Age: 69.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Visual acuity tests
Clinical narrative: Allograft rejection; This literature case was received on 11-Dec-2023, from a physician and concerned a 69-year-old, female patient.   The purpose of this article is to report three cases of corneal allograft rejection that occurred in temporal proximity to administration of the zoster subunit vaccine (RZV).  The patient's historical condition included Fuchs' endothelial dystrophy. The patient's procedures included descemet stripping endothelial keratoplasty in the left eye (oculus sinister, OS), and in the right eye (oculus dexter, OD). The patient's concomitant medications were not reported.  On an unspecified date in 2019, reported as 'one year previously', the grafts were clear and best-corrected visual acuity was 20/20 OD and 20/25 OS.  On an unspecified date in Aug-2020, the patient was vaccinated with non-company co-suspect Shingrix (varicella zoster vaccine rge (cho); dose: reported as 'first', anatomical location, route of administration and indication: not reported). The batch number was not reported.   On an unspecified date in Sep-2020, the patient was vaccinated with influenza vaccine (brand not specified; dose, anatomical location, route of administration and indication: not reported). The batch number was not reported.   On the same date, the patient was vaccinated with non-company co-suspect Shingrix (varicella zoster vaccine rge (cho); dose: reported as 'second', anatomical location, route of administration and indication: not reported). The batch number was not reported.   On an unspecified date in Oct-2020, reported as six weeks after receiving influenza vaccine and the second dose of non-company co-suspect Shingrix, the patient experienced blurring of vision in the left eye. At the time of onset of symptoms, the patient had been using topical loteprednol 0.5%, one drop, one to two times per week in both eyes.  On an unspecified date in Oct-2020, the patient presented with a one-week history of blurring of vision in the left eye. The patient's visual acuity OS was 20/70 and the conjunctiva had trace injection. The cornea had temporal stromal and epithelial edema, with 1+ cells in the anterior chamber. Intraocular pressure was 13 mm Hg. The patient denied systemic or local infection or trauma. The patient was diagnosed with allograft rejection and was treated with prednisolone acetate 1% eight times per day.   On an unspecified date in 2020, within three weeks, the anterior chamber was quied.  On an unspecified date, the patient recovered from the event. As reported, after eight weeks, the corneal edema had resolved. Vision at three months was 20/25 with no residual edema.  The reporter did not provide a causality assessment.   From results, the onset of symptoms occurred six weeks after the second RZV dose. Coexisting risk factors included history of endothelial keratoplasty in the fellow eye.  In this patient, rejection developed despite relatively high levels of topical steroid therapy: prednisolone acetate 1%.  In conclusion, RZV, which elicits a more robust immune reaction than the zoster live-attenuated vaccine, Zostavax, Merck and Co (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.  The event of 'acute allograft rejection' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance Department.  The literature citation.  Company comment: On an unspecified date in Oct-2020, reported as six weeks after receiving influenza vaccine and the second dose of non-company co-suspect Shingrix, the patient experienced blurring of vision in the left eye. The patient presented with a one-week history of blurring of vision in the left eye, and denied systemic or local infection or trauma. The patient was diagnosed with allograft rejection and was treated with prednisolone acetate 1% eight times per day. On an unspecified date, the patient recovered from the event. Causality was highly cofounded by co-suspect Shingrix vaccine. However, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related, based on plausible chronology.; Sender's Comments: On an unspecified date in Oct-2020, reported as six weeks after receiving influenza vaccine and the second dose of non-company co-suspect Shingrix, the patient experienced blurring of vision in the left eye. The patient presented with a one-week history of blurring of vision in the left eye, and denied systemic or local infection or trauma. The patient was diagnosed with allograft rejection and was treated with prednisolone acetate 1% eight times per day. On an unspecified date, the patient recovered from the event. Causality was highly cofounded by co-suspect Shingrix vaccine. However, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related, based on plausible chronology.