Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Ophthalmological examination abnormal, Transplant rejection, Vision blurred, Visual impairment
Clinical narrative: Corneal Allograft Rejection; cystoid macular edema; Eye blurring; declining vision; conjunctival injections; diffuse stromal edema/corneal edema of the left eye; Eye inflammation; Drug dose administration interval too short; This case was reported in a literature article and described the occurrence of transplant rejection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included eye injury (tennis ball injury to the eye at age 12 years), cataract (undergone cataract extraction with intraocular lens placement), glaucoma (shunt placement for glaucoma), abnormal vision (In 2018, the patient underwent penetrating keratoplasty OS with improvement of vision from 20/400 to 20/40), respiratory infection, transplant rejection (which led to irreversible graft edema) and corneal neovascularization (in one quadrant). Concomitant products included Herpes zoster (Shingrix).   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced transplant rejection (serious criteria GSK medically significant), cystoid macular edema (serious criteria GSK medically significant), blurred vision, vision decreased, conjunctival injection, corneal edema and eye inflammation. The patient was treated with difluprednate. On an unknown date, the outcome of the transplant rejection, cystoid macular edema, blurred vision, vision decreased, conjunctival injection and drug dose administration interval too short were unknown and the outcome of the corneal edema and eye inflammation were recovering/resolving.   The reporter considered the transplant rejection, cystoid macular edema, blurred vision, vision decreased, conjunctival injection, corneal edema and eye inflammation to be possibly related to Shingrix.  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of Allograft Rejection, in a Female patient of unknown age, who was vaccinated with Shingrix (GlaxoSmithKline) for prophylaxis. This case corresponds to Case 2 reported in this literature article. The patient was a woman. After a tennis ball injury to the eye at age 12 years, the patient had undergone cataract extraction with intraocular lens placement and, subsequently, shunt placement for glaucoma. In 2018, the patient underwent penetrating keratoplasty (PKP) OS with improvement of vision from 20/400 to 20/40. In March 2019, after a respiratory infection, the patient developed allograft rejection, which led to irreversible graft edema. In August 2019, repeat PKP was performed. Before surgery, the patient had superficial neovascularization of the cornea in one quadrant. No information on patient family history or concurrent condition or concomitant medication was reported.  In November 2020, the patient was vaccinated with first dose of Shingrix, and the second dose of Shingrix in late December 2020 (administration route and site unknown; batch number not provided for both). The age at vaccination was not reported but it could be between 57 or 58 years at the time of vaccination. In December 2020, the patient was noted to have a clear graft. On an unknown date, 1 week after the second dose of Shingrix vaccination, the patient had onset of blurring. Five weeks later, she reported declining vision of 3 weeks' duration. On examination, the patient had 1 to 2+ conjunctival injections and diffuse stromal edema; the vision had declined to 20/400. At the age of 58 years, the patient presented with corneal edema of the left eye. At the time of development of the corneal edema, the patient was being treated by a retina specialist with difluprednate emulsion 0.05%, 3 per day for cystoid macular edema. Allograft rejection was diagnosed. The patient was treated with difluprednate 0.05% hourly with rapid improvement of the inflammation. Improvement of inflammation occurred quickly after intense topical steroid therapy. At the 2-month follow-up, the eye was quiet, but residual corneal edema was noted.  The authors commented "It elicits a robust immune response, with both humoral and cell-mediated responses detectable 1 month after the first dose. RZV is more immunogenic than the older ZVL. It is likely that RZV may pose a greater risk for associated immune-mediated reactions, such as reactivation of zoster keratitis and corneal allograft rejection than ZVL. Identifiable potential risk factors other than the RZV were as follows: One patient had a history of a second Descemet stripping endothelial keratoplasty in the fellow eye 10 years previously. One patient had a history of 1 previous PKP that failed because of allograft rejection. The same patient also underwent removal of 1 suture before the onset of blurred vision. One drop of topical loteprednol 0.5% was administered at the time of the suture removal, and the patient was instructed to continue his previous regimen of prednisolone acetate 1% 4 per day. The third patient had 1 episode of rejection in a previous transplant. Original indications for keratoplasty were corneal endothelial dystrophy, past trauma, and keratoconus. In 2 of the 3 cases, rejection occurred despite relatively high level of topical corticosteroid therapy: difluprednate emulsion 0.05% 3 per day (for the treatment of cystoid macular edema), in 1 patient, and prednisolone acetate 1% 4 per day, in a second patient. Improvement of inflammation occurred quickly after intense topical steroid therapy in all 3 cases. Onset of symptoms of allograft rejection occurred 5 weeks after the first RZV dose in 1 patient. In the other 2 patients, blurred vision was noted 1 and 6 weeks after the second dose. It has been reported that "overall, 30% of transplanted corneas experience at least 1 episode of immune reaction."10 Therefore, observation of a chance temporal association with RZV is possible. However, with 3 cases identified within a 3-month period, it is reasonable to consider the possibility that RZV may increase the risk for corneal allograft rejection.".  This is 1 of the 3 valid cases reported in this literature article.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021GSK167255:Same reporter