Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Osteoarthritis, Pain, Pain in extremity, Rheumatoid arthritis, Swelling
Clinical narrative: Hemorrhoids; Stomach cramps; Osteoarthritis; Pain; Diarrhea; Tiredness; Rheumatoid arthritis; Swelling; Hand pain; CARPAL TUNNEL OF BOTH HANDS; This spontaneous case was reported by a health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) 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 Crohn's disease.    The patient's past medical history included Hip discomfort in 2019 and Alcohol use in 1959. Concomitant products included BUDESONIDE (ENTOCORT) for Crohn's disease, VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2020, the patient experienced CARPAL TUNNEL SYNDROME (CARPAL TUNNEL OF BOTH HANDS). In February 2021, the patient experienced SWELLING (Swelling). On 12-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant). In April 2021, the patient experienced FATIGUE (Tiredness). In 2021, the patient experienced PAIN IN EXTREMITY (Hand pain). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), HAEMORRHOIDS (Hemorrhoids), ABDOMINAL PAIN UPPER (Stomach cramps), OSTEOARTHRITIS (Osteoarthritis) and PAIN (Pain). The patient was treated with COLESTIPOL at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis), CARPAL TUNNEL SYNDROME (CARPAL TUNNEL OF BOTH HANDS), ABDOMINAL PAIN UPPER (Stomach cramps), SWELLING (Swelling), PAIN IN EXTREMITY (Hand pain) and FATIGUE (Tiredness) had not resolved, DIARRHOEA (Diarrhea) and HAEMORRHOIDS (Hemorrhoids) was resolving and OSTEOARTHRITIS (Osteoarthritis) and PAIN (Pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the event swelling was prior to 1st dose of vaccine administration and it is unlikely related to vaccine. Humira may remain as risk factor.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the event swelling was prior to 1st dose of vaccine administration and it is unlikely related to vaccine. Humira may remain as risk factor.