Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Nausea, Pain, Rheumatoid arthritis
Clinical narrative: Recurrent nausea; Recurrent pain/ lot of pain in between armpits and both breasts; Recurrent fatigue; Rheumatoid arthritis; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in a 51-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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Tobacco user (15 to 20 cigarrette sticks a day started 1984.) since 1984, Drug allergy (Codeine allergy manifested by itch everywhere.), Egg allergy (manifested by gastro intestinal or stomach related reactions.) and Rheumatoid arthritis. Concomitant products included METHOTREXATE and PREDNISONE for Rheumatoid arthritis.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In March 2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant) and FATIGUE (Recurrent fatigue). In April 2022, the patient experienced PAIN (Recurrent pain/ lot of pain in between armpits and both breasts). On 18-Apr-2022, the patient experienced NAUSEA (Recurrent nausea). On 19-Apr-2022, PAIN (Recurrent pain/ lot of pain in between armpits and both breasts) and NAUSEA (Recurrent nausea) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis) and FATIGUE (Recurrent fatigue) had not resolved.            No treatment medications were reported. Patient past medications was reported as Codeine for unknown indication. Reporters causality for all events was not assessable with respect to Humira drug. 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 is a spontaneous case concerning a 51-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis, 9 months after receiving the second dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 51-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis, 9 months after receiving the second dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.