Received Mar 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 3 | — | — |
Acute Macular Neuroretinopathy; the event exacerbated by mRNA COVID-19 booster vaccination; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE MACULAR NEURORETINOPATHY (Acute Macular Neuroretinopathy) and CONDITION AGGRAVATED (the event exacerbated by mRNA COVID-19 booster vaccination) in a 79-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. LITERATURE REFERENCE: The patient's past medical history included COVID-19. Concurrent medical conditions included Arthritis, Hypertension, Occipital neuralgia, Neuropathy, Basal cell carcinoma and Herpes labialis (intermittent). Concomitant products included Aciclovir (Acyclovir) for Herpes labialis, Felodipine, Gabapentin, Hydroxyzine hydrochloride (Hydroxyzine HCL) and Triamcinolone acetonide for an unknown indication. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACUTE MACULAR NEURORETINOPATHY (Acute Macular Neuroretinopathy) (seriousness criterion medically significant) and CONDITION AGGRAVATED (the event exacerbated by mRNA COVID-19 booster vaccination) (seriousness criterion medically significant). The patient was treated with Prednisone (oral use) at an unspecified dose and frequency; Triamcinolone acetonide (Kenalog) (ophthalmic) at an unspecified dose and frequency and Valaciclovir hydrochloride (Valacyclovir) (oral use) for Herpes labialis, at an unspecified dose and frequency. At the time of the report, ACUTE MACULAR NEURORETINOPATHY (Acute Macular Neuroretinopathy) and CONDITION AGGRAVATED (the event exacerbated by mRNA COVID-19 booster vaccination) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram retina: OD: consistent with a diagnosis of acute macular neuroretinopathy. and OD: demonstrated temporal deep retinal/RPE hyperfluorescence and staining; there was no evidence of disc leakage/staining and no evidence of retinal vasculitis.. On an unknown date, Blood immunoglobulin G: High for HSV-1 and VZV. On an unknown date, Blood immunoglobulin M: Normal. On an unknown date, Fluorescence angiogram: OD: consistent with a diagnosis of acute macular neuroretinopathy. and OD: ICG angiography was unrevealing without choroidal vascular abnormalities.. On an unknown date, Fundus autofluorescence: OD: consistent with a diagnosis of acute macular neuroretinopathy. and OD: demonstrated hyperautofluorescence of the central and temporal macula. On an unknown date, Imaging procedure: OD: demonstrated hyporeflectance temporal to the fovea OD. 2 weeks after initial presentation OCT showed paracentral disruption of the ellipsoid zone (EZ) and interdigitation zone (IZ) disruption and infrared imaging demonstrates hyporeflectance temporal to the fovea., 4 months after presentation infrared imaging showed increased size and prominence of the hyporeflectivity now involving the fovea. and 8 months after presentation, 1 week post third vaccine, infrared imaging revealed increased size and prominence of the hyporeflectivity.. On an unknown date, Laboratory test: Laboratory evaluation for infection, autoimmune, or inflammatory systemic origin was normal.. On an unknown date, Optical coherence tomography: Optical coherence tomography (OCT) of macula OD demonstrated hyporeflectance of the photoreceptor layer, ellipsoid zone (EZ) attenuation, and outer nuclear layer (ONL) thinning. Consistent with a diagnosis of acute macular neuroretinopathy. OCT OS was normal., Four months after presentation, OCT macula was unchanged and infrared OCT OD demonstrated an increase in size and prominence of the hyporeflectivity now involving the fovea. OCT showed decreased EZ and IZ disruption with mild outer nuclear layer thinning., 8 months after presentation, OCT shows unchanged mild EZ and IZ disruption with increased outer nuclear layer (ONL) thinning., 9 months following presentation, revealed marked increase of infrared imaging hyporeflectance and OCT EZ and IZ attenuation and continued ONL thinning OD and 15 months following presentation, demonstrated decreased areas of EZ and IZ disruption but with persistent EZ/IZ temporal attenuation and substantial ONL thinning and decreased infrared imaging hyporeflectance of the temporal macula. On an unknown date, Paracentesis eye: (Negative) Aqueous paracentesis was negative for HSV, HZV and other viruses. On an unknown date, Plasminogen: (Negative) T.PA testing was negative ruling out syphilic outer retinitis and acute syphilitic placoid retinitis.. On an unknown date, Retinogram: Fundus examination was normal OU, color photography consistent with a diagnosis of acute macular neuroretinopathy. and Ultra wide-field color photography OD revealed faint darkening of the deep retina/RPE region corresponding to the area of infrared OCT hyporeflectance.. On an unknown date, Visual acuity tests: 20/30 OU and 20/25 OD, 15 months after presentation. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered ACUTE MACULAR NEURORETINOPATHY (Acute Macular Neuroretinopathy) and CONDITION AGGRAVATED (the event exacerbated by mRNA COVID-19 booster vaccination) to be related. It was reported that patient denied travel and drug use. Patient developed a central scotoma OD two weeks after his second vaccination of the Moderna COVID-19 mRNA vaccine. There was no change in symptoms OD after oral prednisone and subtenons kenalog were prescribed by an outside ophthalmologist. Four months after presentation, examination was unchanged with persistent symptoms. Eight months after presentation the patient received his third vaccination of Moderna COVID-19 mRNA vaccine. One week after this third vaccination, the patient reported worsening of symptoms OD. Nine months after initial symptoms and 1 month after the third vaccine, the patient presented to clinic. Given the history of herpes labialis and the high viral IG titers the patient was switched from acyclovir to valacyclovir orally. Valacyclovir was stopped and a diagnosis of AMN was made. With observation and no treatment, 15 months after presentation and 5 months after the third vaccine, symptoms improved.; Reporter's Comments: Taking into consideration plausible temporal relationship and that the patient's condition even worsened after third vaccination, the causality cannot be excluded and the event is assessed as related to the suspect product. The benefit-risk relationship of the product is not affected by this report.
