Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
right-sided scalp discoloration; vesicular rash; right-sided sore throat; tonsillar exudate; he had a decreased gag reflex; tenderness to the preauricular and cervical chain lymph nodes; right tonsil was enlarged without exudate; dermatomal rash; suspected vaccination failure; Herpes zoster ophthalmicus / VZV reactivation; herpes zoster infection/Varicella zoster virus reactivation; cranial nerve VI palsy; acute double vision / diplopia; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 82-year-old male patient who received Herpes zoster (Zoster vaccine) for prophylaxis. Literature Reference: Co-suspect products included Herpes zoster (Zoster vaccine) for prophylaxis. The patient's past medical history included shingles (Years prior to his presentation). Previously administered products included zoster vaccine with an associated reaction of no adverse event (live zoster vaccine). Concurrent medical conditions included keratoconus, nuclear cataract (ophthalmology clinic), thyroid gland cancer, thyroidectomy, prostate cancer, radical retropubic prostatectomy, radioactive iodine therapy, hyperlipidemia, hypertension, mycobacterium avium complex infection, bronchiectasis and asthma. Additional patient notes included He had no vision changes, ear pain, ear drainage, headache, anosmia, or nose lesions. Concomitant products included sulfamethoxazole;trimethoprim. In 2019, the patient received Zoster vaccine. In 2018, the patient received Zoster vaccine. On an unknown date, an unknown time after receiving Zoster vaccine and Zoster vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Herpes zoster ophthalmicus / VZV reactivation) (serious criteria GSK medically significant), herpes zoster (Verbatim: herpes zoster infection/Varicella zoster virus reactivation), vith nerve palsy (Verbatim: cranial nerve VI palsy) (serious criteria GSK medically significant), double vision (Verbatim: acute double vision / diplopia), skin discoloration (Verbatim: right-sided scalp discoloration), vesicular rash (Verbatim: vesicular rash), sore throat (Verbatim: right-sided sore throat), tonsillar exudate (Verbatim: tonsillar exudate), gagging (Verbatim: he had a decreased gag reflex), lymph node tenderness (Verbatim: tenderness to the preauricular and cervical chain lymph nodes), swollen tonsils (Verbatim: right tonsil was enlarged without exudate) and rash (Verbatim: dermatomal rash). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure, ophthalmic herpes zoster, herpes zoster, vith nerve palsy, skin discoloration, vesicular rash, sore throat, tonsillar exudate, gagging, lymph node tenderness and swollen tonsils were not reported and the outcome of the double vision was resolved (duration 3 days) and the outcome of the rash was resolving. The reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster, vith nerve palsy, double vision, skin discoloration, vesicular rash, sore throat, tonsillar exudate, gagging, lymph node tenderness, swollen tonsils and rash to be related to Zoster vaccine and Zoster vaccine. The company considered the vaccination failure, herpes zoster, double vision, skin discoloration, vesicular rash, sore throat, tonsillar exudate, gagging, lymph node tenderness, swollen tonsils and rash to be related to Zoster vaccine and Zoster vaccine. The company considered the ophthalmic herpes zoster and vith nerve palsy to be unrelated to Zoster vaccine and Zoster vaccine. Additional Information: GSK Receipt Date: 25-Mar-2024 The author presented an 82-year-old man with a past ocular history of keratoconus and bilateral nuclear sclerotic cataracts presented to the ophthalmology clinic with a 3-day history of acute double vision His past medical history was remarkable for thyroid cancer status post thyroidectomy and radioactive iodine, prostate cancer status post radical retropubic prostatectomy, hyperlipidemia, hypertension, severe asthma, and bronchiectasis, as well as history of pulmonary mycobacterium avium-intracellulare superimposed on pulmonary norcardiosis, for which he was on chronic trimethoprim/sulfamethoxazole and followed closely by infectious disease. Notably, he was HIV negative and with no other underlying immunologic or immunosuppressive conditions. Years prior to his presentation, he had shingles of his left flank. He received the live zoster vaccine in 2011 and the recombinant zoster vaccine in 2018 and 2019. Fourteen days prior to the onset of diplopia, he was seen by infectious disease for right-sided scalp discoloration and vesicular rash that began approximately 1 week after he had a right-sided sore throat with white, tonsillar exudate. On exam, he had a decreased gag reflex, tenderness to the preauricular and cervical chain lymph nodes, and the right tonsil was enlarged without exudate. A rapid strep test was negative. He had no vision changes, ear pain, ear drainage, headache, anosmia, or nose lesions. He was diagnosed with Herpes zoster ophthalmicus (HZO) and treated with a 10-day course of oral valacyclovir. The infectious disease specialist believed the sore throat was related to zoster polyneuropathy of cranial nerve IX and X. When presenting to the ophthalmology clinic, the patient described his double vision as constant, binocular, and horizontal. He stated that it became worse when looking right, and he experienced notable improvement when looking left. His visual acuity was 20/50 in each eye, and both pupils were equal and reactive without an afferent pupillary defect. Confrontation visual fields were full in both eyes. Extraocular movements were notable for limited abduction of the right eye. Extraocular movements were normal and full in the left eye. Slit lamp exam was negative for eyelid vesicular lesions, conjunctivitis, keratitis including dendritic lesions, and uveitis. He was diagnosed with a cranial nerve VI palsy of the right eye secondary to herpes zoster infection. Since he already completed a course of antiviral therapy, it was decided to forego any further treatment, especially given evidence of disease regression with the healing of the dermatomal rash. Oral steroids were not prescribed. Close observation and follow-up were recommended. Return precautions, including worsening double vision, decreasing vision, eye pain, light sensitivity, and eye redness, were reviewed with the patient. At his follow-up, he reported the double vision resolved spontaneously approximately 3 to 4 weeks after the onset of the symptoms. This case was considered as suspected vaccination failure since the details regarding vaccination scheduled and TTO were unknown. This article is not available for regulatory reporting purpose due to copyright restriction. Upon internal review the case was updated on: 26-Aug-2024. Suspect product coding was updated. Summary of Changes: Product tab updated.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Zoster vaccine. Ophthalmic herpes zoster and VIth nerve paralysis are unlisted events which are considered unrelated to GSK Zoster vaccine.
Asthma; Bronchiectasis; Hyperlipidemia; Hypertension; Keratoconus; Mycobacterium avium complex infection; Nuclear cataract (ophthalmology clinic); Prostate cancer; Radical retropubic prostatectomy; Radioactive iodine therapy; Thyroid gland cancer; Thyroidectomy
Medical History/Concurrent Conditions: Shingles (Years prior to his presentation); Comments: He had no vision changes, ear pain, ear drainage, headache, anosmia, or nose lesions
SULFAMETHOXAZOLE;TRIMETHOPRIM
Test Name: gag reflex test; Result Unstructured Data: (Test Result:he had a decreased,Unit:unknown,Normal Low:,Normal High:); Test Name: HIV test; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Name: Slit lamp exam; Result Unstructured Data: (Test Result:was negative,Unit:unknown,Normal Low:,Normal High:); Test Name: rapid strep test; Result Unstructured Data: (Test Result:was negative,Unit:unknown,Normal Low:,Normal High:); Test Name: visual acuity; Result Unstructured Data: (Test Result:20/50 in each eye,Unit:unknown,Normal Low:,Normal High:)