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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
In a case report two women aged 66 and 83 years old were described, they developed endothelial corneal transplant rejection following administration of tozinameran [route and dose not stated].
Case 1: A 66-year-old woman, who had a medical history of well controlled HIV infection, had been receiving abacavir/dolutegravir/lamivudine. She underwent phacoemulsification, lens implantation and Descemet's membrane endothelial keratoplasty (DMEK) for Fuchs endothelial corneal dystrophy (FECD). Post-procedural investigations on day 2 and day 7 including full graft attachment, restoration of corneal transparency, central corneal thickness (CCT), best corrected visual acuity (BAVA) were satisfactory. She continued receiving dexamethasone. On post-procedural day 14, she received first dose of tozinameran [SARS-CoV-2 mRNA vaccine BNT162b2]. Seven days later, she presented to the due to acute onset of blurred vision, redness and photophobia in the right eye. At presentation, investigations showed BAVA of 6/36 in the right eye and intraocular pressure of 10mm Hg. On slit lamp examination, anterior segment findings included moderate conjunctival injection, diffuse corneal oedema, fine keratic precipitates restricted to the donor endothelium inferiorly, anterior chamber (AC) inflammation, along with a well-positioned posterior chamber intraocular lens implant. The left eye was found to be uninflamed with minimal corneal oedema secondary to FECD and early cataract. Dilated funduscopy was unremarkable for both the eyes. Anterior segment optical
coherence tomography revealed full graft attachment and CCT of 652µm, it was increased significantly in comparison to the previous CCT. AC sample was evaluated for the virus-induced corneal inflammation; however, it was unremarkable. It was suggesting acute endothelial graft rejection. The woman's frequency of receiving dexamethasone was increased. Three days later, she showed a significant improvement. The transplant function continued to improve, with clear cornea and BCVA of 6/6. Later, frequency of the dexamethasone was decreased. Four weeks post-rejection onset, visual acuity was good without active inflammation.
Case 2: A 83-year-old woman underwent DMEK and cataract surgery for FECD in the right eye 6 years previously and same procedure in the left eye 3 years previously with replacement of an earlier Descemet's stripping enothelial keratoplasty graft. Investigations revealed BAVA of 6/6 in both eyes (her dexamethasone was discontinued). She received both doses of both doses of the tozinameran [SARS-CoV-2 mRNA vaccine BNT162b2]. Two months after first dose (3 weeks after second dose), she presented due to sudden onset of bilateral blurred vision, pain, photophobia and redness. At presentation, the investigation showed BAVA of 6/24 in the right eye and 6/12 in the left eye. Slit lamp examination included bilateral circumcorneal injection, keratic precipitates, AC inflammation and normal intraocular pressure. In the right eye, anterior segment was prominently inflamed, consistently with symptoms. CCT of the right and left eye was found to be 660µm and 622µm, respectively. Finally, she was diagnosed with bilateral simultaneous acute endothelial graft rejection. The woman started receiving dexamethasone. Seven days later on follow-up, signs of inflammation improved significantly, both grafts were functioning well and BCVA was found to be 6/6 in both eyes. The frequency of dexamethasone was reduced.