Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pain, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Insomnia; Body ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a female patient of an unknown age 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) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe Rheumatoid Arthritis ).   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), INSOMNIA (Insomnia), PAIN (Body ache) and CHILLS (Chills). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved and INSOMNIA (Insomnia), PAIN (Body ache) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided by the reporter. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Treatment information was not provided.  The reporter's causality for the event(s) of Rheumatoid Arthritis flare up, body aches, insomnia  and chills  with Adalimumab Solution for Injection was Reasonable Possibility.  Company Comment:  This spontaneous case concerns a female patient of an unknown age with concurrent Rheumatoid arthritis on Adalimumab, who experienced the unexpected, serious  (medically significant) adverse event of special interest Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) in the context of receiving the third dose of mRNA-1273 vaccine.  Onset latency could not be assessed as the event start date was not given.  Outcome of the event was not resolved at the time of report. Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart, with the 2nd dose administered approximately 9 and a half months prior to current vaccine. The concurrent Rheumatoid arthritis remains a confounder as it is a chronic, progressive disease that is known to present with flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age with concurrent Rheumatoid arthritis on Adalimumab, who experienced the unexpected, serious  (medically significant) adverse event of special interest Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) in the context of receiving the third dose of mRNA-1273 vaccine.  Onset latency could not be assessed as the event start date was not given.  Outcome of the event was not resolved at the time of report. Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart, with the 2nd dose administered approximately 9 and a half months prior to current vaccine. The concurrent Rheumatoid arthritis remains a confounder as it is a chronic, progressive disease that is known to present with flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.