Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Weight increased, White blood cell count increased
Clinical narrative: Asthma aggravated; Weight gain; Rash urticarial; Rheumatoid arthritis flare up; Skin rash; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 44-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.    The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Rheumatoid arthritis.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In May 2021, the patient experienced URTICARIA (Rash urticarial). In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and RASH (Skin rash). On an unknown date, the patient experienced ASTHMA (Asthma aggravated) and WEIGHT INCREASED (Weight gain). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), ASTHMA (Asthma aggravated), WEIGHT INCREASED (Weight gain) and URTICARIA (Rash urticarial) outcome was unknown and RASH (Skin rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, COVID-19: (Positive) patient experienced COVID-19. On 26-Jun-2021, Blood test: elevated white blood cells. On 26-Jun-2021, White blood cell count increased: Increased.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient also received third dose COVID-19 vaccine. No concomitant medication information was reported. No treatment medication information was reported.  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 concerns a 44-year-old female patient with relevant medical history of Rheumatoid Arthritis that was treated with Adalimumab (Humira), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) that occurred in the context of third dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient also experienced non serious events of Asthma, Weight increased, Rash, and Urticaria. She had received two doses of mRNA-1273 at an interval of 30 days. The Clinical course, Concomitant medication, investigations, treatment details were not available. Outcome of event Rheumatoid Arthritis was reported as unknown. The medical history of Rheumatoid Arthritis remains a confounder to the event Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-623361 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Significant follow up: Event added. On 20-Oct-2021: Significant follow up: Event added.; Sender's Comments: This spontaneous case concerns a 44-year-old female patient with relevant medical history of Rheumatoid Arthritis that was treated with Adalimumab (Humira), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) that occurred in the context of third dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient also experienced non serious events of Asthma, Weight increased, Rash, and Urticaria. She had received two doses of mRNA-1273 at an interval of 30 days. The Clinical course, Concomitant medication, investigations, treatment details were not available. Outcome of event Rheumatoid Arthritis was reported as unknown. The medical history of Rheumatoid Arthritis remains a confounder to the event Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.