Age: 58.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Blood test, Central vision loss, Ophthalmological examination, Retinal haemorrhage
Clinical narrative: They would probably call it a serious retina, central vision problem; the blood vessel let loose and the blood went under the retina; This spontaneous case was reported by a patient and describes the occurrence of CENTRAL VISION LOSS (They would probably call it a serious retina, central vision problem) and RETINAL HAEMORRHAGE (the blood vessel let loose and the blood went under the retina) in a 58-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    Concomitant products included VITAMINS NOS for an unknown indication.   On 10-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) 1 dosage form. On 19-Nov-2023, the patient experienced CENTRAL VISION LOSS (They would probably call it a serious retina, central vision problem) (seriousness criterion medically significant) and RETINAL HAEMORRHAGE (the blood vessel let loose and the blood went under the retina) (seriousness criterion medically significant). At the time of the report, CENTRAL VISION LOSS (They would probably call it a serious retina, central vision problem) had not resolved and RETINAL HAEMORRHAGE (the blood vessel let loose and the blood went under the retina) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2023, Ophthalmological examination: He had a distorted retina, and a bulging retina, A blood vessel that was swollen behind the retina was creating pressure on the retina and the blood vessel let loose and the blood went under the retina. They would probably call it a serious retina, central vision problem.. On an unknown date, Blood test: Inconclusive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered CENTRAL VISION LOSS (They would probably call it a serious retina, central vision problem) to be related. No further causality assessment was provided for RETINAL HAEMORRHAGE (the blood vessel let loose and the blood went under the retina).    Patient had no known allergies. otherwise, healthy, no daily medications other than vitamins.  Patient receives other vaccine in the 4 weeks prior to COVID-19 vaccine.  Suspect vaccine dosage text was unknown.  After 40 to 42 days after receiving the vaccine his left eye went hay wire and he started to had a fun house mirror effect. On 19-Nov-2023 his eye began to bother him but on the 20-Nov-2023 it got worse. On 21-Nov-2023 an imaging was done to the back of the eye. He had a distorted retina, and a bulging retina, A blood vessel that was swollen behind the retina was creating pressure on the retina and the blood vessel let loose and the blood went under the retina. They would probably call it a serious retina, central vision problem. At the time of reporting patient was under treatment receiving shots (type of anti-inflammatory) in the eye to stabilize his eye. He was unsure of how many more treatments he would require, and if he would need them for the rest of his life. Patient was almost certain it causes due to Moderna shot.  Patient stated that When you get a COVID shot the spike proteins circulate in your blood system or artery or capillary and it could cause damage to your endothelial cells, which creates a reaction at the molecular level. The angiopoietin-2 growth factor damages blood vessels which becomes more permeable and causes inflammation of blood systems. He believe this was what caused the leakage of blood behind his retina.  Patient had a follow-up appointment on 14-Feb-2024.  Company comment: This spontaneous case concerns a 58-year-old, male patient with no medical history information reported, who experienced the unexpected serious (medically significant) events of central vision loss and retinal hemorrhage. The events occurred approximately 40-42 days after the sixth dose of Spikevax 2023-2024. As reported, 40 to 42 days after receiving the vaccine patient's left eye went hay wire and he started to had a fun house mirror effect. Forty days after 6th dose his eye began to bother him getting worse on the next day. forty two days after 6th dose an imaging was done to the back of the eye and patient had a distorted retina, and a bulging retina, a blood vessel that was swollen behind the retina was creating pressure on the retina and the blood vessel let loose and the blood went under the retina, as reported. Patient stated they would probably call it a serious retina, central vision problem. At the time of reporting patient was under treatment receiving shots (type of anti-inflammatory) in the eye to stabilize his eye. The benefit-risk relationship of Spikevax 2023-2024 is not affected by this report.   This case was linked to MOD-2021-396164 (Patient Link).