Received Jul 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
Herpes zoster ophthalmicus; orbital myositis/ binocular diplopia and headache approximately two weeks after recombinant zoster vaccination; varicella-zoster virus reactivation; This serious case was reported in a literature article and described the occurrence of ophthalmic herpes zoster in a 79-year-old male patient who received Herpes zoster (Herpes Zoster vaccine) solution for injection for prophylaxis. Literature Reference. Concurrent medical conditions included hypertension, hyperlipidemia and benign prostatic hyperplasia. Additional patient notes included The patient had no prior surgical history, denied tobacco or illicit drug use, and reported occasional alcohol use. The patient had no known drug allergies. The patient denied any additional neurologic symptoms, including weakness, numbness, dysarthria, or gait instability.. Concomitant products included paracetamol (Acetaminophen), amlodipine, losartan, rosuvastatin and metoprolol tartrate. On an unknown date, the patient received the 2nd dose of Herpes Zoster vaccine. On an unknown date, 2 weeks after receiving Herpes Zoster vaccine, the patient experienced ophthalmic herpes zoster (Verbatim: Herpes zoster ophthalmicus) (serious criteria hospitalization and GSK medically significant), orbital myositis (Verbatim: orbital myositis/ binocular diplopia and headache approximately two weeks after recombinant zoster vaccination) (serious criteria hospitalization and GSK medically significant) and herpes zoster reactivation (Verbatim: varicella-zoster virus reactivation) (serious criteria hospitalization). The patient was treated with aciclovir (Acyclovir) and valaciclovir (Valacyclovir). The outcome of the ophthalmic herpes zoster, orbital myositis and herpes zoster reactivation were resolving. The reporter considered the ophthalmic herpes zoster, orbital myositis and herpes zoster reactivation to be related to Herpes Zoster vaccine. The company considered the ophthalmic herpes zoster, orbital myositis and herpes zoster reactivation to be unrelated to Herpes Zoster vaccine. Additional Information: GSK Receipt Date 06-JUL-2026. Author reported that the patient with a history of hypertension, hyperlipidemia, and benign prostatic hyperplasia presented to the emergency department with a 10-day history of gradual-onset, low-grade right-sided headache and one day of new-onset diplopia. The headache was localized to the right forehead with occasional radiation to the right cheek. The patient described the pain as mild and persistent and denied any prior similar episodes. One day prior to presentation, The patient developed binocular diplopia that was most noticeable when looking at distant objects, which The patient described as vertically stacked images that re solved with monocular occlusion. The patient also noted the development of a rash over the right forehead. The patient denied any additional neurologic symptoms, including weakness, numbness, dysarthria, or gait instability. Of note, The patient had received the patient's second dose of the recombinant zoster vaccine approximately two weeks prior to symptom onset. The patient's home medications included acetaminophen as needed, amlodipine 5 mg daily, losartan 50 mg twice daily, and rosuvastatin 5 mg nightly. The patient had no prior surgical history, denied tobacco or illicit drug use, and reported occasional alcohol use. The patient had no known drug allergies. On presentation, the patient's blood pressure was 160/74 mmHg with otherwise normal vital signs. Physical examination revealed an evolving vesicular rash across the right forehead tender to palpation. Neurologic examination was non-focal, and the patient was alert and oriented to person, place, and time. Cranial nerve evaluation revealed non-localizing binocular diplopia. Given the acute onset of diplopia, a stroke alert was activated on arrival. The patient's National Institutes of Health Stroke Scale score was 0, and thrombolytic therapy was not administered. Initial laboratory evaluation, including complete blood count and basic metabolic panel, was largely within normal limits, with the exception of mild anemia and hyperchloremia. