Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Erythema, Glaucoma, Inappropriate schedule of product administration, Joint swelling
Clinical narrative: Glaucoma/ Dry eye syndrome; bad varicose veins; COVID-19; Hurt every time when moved, like someone beat with a bat; Joints swelled and turned red; Joints swelled and turned red; Moderna first dose on 28-Sep-2021 and second dose on 15-Oct-2021; This spontaneous case was reported by a patient and describes the occurrence of GLAUCOMA (Glaucoma/ Dry eye syndrome) in a 64-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, received second 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) 40 milligram. On 15-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna first dose on 28-Sep-2021 and second dose on 15-Oct-2021). On an unknown date, the patient experienced GLAUCOMA (Glaucoma/ Dry eye syndrome) (seriousness criterion medically significant), VARICOSE VEIN (bad varicose veins), COVID-19 (COVID-19), PAIN (Hurt every time when moved, like someone beat with a bat), ERYTHEMA (Joints swelled and turned red) and JOINT SWELLING (Joints swelled and turned red). At the time of the report, GLAUCOMA (Glaucoma/ Dry eye syndrome), VARICOSE VEIN (bad varicose veins), PAIN (Hurt every time when moved, like someone beat with a bat), ERYTHEMA (Joints swelled and turned red), JOINT SWELLING (Joints swelled and turned red) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna first dose on 28-Sep-2021 and second dose on 15-Oct-2021) outcome was unknown and COVID-19 (COVID-19) had resolved.            Concomitant product use was not provided by the reporter.   The reporter's causality for the events of hurt every time when moved, like someone beat with a bat, joints swelled and turned red, bad varicose veins, covid, dry eye syndrome, glaucoma with Adalimumab solution for injection was reported as not provided.  The other manufacturer's causality for the event of hurt every time when moved, like someone beat with a bat, joints swelled and turned red, bad varicose veins, covid, dry eye syndrome, glaucoma with Adalimumab solution for injection was reported as not provided.  The assessment results of Humira 40MG/0.4ML by non health care professional (global introspection) for the events dry eye syndrome, varicose veins, glaucoma, COVID-19, pain upon movement, swollen joints, localized erythema was not reported.  Treatment medication was not provided.  Company comment: This spontaneous case concerns a 64 year old female with no relevant medical history who experienced the unexpected, serious (medically significant) event of glaucoma that occurred in the context of receiving a dose of mRNA1273 as second dose in the COVID-19 vaccine series. Exact latency for the event glaucoma cannot be fully established since the onset date was not reported. The patient received the 2 dose primary series of the vaccine at 17 days interval, which is not in alignment with the recommended dosing schedule (inappropriate schedule of vaccine administered). Further details regarding the clinical course and treatment were not provided. The patient's elderly age may be considered as a risk factor for glaucoma. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 64 year old female with no relevant medical history who experienced the unexpected, serious (medically significant) event of glaucoma that occurred in the context of receiving a dose of mRNA1273 as second dose in the COVID-19 vaccine series. Exact latency for the event glaucoma cannot be fully established since the onset date was not reported. The patient received the 2 dose primary series of the vaccine at 17 days interval, which is not in alignment with the recommended dosing schedule (inappropriate schedule of vaccine administered). Further details regarding the clinical course and treatment were not provided. The patient's elderly age may be considered as a risk factor for glaucoma. The benefit-risk relationship of mRNA-1273 is not affected by this report.