Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; FELT RUN DOWN; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 59-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 product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    There was no reported medical history.  Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for an unknown indication.   On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Discontinued. In 2021, the patient experienced FATIGUE (FELT RUN DOWN). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and FATIGUE (FELT RUN DOWN) outcome was unknown.            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   It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.  The reporter's causality for the event(s) of felt run down and rheumatoid arthritis flare up was not provided.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a 59-year-old female patient with relevant medical condition of moderate to severe Rheumatoid arthritis, who experienced the unexpected serious (medically significant) adverse event of special interest Rheumatoid arthritis, reported as rheumatoid arthritis flare up, in the context of a 2 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since the event onset date was not provided. Patient had received a dose mRNA-1273 vaccine given on an unknown date and another dose of mRNA-1273 as third/booster dose of COVID-19 vaccine. No information disclosed on previous COVID-19 vaccination. The patient also experienced tiredness. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The medical condition of moderate to severe Rheumatoid arthritis remains as a confounder for the Rheumatoid arthritis flare up. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 59-year-old female patient with relevant medical condition of moderate to severe Rheumatoid arthritis, who experienced the unexpected serious (medically significant) adverse event of special interest Rheumatoid arthritis, reported as rheumatoid arthritis flare up, in the context of a 2 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since the event onset date was not provided. Patient had received a dose mRNA-1273 vaccine given on an unknown date and another dose of mRNA-1273 as third/booster dose of COVID-19 vaccine. No information disclosed on previous COVID-19 vaccination. The patient also experienced tiredness. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The medical condition of moderate to severe Rheumatoid arthritis remains as a confounder for the Rheumatoid arthritis flare up. The benefit-risk relationship of mRNA-1273 is not affected by this report.