Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chalazion, Cystoid macular oedema, Eosinophil count, Eosinophil percentage, Eye inflammation
Clinical narrative: eye inflammation; Vision lost in left eye; Panuveitis; Cystoid macular edema; Central blurring of the vision /  central blurring is worsened; developed chalazion in eye; Stye in the left eye; redness in the eye; redness in the eye, pain and swelling; redness in the eye, pain and swelling; This spontaneous case was reported by a physician and describes the occurrence of BLINDNESS UNILATERAL (Vision lost in left eye), UVEITIS (Panuveitis) and CYSTOID MACULAR OEDEMA (Cystoid macular edema) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced OCULAR HYPERAEMIA (redness in the eye), EYE PAIN (redness in the eye, pain and swelling) and EYE SWELLING (redness in the eye, pain and swelling). On 21-Apr-2021, the patient experienced HORDEOLUM (Stye in the left eye). On 10-May-2021, the patient experienced CHALAZION (developed chalazion in eye). On 29-May-2021, the patient experienced VISION BLURRED (Central blurring of the vision /  central blurring is worsened). On 04-Jun-2021, the patient experienced BLINDNESS UNILATERAL (Vision lost in left eye) (seriousness criterion medically significant), UVEITIS (Panuveitis) (seriousness criterion medically significant) and CYSTOID MACULAR OEDEMA (Cystoid macular edema) (seriousness criterion medically significant). On an unknown date, the patient experienced EYE INFLAMMATION (eye inflammation). The patient was treated with DEXAMETHASONE, TOBRAMYCIN (TOBRADEX) on 03-May-2021 for Stye, at a dose of UNK UNK, tid; DEXAMETHASONE, TOBRAMYCIN (TOBRADEX) from 21-Apr-2021 to 30-May-2021 for Stye, at a dose of UNK UNK, qid; DOXYCYCLINE on 03-May-2021 for Eye discharge, at a dose of UNK dosage form and BROMFENAC SODIUM (PROLENSA) on 08-Jun-2021 for Eye inflammation, at a dose of UNK dosage form. On 28-Apr-2021, OCULAR HYPERAEMIA (redness in the eye) and EYE SWELLING (redness in the eye, pain and swelling) had resolved. At the time of the report, BLINDNESS UNILATERAL (Vision lost in left eye), UVEITIS (Panuveitis), CYSTOID MACULAR OEDEMA (Cystoid macular edema), HORDEOLUM (Stye in the left eye), CHALAZION (developed chalazion in eye), EYE PAIN (redness in the eye, pain and swelling) and EYE INFLAMMATION (eye inflammation) outcome was unknown and VISION BLURRED (Central blurring of the vision /  central blurring is worsened) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jun-2021, Alanine aminotransferase: 22 (normal) 22 IU/L Normal range: 0-44 IU/L. On 08-Jun-2021, Albumin globulin ratio: 2.2 (normal) 2.2 Normal range: 1.2-2.2. On 08-Jun-2021, Angiotensin converting enzyme (14-82): 55 (normal) 55 U/L Normal range: 14-82 U/L. On 08-Jun-2021, Aspartate aminotransferase (0-40): 22 (normal) 22 IU/L. On 08-Jun-2021, Basophil count (0.0-0.2): 0.1 (normal) 0.1 x10E3/ uL. On 08-Jun-2021, Basophil percentage: 1 (normal) 1 percent. On 08-Jun-2021, Blood albumin (3.8-4.9): 4.6 (normal) 4.6 g/dL. On 08-Jun-2021, Blood alkaline phosphatase (48-121): 82 (normal) 82 IU/L. On 08-Jun-2021, Blood bilirubin (0.0-1.2): 0.4 (normal) 0.4 mg/dL. On 08-Jun-2021, Blood calcium (8.7-10.2): 9.6 (normal) 9.6 mg/dL. On 08-Jun-2021, Blood chloride (96-106): 102 (normal) 102 mmol/L. On 08-Jun-2021, Blood creatinine (0.76-1.27): 0.87 (normal) 0.87 mg/dL. On 08-Jun-2021, Blood glucose (65-99): 98 (normal) 98 milligram per deciliter. On 08-Jun-2021, Blood potassium (3.5-5.2): 4.0 (normal) 4.0 mmol/L. On 08-Jun-2021, Blood sodium (134-144): 141 (normal) 141 mmol/L. On 08-Jun-2021, Blood urea (6-24): 11 (normal) 11 mg/ dL. On 08-Jun-2021, Blood urea nitrogen/creatinine ratio (9-20): 13 (normal) 13. On 08-Jun-2021, C-reactive protein (0-10): 2 (normal) 2 mg/L. On 08-Jun-2021, Carbon dioxide (20-29): 25 (normal) 25 mmol/L. On 08-Jun-2021, Eosinophil count (0,0-0.4): 0.1 (normal) 0.1 x10E3/uL. On 08-Jun-2021, Eosinophil