Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Hyperhidrosis, Rheumatoid arthritis, Ventricular extrasystoles
Clinical narrative: INCREASED RHEUMATOID ARTHRITIS FLARE UPS; Premature ventricular contractions; DIAPHORESIS with HUMIRA (ADALIMUMAB).; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (INCREASED RHEUMATOID ARTHRITIS FLARE UPS) 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.    Concomitant products included METHOTREXATE for an unknown indication.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (INCREASED RHEUMATOID ARTHRITIS FLARE UPS) (seriousness criterion medically significant), VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions) and HYPERHIDROSIS (DIAPHORESIS with HUMIRA (ADALIMUMAB).). At the time of the report, RHEUMATOID ARTHRITIS (INCREASED RHEUMATOID ARTHRITIS FLARE UPS) had not resolved and VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions) and HYPERHIDROSIS (DIAPHORESIS with HUMIRA (ADALIMUMAB).) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: Abnormal.         It was unknown if patient was enrolled in a covid-19 vaccine trial.  No treatment medication was reported.  The reporter did not provide the causal relationship between Humira and the event diaphoresis. The reporter assessed the causal relationship between Humira and the events of increased rheumatoid arthritis flare ups, premature ventricular contractions as no reason possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment This spontaneous case reported by a consumer, concerns a female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Rheumatoid arthritis (Increased Rheumatoid arthritis flare up) and the non serious, unexpected AESI of ventricular extrasystoles (Premature ventricular contractions), unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious event of Hyperhidrosis. On an unknown date, the patient started on ADALIMUMAB for Rheumatoid Arthritis. Concomitant products included METHOTREXATE for an unknown indication. On an unknown date, Electrocardiogram was abnormal. No further clinical information on comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details  were reported. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Rheumatoid arthritis (Increased Rheumatoid arthritis flare up) and the non serious, unexpected AESI of ventricular extrasystoles (Premature ventricular contractions), unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious event of Hyperhidrosis. On an unknown date, the patient started on ADALIMUMAB for Rheumatoid Arthritis. Concomitant products included METHOTREXATE for an unknown indication. On an unknown date, Electrocardiogram was abnormal. No further clinical information on comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details  were reported. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.