Age: 71.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Chest X-ray, Fluorescence angiogram, Fundoscopy, Fundus autofluorescence
Clinical narrative: COVID-19; Multiple evanescent white dot syndrome; mild malaise; soreness at the site of injection; This literature-non-study case was reported in a literature article and describes the occurrence of RETINAL WHITE DOTS SYNDROME (Multiple evanescent white dot syndrome) and COVID-19 (COVID-19) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.       Co-suspect product included non-company product INFLUENZA VACCINE (INFLUENZA VIRUS VACCINE) for Influenza immunisation.    The patient's past medical history included Retinal tear (patient had a history of retinal tear in the left eye that was treated with laser barricade few years back.), Ovarian cyst and Hysterectomy (Patient had a remote history of hysterectomy more than 25 years ago for ovarian cysts.). Concurrent medical conditions included Myopia (patient is a myope) and Hypercholesterolemia. Concomitant products included SIMVASTATIN, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and VITAMIN D [VITAMIN D NOS] for Hypercholesterolemia.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and dose of INFLUENZA VACCINE (INFLUENZA VIRUS VACCINE) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RETINAL WHITE DOTS SYNDROME (Multiple evanescent white dot syndrome) (seriousness criterion medically significant), COVID-19 (COVID-19) (seriousness criterion hospitalization), MALAISE (mild malaise) and VACCINATION SITE PAIN (soreness at the site of injection). At the time of the report, RETINAL WHITE DOTS SYNDROME (Multiple evanescent white dot syndrome) was resolving, COVID-19 (COVID-19) outcome was unknown and MALAISE (mild malaise) and VACCINATION SITE PAIN (soreness at the site of injection) had resolved. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: Unremarkable. On an unknown date, Fluorescence angiogram: Fluorescein angiography image of left eye at presentation was showing hyper-fluorescence of the retinal lesions with many showing a characteristic wreath pattern and Fluorescein angiography image of left eye 6 weeks following presentation showing nonspecific patchy fluorescence consistent with the resolution and evolution of the outer retinal lesions. On an unknown date, Fundoscopy: Dilated fundus exam of the left eye was significant for multiple faint outer retinal lesions in the peripapillary and peri-macular areas and extending to the periphery that were white-yellow in color. It was also noted for posterior vitreous detachments with evidence of myopic degeneration in both eyes and laser scars surrounding retinal hole in the left eye. and left eye at 6 weeks following presentation showing the continued resolution and evolution of the outer retinal lesions.. On an unknown date, Fundus autofluorescence: The outer retinal lesions seen on exam in the left eye demonstrated hyperautofluorescence on fundus autofluorescence (FAF) imaging (FAF image of left eye at baseline about 10 months prior to presentation. and FAF image of left eye 6 weeks following presentation was showing the continued resolution of previously seen lesions with the appearance of additional new lesions on the temporal macula. On an unknown date, Ophthalmological examination: vision was 20/25 in the right eye and 20/30 in the left eye with normal pressures in both eyes. No cells or flare were seen in either the anterior chamber or vitreous in both eye.. On an unknown date, Optical coherence tomography: Spectral domain-optical coherence tomography (SD-OCT) scans showed multiple small subretinal hyper-reflective lesions in the macula that were more concentrated nasally with disruption of the ellipsoid zone (EZ) (SD-OCT scan through the macula of left eye at baseline about 8 months prior to presentation. and SD-OCT scan 6 weeks following presentation showing continued resolution of the subretinal hyper-reflective material and the restoration of the ellipsoid zone. On an unknown date, Retinogram: Full-field electroretinogram showed mildly depressed response of the left eye with significant asymmetry between the two eyes. On an unknown date, SARS-CoV-2 test: (Positive) approximately 4 months prior to presentation. On an unknown date, Visual field tests: Humphrey visual field (HVF) 30-2 of left eye at presentation was showing enlarged blind spot and HVF 30-2 of left eye 8 weeks following presentation was showing resolution of the enlarged blind spot.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RETINAL WHITE DOTS SYNDROME (Multiple evanescent white dot syndrome), COVID-19 (COVID-19), MALAISE (mild malaise) and VACCINATION SITE PAIN (soreness at the site of injection) to be related.    It was reported that patient had symptoms of pulsating light in her left eye and mild blurriness of her vision in that eye as well as noticeable darkening of the left peripheral field of vision. The symptoms started 4 days prior to presentation to clinic and only 3 days following administration of mRNA-1273 booster vaccine. Systemic workup to rule out autoimmune and infectious etiologies came back negative. Patient was administered 1st and 2nd mRNA-1273 vaccine doses 8 months prior to presentation of clinic and influenza vaccine administered 31 days prior to presentation of clinic. No treatment medication was reported.  