Sex: F
Vaccine: COVID19, UNK
Symptoms: Therapeutic product effect decreased
Clinical narrative: DECREASE IN IMPROVEMENTS FROM HUMIRA SINCE COVID BOOSTER with HUMIRA; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (DECREASE IN IMPROVEMENTS FROM HUMIRA SINCE COVID BOOSTER with HUMIRA) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (DECREASE IN IMPROVEMENTS FROM HUMIRA SINCE COVID BOOSTER with HUMIRA). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (DECREASE IN IMPROVEMENTS FROM HUMIRA SINCE COVID BOOSTER with HUMIRA) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no reported medical history.  Concomitant Drugs Not Reported. On an unknown date, the patient experienced DECREASE IN IMPROVEMENTS FROM HUMIRASINCE COVID BOOSTER. MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA1273)) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received 1st dose COVID-19 Vaccine manufactured by MODERNA COVID-19 VACCINE.. No treatment medication was reported. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of DECREASE IN IMPROVEMENTS FROM HUMIRA SINCE COVID BOOSTER with HUMIRA(ADALIMUMAB) was no reasonable possibility.  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 with concurrent condition of rheumatoid arthritis and reported non serious event of Therapeutic product effect decreased (reported as DECREASE IN IMPROVEMENTS FROM HUMIRA SINCE COVID BOOSTER with HUMIRA), unknown days after receiving the first dose of mRNA-1273 vaccine. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 and the second dose details was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Live Non-Significant Follow Up received: No new information reported.; Sender's Comments: This spontaneous case concerns an adult female patient with concurrent condition of rheumatoid arthritis and reported non serious event of Therapeutic product effect decreased (reported as DECREASE IN IMPROVEMENTS FROM HUMIRA SINCE COVID BOOSTER with HUMIRA), unknown days after receiving the first dose of mRNA-1273 vaccine. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 and the second dose details was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.