Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Rheumatoid arthritis
Clinical narrative: extreme flare up of her rheumatoid arthritis -every joint was swollen; arthritis reumathoid aggravated; Every joint was swollen; not feeling good; dizzy; diarrhea; headache; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (extreme flare up of her rheumatoid arthritis -every joint was swollen) and CONDITION AGGRAVATED (arthritis reumathoid aggravated) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Rheumatoid arthritis and Hashimoto's disease.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced DIZZINESS (dizzy), DIARRHOEA (diarrhea), HEADACHE (headache) and NAUSEA (nauseated). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (extreme flare up of her rheumatoid arthritis -every joint was swollen) (seriousness criteria disability and medically significant), CONDITION AGGRAVATED (arthritis reumathoid aggravated) (seriousness criterion disability), JOINT SWELLING (Every joint was swollen) and MALAISE (not feeling good). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency; ADALIMUMAB (HUMIRA) at an unspecified dose and frequency and ETANERCEPT (ENBREL) at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (extreme flare up of her rheumatoid arthritis -every joint was swollen), CONDITION AGGRAVATED (arthritis reumathoid aggravated), JOINT SWELLING (Every joint was swollen), MALAISE (not feeling good), DIZZINESS (dizzy), DIARRHOEA (diarrhea), HEADACHE (headache) and NAUSEA (nauseated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication listed.  No treatment information provided.  Company Comment : This case concerns a 47  year-old, female subject,  with clinical history of Thyroidectomy, and Concurrent medical conditions included Rheumatoid arthritis and Hashimoto's  disease, who experienced the unexpected events of RHEUMATOID ARTHRITIS, JOINT SWELLING, CONDITION AGGRAVATED of her disease and other non-serious events. The events occurred unknown days after the second dose of [Spikevax]  The rechallenge is negative (We know that these serious adverse events did not occur after first dose.) The medical history of Arthritis Reumathoid remains a confounder. The benefit-risk relationship of the vaccine is not affected by this report   This case was linked to MOD-2021-336699, MOD-2021-336828 (Patient Link).; Sender's Comments: This case concerns a 47  year-old, female subject,  with clinical history of Thyroidectomy, and Concurrent medical conditions included Rheumatoid arthritis and Hashimoto's  disease, who experienced the unexpected events of RHEUMATOID ARTHRITIS, JOINT SWELLING, CONDITION AGGRAVATED of her disease and other non-serious events. The events occurred unknown days after the second dose of [Spikevax]  The rechallenge is negative (We know that these serious adverse events did not occur after first dose.) The medical history of Arthritis Reumathoid remains a confounder. The benefit-risk relationship of the vaccine is not affected by this report