Age: 61.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK, UNK
Symptoms: Feeling cold, Feeling hot, Fungal skin infection, Glossodynia, Hypersensitivity
Clinical narrative: Sore tongue; Loss of teeth; Drug interaction; Feeling hot; Discopathy; Feeling bad; Yeast infection of the skin; Extremties itchy sensation; Eye swelling; cold; Diarrhea; Cramps of extremities; Back discomfort; Neck pain; red rash; Back arthritis; injection site pruritus; Nauseous; Itchy eyes; Eyes red; Watering eyes; allergy; Swelling of legs; Rheumatoid arthiritis aggravated; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthiritis aggravated) in a 61-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 products included non-company products ADALIMUMAB (HUMIRA) injection, solution for Rheumatoid arthritis, PROMETHAZINE for an unknown indication, OXYBUTYNIN for an unknown indication and AZITHROMYCIN (Z-PAK) for an unknown indication.    The patient's past medical history included Rheumatoid arthritis, Low back pain in 2018 and Hernia repair (and mesh) in 2018.   In 2013, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. In 2019, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram once a week. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose., PROMETHAZINE (Subcutaneous) at an unspecified dose, OXYBUTYNIN (unknown route) at an unspecified dose and AZITHROMYCIN (Z-PAK) (unknown route) at an unspecified dose. In December 2020, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthiritis aggravated) (seriousness criterion medically significant). On 04-Mar-2021, the patient experienced HYPERSENSITIVITY (allergy). In March 2021, the patient experienced PERIPHERAL SWELLING (Swelling of legs). On 19-May-2021, the patient experienced EYE PRURITUS (Itchy eyes), OCULAR HYPERAEMIA (Eyes red) and LACRIMATION INCREASED (Watering eyes). On an unknown date, the patient experienced GLOSSODYNIA (Sore tongue), TOOTH LOSS (Loss of teeth), DRUG INTERACTION (Drug interaction), FEELING HOT (Feeling hot), INTERVERTEBRAL DISC DISORDER (Discopathy), FEELING ABNORMAL (Feeling bad), FUNGAL SKIN INFECTION (Yeast infection of the skin), PRURITUS (Extremties itchy sensation), EYE SWELLING (Eye swelling), FEELING COLD (cold), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps of extremities), MUSCULOSKELETAL DISCOMFORT (Back discomfort), NECK PAIN (Neck pain), RASH ERYTHEMATOUS (red rash), SPONDYLITIS (Back arthritis), VACCINATION SITE PRURITUS (injection site pruritus) and NAUSEA (Nauseous). The patient was treated with HYDROCODONE at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthiritis aggravated), GLOSSODYNIA (Sore tongue), FEELING ABNORMAL (Feeling bad), FUNGAL SKIN INFECTION (Yeast infection of the skin), MUSCLE SPASMS (Cramps of extremities), HYPERSENSITIVITY (allergy), PERIPHERAL SWELLING (Swelling of legs), SPONDYLITIS (Back arthritis), EYE PRURITUS (Itchy eyes), OCULAR HYPERAEMIA (Eyes red) and LACRIMATION INCREASED (Watering eyes) had not resolved, TOOTH LOSS (Loss of teeth), INTERVERTEBRAL DISC DISORDER (Discopathy), PRURITUS (Extremties itchy sensation), EYE SWELLING (Eye swelling), FEELING COLD (cold), MUSCULOSKELETAL DISCOMFORT (Back discomfort), NECK PAIN (Neck pain) and NAUSEA (Nauseous) outcome was unknown, DRUG INTERACTION (Drug interaction), FEELING HOT (Feeling hot) and DIARRHOEA (Diarrhea) was resolving and RASH ERYTHEMATOUS (red rash) and VACCINATION SITE PRURITUS (injection site pruritus) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lab Result: Pain scale: Unknown test date - no results reported Uric acid test: Unknown test date - no results reported Urine test: 27-Apr-2021 - no results reported Vitamin D test: Unknown test date - no results reported X-Ray: ??-Mar-2021 - no results reported  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up 2 information included additional events eye pruritus, ocular hyperaemia, lacrimation increased, and spondylitis. Outcome of events nausea and diarrhea updated to recovering. Outcome of events muscle spasms and fungal skin infection updated to not recovered.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.