Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Skin papilloma, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Rheumatoid arthritis flare up in both wrists with Humira (adalimumab).; Plantars wart on left foot; Had booster shot of Moderna covid-19 vaccine and had reaction of red, swollen, and painful arm; Had booster shot of Moderna covid-19 vaccine and had reaction of red, swollen, and painful arm; Had booster shot of Moderna covid-19 vaccine and had reaction of red, swollen, and painful arm; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in both wrists with Humira (adalimumab).) in a female patient of an unknown age 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 Rheumatoid arthritis.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Aug-2021, received third 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) at an unspecified dose. On 25-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Had booster shot of Moderna covid-19 vaccine and had reaction of red, swollen, and painful arm), VACCINATION SITE PAIN (Had booster shot of Moderna covid-19 vaccine and had reaction of red, swollen, and painful arm) and VACCINATION SITE SWELLING (Had booster shot of Moderna covid-19 vaccine and had reaction of red, swollen, and painful arm). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in both wrists with Humira (adalimumab).) (seriousness criterion medically significant) and SKIN PAPILLOMA (Plantars wart on left foot). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in both wrists with Humira (adalimumab).) had not resolved and SKIN PAPILLOMA (Plantars wart on left foot), VACCINATION SITE ERYTHEMA (Had booster shot of Moderna covid-19 vaccine and had reaction of red, swollen, and painful arm), VACCINATION SITE PAIN (Had booster shot of Moderna covid-19 vaccine and had reaction of red, swollen, and painful arm) and VACCINATION SITE SWELLING (Had booster shot of Moderna covid-19 vaccine and had reaction of red, swollen, and painful arm) outcome was unknown.            No concomitant medications were reported.   On unknown dates, the patient experienced plantars wart on left foot and rheumatoid arthritis flare up in both wrists. on 25-Aug-2021, the patient had booster shot of Moderna Covid-19 vaccine and had reaction of red, swollen and painful arm. It was unknown if patient was enrolled in a Covid-19 vaccine trial.   The reporter's causality for the event(s) of had booster shot of Moderna covid-19 vaccine and had reaction of red, swollen and painful arm onset 25-Aug-2021, had booster shot of moderna covid-19 vaccine and had reaction of red, swollen and painful arm onset 25-Aug-2021, had booster shot of Moderna covid-19 vaccine and had reaction of red, swollen and painful arm onset 25-Aug-2021 and plantars wart on left foot with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of rheumatoid arthritis flare up in both wrists with Humira (adalimumab) was a reasonable possibility.  No treatment details 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 an adult female patient of unspecified age 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 events occurred on an unknown date in context to third dose of mRNA-1273 vaccine. Latency cannot be assessed since event onset date was not disclosed. The Clinical course, and treatment details were not provided, and the event outcome was not resolved. 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.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an adult female patient of unspecified age 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 events occurred on an unknown date in context to third dose of mRNA-1273 vaccine. Latency cannot be assessed since event onset date was not disclosed. The Clinical course, and treatment details were not provided, and the event outcome was not resolved. 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.