Arthritis; Basal cell carcinoma; Herpes labialis (intermittent); Hypertension; Neuropathy; Occipital neuralgia
Medical History/Concurrent Conditions: COVID-19
Felodipine; Gabapentin; Hydroxyzine HCL; Triamcinolone acetonide; Acyclovir
Test Name: Ultra wide-field fluorescein angiography; Result Unstructured Data: OD: consistent with a diagnosis of acute macular neuroretinopathy.; Test Name: Ultra wide-field fluorescein angiography; Result Unstructured Data: OD: demonstrated temporal deep retinal/RPE hyperfluorescence and staining; there was no evidence of disc leakage/staining and no evidence of retinal vasculitis.; Test Name: IgG; Result Unstructured Data: High for HSV-1 and VZV; Test Name: IgM; Result Unstructured Data: Normal; Test Name: ICG angiography; Result Unstructured Data: OD: consistent with a diagnosis of acute macular neuroretinopathy.; Test Name: ICG angiography; Result Unstructured Data: OD: ICG angiography was unrevealing without choroidal vascular abnormalities.; Test Name: Ultra wide-field fundus autofluorescence photography; Result Unstructured Data: OD: consistent with a diagnosis of acute macular neuroretinopathy.; Test Name: Ultra wide-field fundus autofluorescence photography; Result Unstructured Data: OD: demonstrated hyperautofluorescence of the central and temporal macula; Test Name: Infrared imaging; Result Unstructured Data: OD: demonstrated hyporeflectance temporal to the fovea OD. 2 weeks after initial presentation OCT showed paracentral disruption of the ellipsoid zone (EZ) and interdigitation zone (IZ) disruption and infrared imaging demonstrates hyporeflectance temporal to the fovea.; Test Name: Infrared imaging; Result Unstructured Data: 4 months after presentation infrared imaging showed increased size and prominence of the hyporeflectivity now involving the fovea.; Test Name: Infrared imaging; Result Unstructured Data: 8 months after presentation, 1 week post third vaccine, infrared imaging revealed increased size and prominence of the hyporeflectivity.; Test Name: Laboratory evaluation; Result Unstructured Data: Laboratory evaluation for infection, autoimmune, or inflammatory systemic origin was normal.; Test Name: Optical coherence tomography; Result Unstructured Data: Optical coherence tomography (OCT) of macula OD demonstrated hyporeflectance of the photoreceptor layer, ellipsoid zone (EZ) attenuation, and outer nuclear layer (ONL) thinning. Consistent with a diagnosis of acute macular neuroretinopathy. OCT OS was normal.; Test Name: Optical coherence tomography; Result Unstructured Data: Four months after presentation, OCT macula was unchanged and infrared OCT OD demonstrated an increase in size and prominence of the hyporeflectivity now involving the fovea. OCT showed decreased EZ and IZ disruption with mild outer nuclear layer thinning.; Test Name: Optical coherence tomography; Result Unstructured Data: 8 months after presentation, OCT shows unchanged mild EZ and IZ disruption with increased outer nuclear layer (ONL) thinning.; Test Name: Optical coherence tomography; Result Unstructured Data: 9 months following presentation, revealed marked increase of infrared imaging hyporeflectance and OCT EZ and IZ attenuation and continued ONL thinning OD; Test Name: Optical coherence tomography; Result Unstructured Data: 15 months following presentation, demonstrated decreased areas of EZ and IZ disruption but with persistent EZ/IZ temporal attenuation and substantial ONL thinning and decreased infrared imaging hyporeflectance of the temporal macula; Test Name: Aqueous paracentesis; Test Result: Negative ; Test Name: T.PA testing; Test Result: Negative ; Test Name: Fundus examination; Result Unstructured Data: Fundus examination was normal OU; Test Name: Ultra wide-field color photography; Result Unstructured Data: color photography consistent with a diagnosis of acute macular neuroretinopathy.; Test Name: Ultra wide-field color photography; Result Unstructured Data: Ultra wide-field color photography OD revealed faint darkening of the deep retina/RPE region corresponding to the area of infrared OCT hyporeflectance.; Test Name: Visual acuity; Result Unstructured Data: 20/30 OU; Test Name: Visual acuity; Result Unstructured Data: 20/25 OD, 15 months after presentation