Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Foot fracture, Kidney infection, Memory impairment, Panic attack
Clinical narrative: Rheumatoid arthritis flare up; Kidney infection; Ulcer; Forgetfulness; Fractured toe; Panic attacks; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and KIDNEY INFECTION (Kidney infection) in an adult 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.    No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-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) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), KIDNEY INFECTION (Kidney infection) (seriousness criterion medically significant), ULCER (Ulcer), MEMORY IMPAIRMENT (Forgetfulness), FOOT FRACTURE (Fractured toe) and PANIC ATTACK (Panic attacks). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), KIDNEY INFECTION (Kidney infection), ULCER (Ulcer), FOOT FRACTURE (Fractured toe) and PANIC ATTACK (Panic attacks) had not resolved and MEMORY IMPAIRMENT (Forgetfulness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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 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) and unexpected serious (medically significant) event of Kidney infection, among other non-serious events. The events occurred on an unknown date in context to second dose of mRNA-1273 vaccine. Latency cannot be assessed since event onset date was not disclosed. The Clinical course, Concomitant medication 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.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow up received and updated event information.; 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) and unexpected serious (medically significant) event of Kidney infection, among other non-serious events. The events occurred on an unknown date in context to second dose of mRNA-1273 vaccine. Latency cannot be assessed since event onset date was not disclosed. The Clinical course, Concomitant medication 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.