percentage: 1 (Inconclusive) 1 percent. On 08-Jun-2021, Globulin (1.5-4.5): 2.1 (normal) 2.1 g/dL. On 08-Jun-2021, Glomerular filtration rate (Unknown->59): 99 (normal) 99 mL/min/1.73. On 08-Jun-2021, HIV test: negative (Negative) Non-reactive. On 08-Jun-2021, Haematocrit (37.5-51.0): 47.5 (normal) 47.5 percent. On 08-Jun-2021, Haemoglobin (13.0-17.7): 15.1 (normal) 15.1 gram per deciliter. On 08-Jun-2021, Immature granulocyte count (0.0-0.1): 0.0 (normal) 0.0 x10E3 u/L absolute count 0 percentage. On 08-Jun-2021, Lymphocyte count (0.7-3.1): 1.6 (normal) 1.6 x10E3/ uL absolute count. On 08-Jun-2021, Lymphocyte percentage: 28 (Inconclusive) 28 percent. On 08-Jun-2021, Lysozyme (3.0-12.8): 5.0 (normal) 5.0 ug/mL. On 08-Jun-2021, Mean cell haemoglobin (26.6-33.0): 27.2 (normal) 27.2 pg. On 08-Jun-2021, Mean cell haemoglobin concentration (31.5-35.7): 31.8 (normal) 31.8 g/dL. On 08-Jun-2021, Mean cell volume (79-97): 86 (normal) 86 fL. On 08-Jun-2021, Monocyte count (0.1-0.9): 0.5 (normal) 0.5 x10E3/ uL. On 08-Jun-2021, Monocyte percentage: 8 (Inconclusive) 8 percent. On 08-Jun-2021, Neutrophil count (1.4-7.0): 3.6 (normal) 3.6 x 10E3/ uL absolute count. On 08-Jun-2021, Neutrophil percentage: 62 (Inconclusive) 62 percent. On 08-Jun-2021, Platelet count (150-450): 339 (normal) 339 x10E3/ uL. On 08-Jun-2021, Protein total (6.0-8.5): 6.7 (normal) 6.7 g/dL. On 08-Jun-2021, Red blood cell count (4.14-5.80): 5.55 (normal) 5.55 x10E6/uL. On 08-Jun-2021, Red blood cell sedimentation rate (0-30): 2 (normal) 2 mm/hr. On 08-Jun-2021, Red cell distribution width (11.6-15.4): 13.1 (normal) 13.1 percent. On 08-Jun-2021, Rheumatoid factor (0.0-13.9): <10.0 (normal) <10.0 IU/mL. On 08-Jun-2021, Toxoplasma serology: negative (Negative) No serological evidence of infection with toxoplasma IgG antibodies <3.0 IgM antibodies <3.0. On 08-Jun-2021, Treponema test: negative (Negative) Non reactive and negative (Negative) T pallidum Ab (FTA-Ab) non-reactive. On 08-Jun-2021, White blood cell count (3.4-10.8): 5.9 (normal) 5.9 x10E3/uL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 19-Apr-2021, the patient who was a physician started having problem related to the eye. On 21Apr2021, he was seen by an eye specialist, and was diagnosed with Stye in the left eye.  on 28Apr2021, he had a second visit with the eye specialist. He reported that he stopped using Tobradex on an unspecified date, and had a relapse of eye problems as earlier.  On 3May2021, he consulted an eye specialist and was asked to continue the same prescription. On 10-May2021 he felt better but developed chalazion in eye, and continued the antibiotic. From 29-May2021, he started experiencing central blurring of the vision.  On 2-Jun2021, he consulted the ophthalmologist, OCT (Optical Coherence Tomography) was performed to check retina. He was advised to consult a retina specialist. On 4-Jun-2021, he saw a retina specialist.  retino-angiogram, OCT test, tumor markers, quantiferon TB gold test, HLA B27 test, Lyme's total antibody tests were performed. Diagnosis given included pan uveitis, cystoid macular edema, eyeball  immuno-privileged, vision lost in left eye and central blurring in left eye. On 8-Jun-2021, he visited retina specialist. An OCT test was done. Central blurring was worsened. The patient had an upcoming appointment with the retina specialist on 11Jun2021 and 15Jun2021. He mentioned that it was very difficult to work on computer with blurry vision from left eye and he could not work for more that 10-15 minutes.  Concomitant medications were not reported.  Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up included no new information. On 09-Jun-2021: Follow up was significant included 2 attachments; 1. snapshot of OCT  2. lab investigation details. On 10-Jun-2021: Medically Significant removed as seriousness criteria for event Blurring of vision.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.