Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Vaccination site haemorrhage
Clinical narrative: Rheumatoid arthritis came back; Blood at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis came back) in a 64-year-old male 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.    Concurrent medical conditions included Rheumatoid arthritis.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-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) 40 milligram. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis came back) (seriousness criterion medically significant) and VACCINATION SITE HAEMORRHAGE (Blood at injection site). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis came back) and VACCINATION SITE HAEMORRHAGE (Blood at injection site) outcome was unknown.            No concomitant medications were reported.  Patient received Humira 40MG/0.4ML (Adalimumab Solution for Injection, Single Dose Pen).  It was reported that on 29-Oct-2022, the patient experienced Injection site welt, the patient Felt the needle going in/when pulled the needle away, lot of the liquid went away/Auto injector solution present on injection site (Inappropriate dose of Drug administered) and on 29-Oct-2022, patient experienced Injection site pain/Humira injection hurt more than normal/Felt pain of needle going in/unusual pain when needle hit skin.  The outcome for the events Injection site pain and Inappropriate dose of Drug administered was reported as Unknown and Not recovered. The outcome for the event Injection site welt or urticaria was unknown.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The reporter's causality for the event(s) of Injection site pain, Inappropriate dose of drug administered, with Adalimumab Solution for Injection was Reasonable Possibility. The reporter's causality for the event(s) of Blood at injection site and Injection site welt with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event(s) of Rheumatoid arthritis came back with Adalimumab Solution for Injection was No Reasonable Possibility.  The other Company's opinion was that the causality for the event(s) of Blood at injection site, Felt the needle going in/when pulled the needle away, lot of the liquid went away/Auto injector solution present on injection site, Injection site pain/Humira injection hurt more than normal/Felt pain of needle going in/unusual pain when needle hit skin, Injection site welt and Rheumatoid arthritis came back with Moderna COVID-19 vaccine (Elasomeran) and Adalimumab Solution for Injection was Not Provided.  Company comment: This spontaneous case concerns a 64-years-old male patient with medical history of Rheumatoid Arthritis that was treated with HUMIRA (ADALIMUMAB), who experienced the unexpected, serious (medically significant) AESI event of Rheumatoid arthritis (Rheumatoid arthritis flare up) among other non-serious events. The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. The Concomitant medication and treatment details were not provided, and the event outcome was unknown. The medical history of Rheumatoid Arthritis treated with HUMIRA remains a confounder to the event. 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.; Sender's Comments: This spontaneous case concerns a 64-years-old male patient with medical history of Rheumatoid Arthritis that was treated with HUMIRA (ADALIMUMAB), who experienced the unexpected, serious (medically significant) AESI event of Rheumatoid arthritis (Rheumatoid arthritis flare up) among other non-serious events. The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. The Concomitant medication and treatment details were not provided, and the event outcome was unknown. The medical history of Rheumatoid Arthritis treated with HUMIRA remains a confounder to the event. 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.