Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased, White blood cell count, White blood cell count increased
Clinical narrative: Asthma aggravated; Walking with a limp; Weight gain; Elevated white blood cells; Skin rash after both doses of covid vaccines; Rheumatoid arthritis flare up after COVID vaccination; This spontaneous case was reported by a non-health professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up after COVID vaccination) 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) solution for injection for Rheumatoid arthritis.    The patient's past medical history included COVID-19 in December 2020.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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) Citrate Free. In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up after COVID vaccination) (seriousness criterion medically significant) and RASH (Skin rash after both doses of covid vaccines). On 26-Jun-2021, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Elevated white blood cells). On an unknown date, the patient experienced ASTHMA (Asthma aggravated), GAIT DISTURBANCE (Walking with a limp) and WEIGHT INCREASED (Weight gain). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up after COVID vaccination), ASTHMA (Asthma aggravated), GAIT DISTURBANCE (Walking with a limp) and WEIGHT INCREASED (Weight gain) outcome was unknown and WHITE BLOOD CELL COUNT INCREASED (Elevated white blood cells) and RASH (Skin rash after both doses of covid vaccines) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jun-2021, White blood cell count: Elevated. On an unknown date, Weight: Gain.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported. No treatment medications were 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-years-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 (Rheumatoid arthritis flare up) among other non-serious events. The event occurred on an unknown date in context to third dose of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date was not disclosed. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   This case was linked to MOD-2021-621850 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Event 'Asthma aggravated' added. On 20-Oct-2021: Event 'Weight gain' added.; Sender's Comments: This spontaneous case concerns a 44-years-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 (Rheumatoid arthritis flare up) among other non-serious events. The event occurred on an unknown date in context to third dose of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date was not disclosed. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.