Company Comment: This literature case concerns a 71-year-old, myopic female patient with a history of retinal tear in the left eye that was treated with laser barricade, who experienced an unexpected, medically significant event of Retinal white dots syndrome and an unexpected, serious AESI COVID-19 in association with mRNA-1273 vaccine. Event COVID-19 occurred 4 months before the patient received a booster dose of mRNA-1272 vaccine. She was briefly hospitalized due to anosmia and ageusia after testing positive for COVID-19 on an unknown date. After her booster vaccination on an unknown date, she developed mild malaise and injection site soreness that lasted for 1 day. A new and sudden onset of "pulsating light" in her left eye briefly occurred 3 days post-vaccination. Immediately after, mild blurring of vision in the same eye with noticeable darkening of the left peripheral field of vision occurred. The next day, she sought consult and was assessed with a provisional diagnosis of Multiple evanescent white dot syndrome (MEWDS). On exam, vision was 20/25 in the right eye and 20/30 in the left eye with normal eye pressures in both eyes. No cells or flare were seen in either the anterior chamber or vitreous in both eyes. Dilated fundus exam of the left eye showed significant multiple faint white-yellow outer retinal lesions more concentrated around the nerve and the peri-macular area but also extending to the mid-periphery. Posterior vitreous detachments with evidence of myopic degeneration in both eyes and laser scars surrounding the retinal hole in the left eye were also noted on dilated fundus exam. Fundus auto fluorescence revealed hyper-auto fluorescence of outer retinal lesions in the left eye. Spectral domain-optical coherence tomography scans showed multiple small sub retinal hyper-reflective lesions in the macula that were more concentrated nasally with disruption of the ellipsoid zone. Fluorescein angiography of the left eye showed hyper-fluorescence of the retinal lesions with many showing a characteristic wreath pattern. Unspecified systemic workup to rule out autoimmune and infectious etiologies were negative and chest radiograph was unremarkable. A full-field electroretinogram of the left eye showed mildly depressed response. Symptoms of MEWDS spontaneously resolved after 6 weeks from the onset of the event as supported by improvements seen in the repeat imaging. At about 8 weeks after the onset, Humphrey visual field 30-2 of the left eye showed resolution of the previously noted enlarged blind spot. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine 8 months prior to the onset of MEWDS and influenza vaccine  a confounder to MEWDS - 31 days before event onset. Despite the notable temporal association, establishing causality of the event MEWDS with mRNA-1273 vaccination remains a challenge due to poorly understood pathophysiology of MEWDS and development of ocular events post vaccination in general per the authors. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness per medical judgement.  Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2022: Live follow-up received by safety on 11-Aug-2022 has email with full text article received and contains significant information: Reporter information, literature information, medical history, laboratory data, treatment drugs and event information were updated.; Sender's Comments: This literature case concerns a 71-year-old, myopic female patient with a history of retinal tear in the left eye that was treated with laser barricade, who experienced an unexpected, medically significant event of Retinal white dots syndrome and an unexpected, serious AESI COVID-19 in association with mRNA-1273 vaccine. Event COVID-19 occurred 4 months before the patient received a booster dose of mRNA-1272 vaccine. She was briefly hospitalized due to anosmia and ageusia after testing positive for COVID-19 on an unknown date. After her booster vaccination on an unknown date, she developed mild malaise and injection site soreness that lasted for 1 day. A new and sudden onset of "pulsating light" in her left eye briefly occurred 3 days post-vaccination. Immediately after, mild blurring of vision in the same eye with noticeable darkening of the left peripheral field of vision occurred. The next day, she sought consult and was assessed with a provisional diagnosis of Multiple evanescent white dot syndrome (MEWDS). On exam, vision was 20/25 in the right eye and 20/30 in the left eye with normal eye pressures in both eyes. No cells or flare were seen in either the anterior chamber or vitreous in both eyes. Dilated fundus exam of the left eye showed significant multiple faint white-yellow outer retinal lesions more concentrated around the nerve and the peri-macular area but also extending to the mid-periphery. Posterior vitreous detachments with evidence of myopic degeneration in both eyes and laser scars surrounding the retinal hole in the left eye were also noted on dilated fundus exam. Fundus auto fluorescence revealed hyper-auto fluorescence of outer retinal lesions in the left eye. Spectral domain-optical coherence tomography scans showed multiple small sub retinal hyper-reflective lesions in the macula that were more concentrated nasally with disruption of the ellipsoid zone. Fluorescein angiography of the left eye showed hyper-fluorescence of the retinal lesions with many showing a characteristic wreath pattern. Unspecified systemic workup to rule out autoimmune and infectious etiologies were negative and chest radiograph was unremarkable. A full-field electroretinogram of the left eye showed mildly depressed response. Symptoms of MEWDS spontaneously resolved after 6 weeks from the onset of the event as supported by improvements seen in the repeat imaging. At about 8 weeks after the onset, Humphrey visual field 30-2 of the left eye showed resolution of the previously noted enlarged blind spot. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine 8 months prior to the onset of MEWDS and influenza vaccine  a confounder to MEWDS - 31 days before event onset. Despite the notable temporal association, establishing causality of the event MEWDS with mRNA-1273 vaccination remains a challenge due to poorly understood pathophysiology of MEWDS and development of ocular events post vaccination in general per the authors. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness per medical judgement.