Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Eye irritation, Glaucoma, Immunisation reaction, Retinal tear
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GLAUCOMA (Glaucoma) and RETINAL TEAR (Tear in retina) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis. Concurrent medical conditions included Psoriatic arthritis. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2020, the patient experienced COVID-19 (COVID-19). In 2021, the patient experienced IMMUNISATION REACTION (Severe reaction to Covid vaccine). In March 2022, the patient experienced GLAUCOMA (Glaucoma) (seriousness criterion medically significant). On 27-Aug-2022, the patient experienced RETINAL TEAR (Tear in retina) (seriousness criterion medically significant). On an unknown date, the patient experienced EYE IRRITATION (Eye feels like on fire). At the time of the report, GLAUCOMA (Glaucoma) was resolving and RETINAL TEAR (Tear in retina), EYE IRRITATION (Eye feels like on fire), IMMUNISATION REACTION (Severe reaction to Covid vaccine) and COVID-19 (COVID-19) outcome was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Humira causality for the event of glaucoma was no reasonable possibility and for event of tear in retina, eye feels like on fire, severe reaction to Covid vaccine and Covid was not provided. No concomitant medication information was reported. No treatment medication information was reported. Company comment- This spontaneous case concerns a 64-year-old male patient with relevant medical condition of psoriatic arthritis treated with Adalimumab (reported as co-suspect), who experienced the unexpected serious (medically significant) events of glaucoma and retinal tear along with the non-serious unexpected AESI COVID-19. Three doses of mRNA-1273 vaccine were administered. Latency unknown as vaccination date was not specified. The event COVID-19 occurred before vaccination took place and the outcome was reported as unknown. Patient had an eye surgery for glaucoma and was healing from complications. He then had tear in his retina which was fix with laser surgery. Laser surgery was painful, eye felt like on fire. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 64-year-old male patient with relevant medical condition of psoriatic arthritis treated with Adalimumab (reported as co-suspect), who experienced the unexpected serious (medically significant) events of glaucoma and retinal tear along with the non-serious unexpected AESI COVID-19. Three doses of mRNA-1273 vaccine were administered. Latency unknown as vaccination date was not specified. The event COVID-19 occurred before vaccination took place and the outcome was reported as unknown. Patient had an eye surgery for glaucoma and was healing from complications. He then had tear in his retina which was fix with laser surgery. Laser surgery was painful, eye felt like on fire. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.