Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction, Eye swelling, Feeling abnormal, Feeling cold, Feeling hot
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated), FEELING HOT (Feeling hot), FEELING ABNORMAL (feeling bad), INFLAMMATION (Inflammation) and ARTHRITIS (Arthritis) in a 58-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.     Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, PROMETHAZINE (PHENERGAN [PROMETHAZINE]), AZITHROMYCIN (Z-PAK) and OXYBUTYNIN from an unknown date to 08-Mar-2021 for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2020, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated). On 04-Mar-2021, the patient experienced HYPERSENSITIVITY (Allergy). In March 2021, the patient experienced ARTHRITIS (Arthritis) and PERIPHERAL SWELLING (Swelling of legs). On an unknown date, the patient experienced FEELING HOT (Feeling hot), FEELING ABNORMAL (feeling bad), INFLAMMATION (Inflammation), FEELING COLD (Cold), MUSCLE SPASMS (Cramps of extremities), BACK PAIN (Back pain), INTERVERTEBRAL DISC DISORDER (Discopathy), NECK PAIN (Neck pain), UNEVALUABLE EVENT (Unevaluable event), FUNGAL SKIN INFECTION (Yeast infection of the skin), EYE SWELLING (Eye swelling), PRURITUS (Extremities itchy sensation of), RASH ERYTHEMATOUS (Red rash), ADVERSE DRUG REACTION (Adverse drug reaction), DRUG INTERACTION (Drug interaction), DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (vaccination site pruritus) and NAUSEA (nausea). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated), FEELING ABNORMAL (feeling bad), MUSCLE SPASMS (Cramps of extremities), BACK PAIN (Back pain), HYPERSENSITIVITY (Allergy) and PERIPHERAL SWELLING (Swelling of legs) had not resolved, FEELING HOT (Feeling hot), INFLAMMATION (Inflammation), UNEVALUABLE EVENT (Unevaluable event), ADVERSE DRUG REACTION (Adverse drug reaction), DRUG INTERACTION (Drug interaction), DIARRHOEA (Diarrhea) and NAUSEA (nausea) was resolving, ARTHRITIS (Arthritis), FEELING COLD (Cold), INTERVERTEBRAL DISC DISORDER (Discopathy), NECK PAIN (Neck pain), FUNGAL SKIN INFECTION (Yeast infection of the skin), EYE SWELLING (Eye swelling) and PRURITUS (Extremities itchy sensation of) outcome was unknown and RASH ERYTHEMATOUS (Red rash) and VACCINATION SITE PRURITUS (vaccination site pruritus) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, X-ray: arthritis (abnormal) Arthritis. In 2021, Blood uric acid: unknown (Inconclusive) Unknown. In 2021, Pain assessment: 8 (High) Pain scale: 8.         No concomitant medications reported by investigator   No treatment medications provided by the reporter.  On unknown date Vitamin D test and Blood uric acid test are the lab tests reported by the reporter. Vitamin D test is done to check the gout.  Based on current available information and temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on current available information and temporal association between product use and the start date of the events a causal relationship cannot be excluded.