Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Intraocular pressure test, Maternal exposure during breast feeding, Optical coherence tomography, Red blood cell sedimentation rate, Retinogram
Clinical narrative: Unilateral/bilateral acute zonal occult outer retinopathy (AZOOR); Exposure during breast feeding; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE MACULAR NEURORETINOPATHY (Unilateral/bilateral acute zonal occult outer retinopathy (AZOOR)) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.        The patient's past medical history included Pregnancy and Miscarriage (Unexplained). Concurrent medical conditions included Pre-eclampsia (Prior to her Last pregnancy, the patient had two episodes of preeclampsia).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACUTE MACULAR NEURORETINOPATHY (Unilateral/bilateral acute zonal occult outer retinopathy (AZOOR)) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING BREAST FEEDING (Exposure during breast feeding). The patient was treated with DEXAMETHASONE (intravitreal) for Adverse event, at an unspecified dose and frequency. At the time of the report, ACUTE MACULAR NEURORETINOPATHY (Unilateral/bilateral acute zonal occult outer retinopathy (AZOOR)) and MATERNAL EXPOSURE DURING BREAST FEEDING (Exposure during breast feeding) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram retina: normal in both eyes. On an unknown date, C-reactive protein: 19 high, showing overactivity of the immune system. On an unknown date, Fluorescence angiogram: normal in both eyes. On an unknown date, Fundus autofluorescence: normal in both eyes, does not rule out AZOOR. On an unknown date, Intraocular pressure test: normal in both eyes. On an unknown date, Optical coherence tomography: outer retinal layer segmental disruption in left eye. On an unknown date, Red blood cell sedimentation rate: 25 High, showing overactivity of the immune system. On an unknown date, Retinogram: (Inconclusive) fixed luminance  (FL) and multi-luminance (ML)-flicker electroretinography (ERG) and MF-ERG in both eyes MF-ERG, defective areas were observed in the inferotemporal macula and temporal macula in the right and left eyes, respectively. test results we diagnosed her with bilateral AZOOR.. On an unknown date, Visual field tests: The right eye visual field is reliable and shows a nonspecific nasal defect. The left eye visual field is unreliable and shows an impressive nasal field defect.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ACUTE MACULAR NEURORETINOPATHY (Unilateral/bilateral acute zonal occult outer retinopathy (AZOOR)) to be possibly related and MATERNAL EXPOSURE DURING BREAST FEEDING (Exposure during breast feeding) to be not applicable.    Concomitant medications were not provided by the reporter.   The progressive nasal field defect was there in left eye and photopsia in both eyes of the patient. It was reported that the problem started 10 days after receiving the second recombinant mRNA vaccine (Moderna) injection. Later, she was diagnosed with unilateral AZOOR in her left eye and was subsequently treated with an intravitreal dexamethasone implant in this same eye.  The patient was recommended a combination therapy of azathioprine and cyclosporine; however, the patient preferred to first consult respective obstetrician/gynecologist prior to starting therapy as was nursing a three-month-old baby. It was believed that the intravitreal dexamethasone implant should control inflammation while the patient was nursing.  The patient has no family history of autoimmune diseases. Also had 20/20 vision in both eyes. The anterior segment and posterior segment exams were completely normal except for a yellowwhite reflex in the temporal macula of her left eye.  Company Comment: This is a literature non-study case concerning a 33-year-old female patient with a history of pre-eclampsia (prior to her Last pregnancy, the patient had two episodes of preeclampsia), and an unexplained miscarriage, and no family history of autoimmune diseases, who experienced the serious (due to medically significant) unexpected event of Acute macular neuroretinopathy. Maternal exposure during breastfeeding was also reported in the case. The event occurred approximately 10 days after the second dose of mRNA-1273 vaccine. The patient presented a progressive nasal field defect in her left eye and photopsia in both eyes 10. She was referred to a uveitis specialist, who discovered from the macular OCT test, outer retinal layer segmental disruption in her left eye. All of the blood work, which was completed by the uveitis specialist, demonstrated high ESR and CRP. As a result, she was diagnosed with unilateral acute zonal occult outer retinopathy (AZOOR) in her left eye and was subsequently treated with an intravitreal dexamethasone implant in this same eye. The patient was referred to the author for a second opinion, and at presentation, had 20/20 vision in both eyes. The anterior segment and posterior segment exams were completely normal except for a yellowwhite reflex in the temporal macula of her left eye. There was no inflammation in either the anterior chamber or the vitreous cavity. Intraocular pressure was normal in both eyes. Macular OCT of both eyes, showed a segmented and disrupted ellipsoid zone in the right eye and a very thin ellipsoid zone (absent in some areas) in her left eye. Fluorescein angiography and indocyanine green angiography appeared to be normal in both eyes. Humphrey visual field test of the right eye showed a nonspecific nasal field defect, and the left eye visual field was unreliable and showed an impressive nasal field defect. Electroretinography was abnormal. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Upon internal review on 02-Aug-2023, Significant amendment was performed to upgrade the case as per IME list. On 05-Aug-2021: Follow up received by safety 07-Aug-2021 included an email with full text article from the team and does not contain any new information. On 20-Aug-2021: Follow up received by safety 23-Aug-2021 Email with abstract received from team and does not contain any new information. On 23-Aug-2021: Follow up received by safety 25-Aug-2021 Email with abstract received from team and does not contain any new information.