Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Computerised tomogram, Depression, Inappropriate schedule of product administration, Post procedural complication
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis/Stiffness every morning through out whole body) in a 60-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 Psoriatic arthritis. Concurrent medical conditions included Psoriatic arthritis. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-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 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 01-Jan-2021, 2nd dose on 01-Feb-2021 and booster dose on 01-Mar-2021). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis/Stiffness every morning through out whole body) (seriousness criterion medically significant), ULCER (Ulcer), DEPRESSION (Depression/felt depressed), ANXIETY (felt anxious), POST PROCEDURAL COMPLICATION (Pee coming through stomach after surgery) and PYREXIA (Fever). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis/Stiffness every morning through out whole body), ANXIETY (felt anxious) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 01-Jan-2021, 2nd dose on 01-Feb-2021 and booster dose on 01-Mar-2021) outcome was unknown, ULCER (Ulcer), DEPRESSION (Depression/felt depressed) and PYREXIA (Fever) had not resolved and POST PROCEDURAL COMPLICATION (Pee coming through stomach after surgery) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: ulcer. No concomitant medications were reported. The patient had multiple surgeries due to rheumatoid arthritis. Patient also had fever due to taking some other medications. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event(s) of rheumatoid arthritis, ulcer, depression/felt depressed and fever with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of pee coming through stomach after surgery with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of stiffness every morning throughout whole body was not provided. Regulatory Authority opinion was that there was no reasonable possibility that the events of rheumatoid arthritis, pee coming through stomach after surgery and stiffness every morning throughout whole body are related to Humira(adalimumab). Regulatory Authority opinion was that the events of ulcer, depression/felt depressed and fever were not assessable. No treatment medications were reported. Company comment: This spontaneous case concerns 60 years old female patient, with no relevant medical history, who experienced unexpected Serious (medically significant) AESI event of rheumatoid arthritis, which occurred unspecified days after third dose of mRNA-1273 vaccine. Additionally non serious event pyrexia is also reported. Patient had multiple surgeries due to rheumatoid arthritis, patient also felt anxious as well, patient was taking some other medication. Inappropriate schedule of product administration is also reported. At the time of reporting outcome of the event is unknown. Elderly age is confounding for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns 60 years old female patient, with no relevant medical history, who experienced unexpected Serious (medically significant) AESI event of rheumatoid arthritis, which occurred unspecified days after third dose of mRNA-1273 vaccine. Additionally non serious event pyrexia is also reported. Patient had multiple surgeries due to rheumatoid arthritis, patient also felt anxious as well, patient was taking some other medication. Inappropriate schedule of product administration is also reported. At the time of reporting outcome of the event is unknown. Elderly age is confounding for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.