Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, Palpitations, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis; Heart palpitations; Interchange of vaccine products; Covid-19 immunization; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in an adult 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 COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination, ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    No Medical History information was reported.   In July 2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In June 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received second dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and METHOTREXATE (unknown route) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Covid-19 immunization). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis) and PALPITATIONS (Heart palpitations) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Covid-19 immunization) outcome was unknown.            Concomitant medication not reported.  Treatment medication not reported.  The reporter's causality for the event of Rheumatoid Arthritis and heart palpitations with Adalimumab Solution for Injection was No Reasonable Possible.  The reporter's causality for the event of Rheumatoid Arthritis with Methotrexate was Not Provided and for event heart palpitation was reasonable Possible.  The reporter's causality for the event of heart palpitations with Janssen COVID-19 vaccine was Not Provided and for event Rheumatoid Arthritis it was reasonable possible.  Company Comment: This is a spontaneous case concerning  an  adult female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Rheumatoid arthritis, and unexpected non-serious events of Palpitations. The exact date of administration of third dose of mRNA-1273 and onset of the events was not specified, hence latency could not be assessed. It was also reported that patient received 1st and 2nd dose Jansen Covid-19 Vaccine. Covid-19 immunisation and Interchange of vaccine are additional events. No further details on clinical course, lab test results and treatment received were reported. The events were reported as resolving The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  an  adult female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Rheumatoid arthritis, and unexpected non-serious events of Palpitations. The exact date of administration of third dose of mRNA-1273 and onset of the events was not specified, hence latency could not be assessed. It was also reported that patient received 1st and 2nd dose Jansen Covid-19 Vaccine. Covid-19 immunisation and Interchange of vaccine are additional events. No further details on clinical course, lab test results and treatment received were reported. The events were reported as resolving The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.