Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Hypoxia, Immunodeficiency, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Arthritis; Received 1st dose of moderna COVID-19 vaccine on 01-Mar-2021 and 2nd dose on 22-Mar-2021; PAIN IN LEFT HAND; RHEUMATOID ARTHRITIS DELETE OXYGEN AND LOWERD IMMUNE SYSTEM; RHEUMATOID ARTHRITIS DELETE OXYGEN AND LOWERD IMMUNE SYSTEM; RHEUMATOID ARTHRITIS DELETE OXYGEN AND LOWERD IMMUNE SYSTEM; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS DELETE OXYGEN AND LOWERD IMMUNE SYSTEM), HYPOXIA (RHEUMATOID ARTHRITIS DELETE OXYGEN AND LOWERD IMMUNE SYSTEM) and IMMUNODEFICIENCY (RHEUMATOID ARTHRITIS DELETE OXYGEN AND LOWERD IMMUNE SYSTEM) in a 67-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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 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 22-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 1st dose of moderna COVID-19 vaccine on 01-Mar-2021 and 2nd dose on 22-Mar-2021). In 2021, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS DELETE OXYGEN AND LOWERD IMMUNE SYSTEM) (seriousness criterion medically significant), HYPOXIA (RHEUMATOID ARTHRITIS DELETE OXYGEN AND LOWERD IMMUNE SYSTEM) (seriousness criterion medically significant), IMMUNODEFICIENCY (RHEUMATOID ARTHRITIS DELETE OXYGEN AND LOWERD IMMUNE SYSTEM) (seriousness criterion medically significant) and PAIN IN EXTREMITY (PAIN IN LEFT HAND). On an unknown date, the patient experienced ARTHRITIS (Arthritis). The patient was treated with MELOXICAM at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS DELETE OXYGEN AND LOWERD IMMUNE SYSTEM), ARTHRITIS (Arthritis) and PAIN IN EXTREMITY (PAIN IN LEFT HAND) had not resolved and HYPOXIA (RHEUMATOID ARTHRITIS DELETE OXYGEN AND LOWERD IMMUNE SYSTEM), IMMUNODEFICIENCY (RHEUMATOID ARTHRITIS DELETE OXYGEN AND LOWERD IMMUNE SYSTEM) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 1st dose of moderna COVID-19 vaccine on 01-Mar-2021 and 2nd dose on 22-Mar-2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment information was provided.  The reporter's causality with Humira (adalimumab) for the events Hand pain, Rheumatoid arthritis and Arthritis was no reasonable possibility and not Reported for events Immunodeficiency and Hypoxia.  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 67-year-old, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) events of rheumatoid arthritis (AESI), hypoxia and immunodeficiency, and the unexpected, non-serious events of arthritis (AESI) and pain in extremity (pain in left hand). The event arthritis occurred unknown number of days after receiving Humira and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the administration date of Humira and the event onset date were not provided, hence, the onset latency could not be assessed. The other events occurred unknown number of days after receiving Humira and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. It was reported that the patient was treated with meloxicam (unspecified indication, dose, frequency and duration). The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the events rheumatoid arthritis and arthritis. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) events of rheumatoid arthritis (AESI), hypoxia and immunodeficiency, and the unexpected, non-serious events of arthritis (AESI) and pain in extremity (pain in left hand). The event arthritis occurred unknown number of days after receiving Humira and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the administration date of Humira and the event onset date were not provided, hence, the onset latency could not be assessed. The other events occurred unknown number of days after receiving Humira and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. It was reported that the patient was treated with meloxicam (unspecified indication, dose, frequency and duration). The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the events rheumatoid arthritis and arthritis. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.