Sex: M
Vaccine: VARZOS
Symptoms: Blister, Corneal opacity, Eye paraesthesia, Facial pain, HIV antibody negative
Clinical narrative: Suspected vaccination failure; Herpes zoster ophthalmicus; recent RZV confirmed the diagnosis of VZV (varicella zoster virus); V1-limited rash/ rash on his nasolacrimal area and forehead; paresthesia on his nasolacrimal area and forehead/ paresthesia on his left eyelid; pain and tingling on the left side of his face; pain and tingling on the left side of his face; corneal haze; The vesicles fully developed/ Vesicles limited to V1 dermatome; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 59-year-old male patient who received Herpes zoster (Zoster vaccine) for prophylaxis.   The patient's past medical history included benign prostatic hyperplasia. Concomitant products included tamsulosin.   On an unknown date, the patient received Zoster vaccine (intramuscular). On an unknown date, an unknown time after receiving Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Herpes zoster ophthalmicus) (serious criteria GSK medically significant), varicella zoster (Verbatim: recent RZV confirmed the diagnosis of VZV (varicella zoster virus)), rash (Verbatim: V1-limited rash/ rash on his nasolacrimal area and forehead), eye paresthesia (Verbatim: paresthesia on his nasolacrimal area and forehead/ paresthesia on his left eyelid), facial pain (Verbatim: pain and tingling on the left side of his face), tingling (Verbatim: pain and tingling on the left side of his face), corneal haze (Verbatim: corneal haze) (serious criteria GSK medically significant) and vesicle (Verbatim: The vesicles fully developed/ Vesicles limited to V1 dermatome). The patient was treated with amoxicillin, valaciclovir (Valacyclovir) and mupirocin. The outcome of the vaccination failure, ophthalmic herpes zoster, varicella zoster, facial pain, tingling, corneal haze and vesicle were not reported and the outcome of the rash and eye paresthesia were resolved.   The reporter considered the vaccination failure, ophthalmic herpes zoster, varicella zoster, rash, eye paresthesia, facial pain, tingling, corneal haze and vesicle to be related to Zoster vaccine.     The company considered the vaccination failure, ophthalmic herpes zoster, varicella zoster, rash, eye paresthesia, facial pain, tingling, corneal haze and vesicle to be related to Zoster vaccine.   Additional Information: GSK received date: 09-SEP-2024  A 59-year-old-man with a history of benign prostatic hyperplasia controlled with 0.4 g of tamsulosin daily, presented to the ED (emergency department). The patient was treated at an outside hospital, two days after receiving the RZV, complaining of a rash on his nasolacrimal area and forehead, limited to V1 dermatome. At the outside hospital, he was prescribed amoxicillin, valacyclovir 1 g BID (twice a day) PO, and unidentified eyedrops. The vesicles fully developed around day 9, at which point he presented to the ED since his medications were not alleviating any symptoms. The patient described pain and "tingling" on the left side of his face; however, he denied any vision changes. In the ED, he was prescribed mupirocin 2 percent TID for 10 days to prevent secondary infection. Systemic evaluation of the patient did not reveal any other signs or symptoms consistent with vaccine-related adverse events or manifestations of HZ. He was then referred for an ophthalmology consult. On day 10, he was seen by an ophthalmologist, and his valacyclovir dose was increased to full treatment of 1 g TID, which he completed within the next 10 days. During this consult, corneal haze was noted in the peripheral cornea. This did not look particularly active. 20-day follow-up: The slit lamp examination showed the corneal haze remained unchanged. The patient had finished his full dose of valacyclovir and his V1 dermatome rash had resolved. 33-day follow-up: Another slit lamp examination revealed no new intraocular inflammation and stable corneal haze. The patient's corneal haze was felt to be chronic and inactive finding, and most likely unrelated to HZ (herpes zoster).  During the ED visit, a sample was taken from the vesicles. PCR testing from this was negative for herpes simplex virus (HSV) 1 and HSV 2 but positive for VZV (varicella zoster virus). In addition, HIV (Human immunodeficiency virus) antigen/antibody tests were negative.  Differentials for the patient included HSV 1, HSV 2, and VZV. The positive VZV PCR test with a recent RZV confirmed the diagnosis of VZV.  This case was considered to be a suspected vaccination failure case, as the details regarding complete vaccination schedule was unknown.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Zoster vaccine. Ophthalmic herpes zoster and Corneal opacity are unlisted events which are considered unrelated to GSK vaccine Zoster vaccine.