitalization), downward deviation of eyes (Verbatim: The left eye was pointed downward and outward) (serious criteria hospitalization and GSK medically significant) and eye abnormality (Verbatim: the abnormalities in her eye muscles) (serious criteria hospitalization). The patient was treated with paracetamol (Acetaminophen) and prednisone. The outcome of the iiird nerve palsy, eye pain, eye movement disorder, eyelid ptosis, downward deviation of eyes and eye abnormality were resolved.   The reporter considered the iiird nerve palsy, eye pain, eye movement disorder, eyelid ptosis, downward deviation of eyes and eye abnormality to be related to Zoster vaccine.     The company considered the iiird nerve palsy, eye pain, eye movement disorder, eyelid ptosis, downward deviation of eyes and eye abnormality to be unrelated to Zoster vaccine.   Additional Information: GSK Receipt Date: 30-May-2024 The author reported a case of a 69-year-old female with a past medical history of hyperlipidemia, osteoporosis, and open-angle glaucoma presented to the emergency department (ED) three weeks after receiving the zoster vaccine. She reported sharp and intermittent left-eye pain, graded at 6/10 on the pain scale, radiating to the left temporal region, and worsening when leaning forward and improving when lying down for approximately one week. In the ED, the patient's ophthalmic examination was unremarkable. Intra-ocular pressure was within normal limits in both eyes, and the pain eventually subsided. She noted that acetaminophen provided relief from the pain. The patient was subsequently discharged to follow up with her primary care doctor. One week later, the patient presented to the clinic complaining of an inability to move her left eye properly. On neurological examination, she had complete ptosis of the left eyelid and an inability to adduct her left eye or move it up or down. The left eye was pointed downward and outward, and the pupil was reactive to light. The right eye was within normal limits with no deficit. The patient denied pain in the area or any previous trauma, fever, or chills during the last days leading to the presentation. The rest of the neurological examination was within normal limits (no focal deficits). An isolated third nerve palsy (oculomotor nerve palsy) was diagnosed. The patient reported that the abnormalities in her eye muscles occurred two to three days before presenting to the clinic. She did not have any active pain at that time. A neurological evaluation was requested, and several laboratory studies and imaging were ordered, including a complete blood count, comprehensive metabolic panel, lipid panel, hemoglobin A1C, and thyroid stimulating hormone (TSH). The results of these tests were all within normal limits. Laboratory studies showed negative/non-reactive results for antinuclear antibodies; hepatitis A, B, and C antigens; rheumatoid factor; erythrocyte sedimentation rate; C-reactive protein; human immunodeficiency virus; measles, mumps, and rubella (titers); anti-double-stranded deoxyribonucleic acid (anti-DNA); and syphilis. However, positive results were seen for anticardiolipin antibody (AB), IgM, and ferritin, which were elevated. Additionally, varicella-zoster AB, IgM levels were elevated Subsequently, brain magnetic resonance imaging and brain magnetic resonance angiography were performed to rule out any anatomic cause of the current illness that would explain the symptoms. However, imaging did not show any space-occupying lesions or aneurysms Following neurology recommendations, a lumbar puncture was performed. CSF glucose, CSF protein, cell count, protein electrophoresis, and oligoclonal banding were all either negative or within normal limits. Given the results, as well as the patient's history and physical examination, the diagnosis of isolated third nerve palsy, most likely secondary to the zoster vaccine, was made. The patient was subsequently started on a seven-week prednisone taper. By the fourth week of treatment, the patient's palsy was mainly resolved, and she was completely asymptomatic by the end of the taper. It is important to note that the ambulatory care clinic has followed the patient for more than 13 years, with all chronic conditions controlled and within the range of medical guidelines. The Adverse Drug Reaction (ADR) Probability Scale was performed. The patient scored a 6, indicating that the vaccine is likely responsible for the ADR in this case. It cannot be classified as a definite ADR because the drug cannot be established in body fluids or tissues, and no reexposure was performed. This article is not available for regulatory reporting purpose due to copyright restriction; Sender's Comments: IIrd nerve paralysis, Eye pain, Eye movement disorder, Eyelid ptosis, Gaze palsy and  Eye disorder are unlisted events which is considered unrelated to GSK Zoster vaccine.