Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cataract, Inappropriate schedule of product administration, Post-acute COVID-19 syndrome, Vaccination failure
Clinical narrative: Cataract; vaccination failure; Long Covid; Patient received dose 2 on 05-Mar-2021 and booster dose on 31-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (Cataract) in a 72-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 (Moderate to Severe Rheumatoid Arthritis).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-May-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. On 31-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 2 on 05-Mar-2021 and booster dose on 31-May-2021). In December 2021, the patient experienced POST-ACUTE COVID-19 SYNDROME (Long Covid). On an unknown date, the patient experienced CATARACT (Cataract) (seriousness criterion medically significant) and VACCINATION FAILURE (vaccination failure). At the time of the report, CATARACT (Cataract), POST-ACUTE COVID-19 SYNDROME (Long Covid), VACCINATION FAILURE (vaccination failure) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 2 on 05-Mar-2021 and booster dose on 31-May-2021) outcome was unknown.            No concomitant medications were reported.  Co-suspect Humira formulation was reported as solution for injection and dose details was reported as single dose pen.  The reporter's causality for the events of cataract and long Covid with Humira was not provided.  It was unknown if patient was enrolled in COVID-19-Vaccine trial or not.  The MPID was reported as 4782591.  No treatment information was reported.  Company comment- This spontaneous case concerns a 72-year-old female patient with no relevant medical history, who experienced unexpected, serious (medically significant) event of Cataract, which occurred at an unknown time with regards to vaccination with a booster dose of mRNA-1273. Vaccination failure was also reported in the case since the interval between the first and second doses of mRNA was noted to be 35 days. Inappropriate schedule of product administration was also noted as an event since the interval between the second dose and the booster dose is 2 months and 26 days. No further information was provided. The outcome of the event was reported as unknown. The advanced age of the patient is a risk factor for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 72-year-old female patient with no relevant medical history, who experienced unexpected, serious (medically significant) event of Cataract, which occurred at an unknown time with regards to vaccination with a booster dose of mRNA-1273. Vaccination failure was also reported in the case since the interval between the first and second doses of mRNA was noted to be 35 days. Inappropriate schedule of product administration was also noted as an event since the interval between the second dose and the booster dose is 2 months and 26 days. No further information was provided. The outcome of the event was reported as unknown. The advanced age of the patient is a risk factor for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.