Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rheumatoid arthritis, Weight, Weight decreased
Clinical narrative: Arthritis rheumatoid aggravated/ return of rheumatoid arthritis; lost weight due to not being able to enjoy food; Flu-like aching; Asthma; Swelling of hands; Pain in hand; Numbness in hand; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Arthritis rheumatoid aggravated/ return of rheumatoid arthritis) in a 61-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) injection for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. In February 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Arthritis rheumatoid aggravated/ return of rheumatoid arthritis) (seriousness criterion medically significant), WEIGHT DECREASED (lost weight due to not being able to enjoy food), INFLUENZA LIKE ILLNESS (Flu-like aching), ASTHMA (Asthma), PERIPHERAL SWELLING (Swelling of hands), PAIN IN EXTREMITY (Pain in hand) and HYPOAESTHESIA (Numbness in hand). In 2021, COVID-19 (COVID-19) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Arthritis rheumatoid aggravated/ return of rheumatoid arthritis), PERIPHERAL SWELLING (Swelling of hands), PAIN IN EXTREMITY (Pain in hand) and HYPOAESTHESIA (Numbness in hand) had not resolved and WEIGHT DECREASED (lost weight due to not being able to enjoy food), INFLUENZA LIKE ILLNESS (Flu-like aching) and ASTHMA (Asthma) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: Loss.         Humira was not working as well as it used to and not been taking Humira consistently. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concomitant medications were not reported.  No treatment information was provided by the reporter.  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 61-year-old, female patient with relevant medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab) with poor compliance, who experienced the unexpected, serious (medically significant) AESI of rheumatoid arthritis (rheumatoid arthritis aggravated), the unexpected, non-serious AESI of COVID-19, and other unexpected, non-serious events. The event COVID-19 occurred unknown number of days before receiving the first dose of the mRNA-1273 vaccine. The start dates of the other events were not provided, hence, the onset latency could not be assessed. Moreover, it could not be assessed if the events occurred after the first dose or the second dose of the mRNA-1273 vaccine. On an unspecified date in Feb2021, it was reported that the patient experienced COVID-19. No symptoms were reported and treatment information was not provided. However, the event had resolved on an unspecified date in 2021. On unknown dates, it was reported that the patient experienced Rheumatoid Arthritis flare-up (pain in knees returned). Of note, it was reported that Humira was 'not working as well as it used to' and the patient had not been receiving Humira consistently. The patient also experienced weight loss (unspecified amount of weight) due to not being able to enjoy food, flu-like pain, asthma, swelling in hands and fingers, pain in hands and fingers (felt like a toothache in hands), and numbness in hands and fingers. Treatment information was not provided. Of note, the reporter assessed the events as not related to the mRNA-1273 vaccine. The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the event rheumatoid arthritis aggravated. It also remains a confounder for the events peripheral swelling and pain in extremity (swelling and pain in fingers) which are common symptoms of Rheumatoid Arthritis. The history of co-suspect administration of Humira with poor compliance also remains a confounder for the event rheumatoid arthritis aggravated. Humira also remains a confounder for the other non-serious events, except for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61-year-old, female patient with relevant medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab) with poor compliance, who experienced the unexpected, serious (medically significant) AESI of rheumatoid arthritis (rheumatoid arthritis aggravated), the unexpected, non-serious AESI of COVID-19, and other unexpected, non-serious events. The event COVID-19 occurred unknown number of days before receiving the first dose of the mRNA-1273 vaccine. The start dates of the other events were not provided, hence, the onset latency could not be assessed. Moreover, it could not be assessed if the events occurred after the first dose or the second dose of the mRNA-1273 vaccine. On an unspecified date in Feb2021, it was reported that the patient experienced COVID-19. No symptoms were reported and treatment information was not provided. However, the event had resolved on an unspecified date in 2021. On unknown dates, it was reported that the patient experienced Rheumatoid Arthritis flare-up (pain in knees returned). Of note, it was reported that Humira was 'not working as well as it used to' and the patient had not been receiving Humira consistently. The patient also experienced weight loss (unspecified amount of weight) due to not being able to enjoy food, flu-like pain, asthma, swelling in hands and fingers, pain in hands and fingers (felt like a toothache in hands), and numbness in hands and fingers. Treatment information was not provided. Of note, the reporter assessed the events as not related to the mRNA-1273 vaccine. The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the event rheumatoid arthritis aggravated. It also remains a confounder for the events peripheral swelling and pain in extremity (swelling and pain in fingers) which are common symptoms of Rheumatoid Arthritis. The history of co-suspect administration of Humira with poor compliance also remains a confounder for the event rheumatoid arthritis aggravated. Humira also remains a confounder for the other non-serious events, except for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.