Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Intraocular pressure test normal, Macular scar, Malaise, Metamorphopsia
Clinical narrative: Uveitis; acute decrease in vision in the right eye; new metamorphopsia in the left eye (OS).; swelling at the injection site; Chills; malaise; fever; tinnitus; temporal thinning of the optic nerve; atrophic macular scars; yellow chorioretinal lesion; retinal lesion; choroidal neovascular membrane; This case was reported in a literature article and described the occurrence of uveitis in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included choroiditis. Previously administered products included methotrexate (10 mg oral (p.o.) weekly).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced uveitis (serious criteria GSK medically significant and other: serious as per reporter), vision decreased (serious criteria other: serious as per reporter), metamorphopsia (serious criteria other: serious as per reporter), injection site swelling (serious criteria other: serious as per reporter), chills (serious criteria other: serious as per reporter), malaise (serious criteria other: serious as per reporter), fever (serious criteria other: serious as per reporter), tinnitus (serious criteria other: serious as per reporter), optic nerve disorder (serious criteria other: serious as per reporter), macular scar (serious criteria other: serious as per reporter), chorioretinal disorder (serious criteria other: serious as per reporter), retinal disorder (serious criteria other: serious as per reporter) and choroidal neovascularization (serious criteria GSK medically significant and other: serious as per reporter). The patient was treated with prednisone, methotrexate and bevacizumab. On an unknown date, the outcome of the uveitis, vision decreased, metamorphopsia, injection site swelling, chills, malaise, fever, tinnitus, macular scar, chorioretinal disorder, retinal disorder and choroidal neovascularization were unknown and the outcome of the optic nerve disorder was recovered/resolved.   The reporter considered the uveitis, vision decreased, metamorphopsia, injection site swelling, chills, malaise, fever, tinnitus, optic nerve disorder, macular scar, chorioretinal disorder, retinal disorder and choroidal neovascularization to be related to Shingrix.  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of uveitis reactivation in a 57-years-old female patient, who was vaccinated with Shingrix (GlaxoSmithKline) for prophylaxis. This case corresponds to case 1 reported in this literature article. The patient was woman with a history of bilateral multifocal choroiditis controlled on methotrexate 10 mg oral (p.o.) weekly. No information on patient's family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received 1st dose of Shingrix (administration route and site unspecified; batch number not provided). The age of vaccination was not provided but it could be 56 years or 57 years. On an unspecified date, 5 days after the 1st dose of vaccination, the patient presented with an acute decrease in vision in the right eye (OD) and new metamorphopsia in the left eye (OS). The patient also reported upper arm swelling at the injection site, chills, malaise, subjective fever, and tinnitus that started 24 hours after the RZV injection. On examination, it was measured count fingers vision eccentrically OD (baseline acuity 20/40) and 20/20-2 vision OS with correction. Intraocular pressure was within normal limits in both eyes (OU). Pupils were equal, round, and reactive to light, without evidence of a relative afferent pupillary defect. On slit-lamp exam it was noted a quiescent anterior segment OU, an occasional anterior vitreous cell OD, and no vitreous haze in either eye. In the right eye, stable posterior segment findings were seen including peripapillary atrophic scarring with temporal thinning of the optic nerve, confluent circular punched-out atrophic macular scars with a small spared foveal region, and vessel attenuation. In the left eye, a linear yellow scar was seen temporal to the fovea and a new yellow chorioretinal lesion adjacent to this scar. [Right and left eye color fundus photographs prior to RZV vaccination demonstrated chorioretinal scarring from prior inflammation. Photos after RZV showed stability right eye and a new active inflammatory lesion in the temporal macula of the left eye]. By fundus autofluorescence, stable hypoautofluorescence was seen in the area of prior retinal scars OD and a new area of hyperautoflurorescence at the site of the new lesion OS. [Fundus autofluorescence prior to RZV showed areas of hypoautofluorescence in both eyes with small peripapillary hyperautofluorescent spots in the left eye. Fundus autofluorescence imaging after RZV demonstrated stability right eye and new hyperautofluorescence at the active lesion in the left eye]. Despite the decrease in vision OD, there was no change on macular ocular coherence tomography (OCT) compared to previously identified atrophy and scarring. On macular OCT OS, it was noted a new outer retinal lesion temporal to prior residual scar. [Optical Coherence Tomography (OCT) of the right and left eyes with a transverse cut showed scarring in areas of prior inflammation. OCT taken one week after RZV vaccination demonstrated a new chorioretinal lesion in the temporal macula of the left eye, with subsequent improvement following treatment with oral corticosteroids]. The patient was started on 60 mg of oral prednisone daily and continued methotrexate. On follow-up examination one week later the patient endorsed decreased metamorphopsia in the left eye. Visual acuity was improved to 20/250 OD and remained at 20/20-2 OS. Ocular examination remained stable OD and the new lesion noted at prior examination OS was less elevated. The patient underwent a prednisone taper over two months without development of recurrent inflammation; however, she developed a secondary choroidal neovascular membrane at the edge of the new scar requiring treatment with intravitreal bevacizumab. The authors commented, "The RZV is an adjuvanted subunit vaccine for immunization against herpes zoster. RZV contains recombinant VZV glycoprotein E and the adjuvant AS01B, which is composed of two immunostimulants: a toll-like receptor 4 agonist (3-O-desacyl-40-monophosphoryl lipid) and a saponin derived molecule QS21 (from the South American tree Quillaja saponaria). The adjuvant induces an innate immune-cell mediated response, which enhances glycoprotein E antigen presentation to T cells and induces increased production of antibodies and CD4+ T cells specific to the VZV glycoprotein E. Here, we present a spectrum of cases with uveitis activation in patients with previously controlled ocular inflammation following vaccination with the RZV. Viral DNA from previous zoster infection has been detected in corneal tissue up to eight years following the initial clinical presentation with herpes zoster ophthalmicus. One possible mechanism for post-RZV ocular inflammation is that the cell-mediated response to RZV vaccination reacts with this residual viral DNA which results in reactivation of viral keratitis or potentially keratouveitis. We propose this as the possible cause for recurrent inflammation in our third case. The mechanism for reactivation of uveitis in our other two cases is less clear. We hypothesize that in case 1, the patient with longstanding multifocal choroiditis who was controlled on immunosuppression, the upregulation of humoral and cell-mediated responses following vaccination may have resulted in reactivation of immune cells directed against uveal antigens in addition to the desired response against the VZV glycoprotein. The uveitis reactivation in case 2 is consistent with a viral process, particularly given the keratitis. The underlying etiology may be a failure of vaccination since the patient's prior uveitis presentation, which was a bilateral process without keratitis that was well controlled with short courses of topical corticosteroids, was not consistent with a viral etiology. Despite the possibility of uveitis reactivation following RZV, RZV vaccination is an important component of preventative health. The presented cases should not deter patients and physicians from recommending the RZV vaccine; RZV is efficacious in preventing herpes zoster and postherpetic neuralgia. Rather, this report highlights the importance of ensuring primary care providers are aware of a patient's history of immune-mediated eye disease. We recommend that patients with a history of uveitis discuss plans for RZV vaccination with their ophthalmologist and primary care provider in advance, so appropriate post-vaccination ocular monitoring occurs." The authors concluded, "Uveitis recurrence is an infrequent but serious potential ocular side effect of recombinant zoster vaccination. Reactivation of uveitis is an uncommon complication of RZV vaccination." This is 1 of the 3 valid cases reported in the same literature article.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021GSK140938:Same reporter US-GLAXOSMITHKLINE-US2021GSK140939:Same reporter