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were within normal limits, and hemoglobin A1c (HbA1c) was 5.8percent. Given concern for a neurologic etiology, the patient was admitted for further evaluation. Computed tomography (CT) of the head without contrast showed no evidence of mass, hemorrhage, midline shift, or extra-axial fluid collection, with clear paranasal sinuses and patent basilar cisterns. Magnetic resonance imaging (MRI) of the brain without contrast demonstrated no evidence of acute infarction or other intracranial pathology, with only minimal chronic microvascular changes noted. Carotid duplex ultrasound revealed no hemodynamically significant stenosis, and transthoracic echocardiogram showed no intra-atrial shunt or patent foramen ovale. Ophthalmology was consulted due to concern for Herpes zoster ophthalmicus involving the right V1 distribution. Ophthalmologic examination on day 2 demonstrated visual acuity of 20/40 in both eyes, with pupils equal, round, and reactive to light and intraocular pressures of 15 mmHg bilaterally. Visual fields were full. Extraocular movement testing showed reduced inferior and temporal motion of the right eye, while movements in the left eye were full. Slit lamp examination confirmed the vesicular rash across the right forehead and eyebrow, with otherwise normal anterior segment findings bilaterally, including clear corneas, deep and quiet anterior chambers, and trace nuclear sclerosis of the lenses. Fundus examination revealed normal optic discs with cup-to-disc ratios of 0.5, and normal macula, vessels, and peripheral retina bilaterally. The diplopia was suspected to be secondary to orbital myositis given the absence of a localizing cranial nerve pattern. Empiric antiviral therapy with intravenous (IV) acyclovir (10 mg/kg every 8 hours) was initiated on day 2. Neurology was consulted and initially recommended Magnetic resonance imaging of the orbits with and without contrast; however, infectious disease consultation led to varicella-zoster virus polymerase chain reaction (PCR) testing, which returned positive. Orbital imaging was subsequently deferred. During hospitalization, the patient remained neurologically stable without symptom progression. the patient's diplopia persisted but did not worsen. the patient's hospital course was also notable for poorly controlled hypertension, for which amlodipine was increased to 10 mg daily, metoprolol tartrate 12.5 mg twice daily was initiated, and losartan 50 mg twice daily was continued. The patient was discharged home in stable condition after a three-day hospitalization to complete a 14 day course of valacyclovir 1 g twice daily. The patient was instructed to follow up with the patient's primary care physician within one to two weeks for blood pressure management and with the patient's ophthalmologist for close monitoring of Herpes zoster ophthalmicus and associated diplopia. In the patient, the diplopia did not follow a pattern consistent with an isolated cranial nerve palsy. The restricted inferior and temporal motion of the right eye raised clinical suspicion for orbital myositis as the primary etiology. Clinical features suggestive of orbital myositis include mechanical restriction of extraocular movement rather than neurogenic weakness, involvement of multiple muscles simultaneously, pain with eye movement, and associated proptosis. These findings support an inflammatory myopathic process rather than an isolated cranial neuropathy. The patient was started on intravenous acyclovir 10 mg/kg every 8 hours and discharged with a 14-day course of valacyclovir 1 g twice daily, consistent with favorable outcomes reported in Herpes zoster ophthalmicus -associated orbital myositis. In this case, orbital imaging was deferred following a positive varicella-zoster virus polymerase chain reaction result and the clinical course remained stable, highlighting that Magnetic resonance imaging, while diagnostically valuable, may not be necessary in all cases when Herpes zoster ophthalmicus with suspected orbital myositis was otherwise established. This case underscores the importance of maintaining clinical suspicion for Herpes zoster ophthalmicus even in the setting of recent zoster vaccination. This case illustrates herpes zoster ophthalmicus presenting with binocular diplopia and restricted extraocular movements suggestive of orbital myositis, arising in temporal association with recent recombinant zoster vaccination. This case reinforces that orbital myositis was a rare, underrecognized cause of diplopia in Herpes zoster ophthalmicus that may accompany or precede the dermatomal rash, complicating early diagnosis. This article is not available for regulatory reporting purpose due to copyright restrictions.; Sender's Comments: A case of Ophthalmic herpes zoster, Orbital myositis and Herpes zoster reactivation, 2 weeks after vaccination with the 2nd dose of Herpes Zoster vaccine, in a 79-year-old male patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology (varicella-zoster virus polymerase chain reaction (PCR) testing, which returned positive).
