Sex: M
Vaccine: VARZOS
Symptoms: Keratoplasty, Transplant rejection, Vision blurred
Clinical narrative: Corneal Allograft Rejection; Keratic precipitates; conjunctival injections; diffuse stromal edema; Eye inflammation; blurred vision; This case was reported in a literature article and described the occurrence of transplant rejection in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. (Allograft Rejection Associated With Herpes Zoster Recombinant Adjuvanted Vaccine. Cornea 2021)  The patient's past medical history included keratoconus (underwent PKP OS in 2013 ), transplant rejection (1 episode of allograft rejection, recovered, and then failed after several years) and bullous keratopathy (in July 2020 with bullous keratopathy OS with visual acuity of count fingers at 3 ft). Concomitant products included Herpes zoster (Shingrix), loteprednol, gentamicin, prednisolone acetate and moxifloxacin.   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than 3 weeks after receiving Shingrix, the patient experienced transplant rejection (serious criteria GSK medically significant), keratic precipitates (serious criteria GSK medically significant), blurred vision, conjunctival injection, corneal edema and eye inflammation. The patient was treated with prednisolone acetate. On an unknown date, the outcome of the transplant rejection, keratic precipitates and conjunctival injection were unknown and the outcome of the blurred vision was recovered/resolved and the outcome of the corneal edema was not recovered/not resolved and the outcome of the eye inflammation was recovering/resolving.   The reporter considered the transplant rejection, keratic precipitates, blurred vision, 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 Zoster subunit vaccine (RZV)-associated corneal allograft rejection, in a Male patient of unknown age, who was vaccinated with Shingrix (GlaxoSmithKline) for prophylaxis. This case corresponds to Case 3 reported in this literature article.  The patient was a man who underwent PKP OS in 2013 for keratoconus. The graft underwent 1 episode of allograft rejection, recovered, and then failed after several years. The patient was referred in July 2020 with bullous keratopathy OS with visual acuity of count fingers at 3 ft.  The patient did not have previous history of viral keratitis or an episode of herpes zoster of any dermatome. No information on patient family history or concurrent condition or concomitant medication was reported.  In September 2020, the patient was vaccinated with first dose of Shingrix (administration route and site unknown; batch number not provided). In November 2020, the transplant was clear. One loose suture was removed. At that time, 1 drop each of topical loteprednol 0.1% and gentamicin 0.3% was instilled, and the patient was instructed to continue his regimen of prednisolone acetate 1% 4 per day and moxifloxacin 0.5% 2 per day. In December 2020, the patent received the second dose of Shingrix (administration route and site unknown; batch number not provided). The age at vaccination was not reported but it could be between 52 or 53 years at the time of vaccination.  On an unknown date, 5 weeks after the first dose and 3 weeks before the second dose of vaccination, the patient had onset of symptoms. In December 2020, the patient presented with a complaint of blurred vision of 3 weeks' duration. The patient had 1+ conjunctival injections and 2+ diffuse stromal edema with keratic precipitates. The patient denied ocular or systemic infection or trauma. Corneal allograft rejection was diagnosed. The patient was treated with prednisolone acetate 1% one drop every hour with rapid improvement of inflammation but persistence of edema because of the 2-month follow-up visit. In early January 2021, the patient was queried regarding vaccination history; the patient revealed that time patient revealed about having first Shingrix (RZV) dose in September 2020 and the second injection in December 2020.  The author 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.".  The author concluded "RZV, which elicits a more robust immune reaction than the zoster live-attenuated vaccine, ZVL, may increase the risk of allograft rejection in immunocompetent patients with preexisting corneal endothelial or penetrating transplants. Based on the available data, it may be reasonable to increase the topical corticosteroid regimen before the first dose, until approximately 3 months after the second dose of ZVL".  This is 1 of the 3 valid cases reported in this literature article.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021GSK167255:Same reporter