Benign prostatic hyperplasia; Hyperlipidemia; Hypertension
Comments: The patient had no prior surgical history, denied tobacco or illicit drug use, and reported occasional alcohol use. The patient had no known drug allergies. The patient denied any additional neurologic symptoms, including weakness, numbness, dysarthria, or gait instability.
ACETAMINOPHEN; AMLODIPINE; LOSARTAN; ROSUVASTATIN; METOPROLOL TARTRATE
Test Name: Anion Gap; Test Result: 8 {DF}; Test Name: Bicarbonate; Test Result: 24 {DF}; Test Name: Calcium; Test Result: 8.8 mg/dl; Test Name: Chloride; Result Unstructured Data: (Test Result:109 (H),Unit:mEq/L,Normal Low:98,Normal High:106); Test Name: Creatinine; Test Result: 0.89 mg/dl; Test Name: Glucose; Test Result: 84 mg/dl; Test Name: Osmolality; Result Unstructured Data: (Test Result:290 mOsm/kg H2O,Unit:unknown,Normal Low:275,Normal High:295); Test Name: Potassium; Test Result: 3.9 {DF}; Test Name: Blood pressure; Result Unstructured Data: (Test Result:160/74,Unit:mmHg,Normal Low:,Normal High:); Test Name: Sodium; Test Result: 141 {DF}; Test Name: Blood Urea Nitrogen; Test Result: 15 mg/dl; Test Name: C-reactive protein; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: CBC; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: HbA1c; Test Result: 5.8 %; Test Name: Hematocrit; Result Unstructured Data: (Test Result:40.7 (L),Unit:%,Normal Low:42,Normal High:50); Test Name: Hemoglobin; Result Unstructured Data: (Test Result:13.5 (L),Unit:g/dL,Normal Low:14,Normal High:18); Test Name: intraocular pressures; Result Unstructured Data: (Test Result:15 bilaterally,Unit:mmHg,Normal Low:,Normal High:); Test Name: metabolic panel; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: National Institutes of Health Stroke Scale score; Result Unstructured Data: (Test Result:0,Unit:unknown,Normal Low:,Normal High:); Test Name: Platelet; Result Unstructured Data: (Test Result:256,Unit:x10e3/mm3,Normal Low:150,Normal High:450); Test Name: VZV polymerase chain reaction; Result Unstructured Data: (Test Result:returned positive,Unit:unknown,Normal Low:,Normal High:); Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: vital sign measurement; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: White blood cell count; Result Unstructured Data: (Test Result:9.0,Unit:x10e3/mm3,Normal Low:4,Normal High:11); Comments: On unknown date physical examination revealed an evolving vesicular rash across the right forehead tender to palpation. Neurologic examination was non-focal, and the patient was alert and oriented to person, place, and time. Cranial nerve evaluation revealed non-localizing binocular diplopia. On unknown date Computed tomography (CT) of the head without contrast showed no evidence of mass, hemorrhage, midline shift, or extra-axial fluid collection, with clear paranasal sinuses and patent basilar cisterns. Magnetic resonance imaging (MRI) of the brain without contrast demonstrated no evidence of acute infarction or other intracranial pathology, with only minimal chronic microvascular changes noted. Carotid duplex ultrasound revealed no hemodynamically significant stenosis, and transthoracic echocardiogram showed no intra-atrial shunt or patent foramen ovale. Ophthalmologic examination on day 2 demonstrated visual acuity of 20/40 in both eyes, with pupils equal, round, and reactive to light. Visual fields were full. Extraocular movement testing showed reduced inferior and temporal motion of the right eye, while movements in the left eye were full. Slit lamp examination confirmed the vesicular rash across the right forehead and eyebrow, with otherwise normal anterior segment findings bilaterally, including clear corneas, deep and quiet anterior chambers, and trace nuclear sclerosis of the lenses. Fundus examination revealed normal optic discs with cup-to-disc ratios of 0.5, and normal macula, vessels, and peripheral retina bilaterally.