Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cystitis, Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Rheumatoid arthritis inflammation levels elevated/rheumatoid arthritis flare up; Chronic bladder infection; Sore arm after covid vaccines; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis inflammation levels elevated/rheumatoid arthritis flare up) in a 79-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.    The patient's past medical history included Knee operation in September 2020. Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe ).   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-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) UNK, Citrate Free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, Citrate Free and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, Citrate Free. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis inflammation levels elevated/rheumatoid arthritis flare up) (seriousness criterion medically significant), CYSTITIS (Chronic bladder infection) and VACCINATION SITE PAIN (Sore arm after covid vaccines). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis inflammation levels elevated/rheumatoid arthritis flare up) and CYSTITIS (Chronic bladder infection) had not resolved and VACCINATION SITE PAIN (Sore arm after covid vaccines) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Rheumatoid Arthritis inflammation levels were elevated.         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.  No concomitant medication was reported.  On an unknown date, left knee surgery was resolved. The formulation for Humira was reported as Solution for injection in pre-filled pen. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The patient family member reported reporter causality for the event knee replacement as reasonable possibility.  The reporter's causality for the events of left knee surgery, sore arm after Covid vaccines, back pain from falling unknown onset, chronic bladder infection and back pain from falling unknown onset with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the events of patient took Humira injection one week earlier then prescribed and rheumatoid arthritis inflammation levels elevated/rheumatoid arthritis flare up with Humira(adalimumab) was a reasonable possibility.  Company Comment: This spontaneous case concerns a 79-year-old, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, medically significant AESI Rheumatoid arthritis (RA) flare up in association with a dose of mRNA-1273 vaccine. Patient received a 2-dose primary series of mRNA-1273 vaccine at 30 days apart, followed by a 3rd dose. Event RA flare up started approximately 7 months before her 1st vaccination and persisted thereafter. Patient may have experienced back pain flare up, shoulder pain, fatigue, and neck pain during RA flare up. Inflammation levels were elevated. Patient reported sore arm after receiving mRNA-1273 vaccines. Patient's underlying rheumatoid arthritis and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on m   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Live follow up appended- New event added. On 28-Mar-2022: Live follow up appended. The event back pain flare up was removed, suspect drug information was updated and narrative was updated.; Sender's Comments: This spontaneous case concerns a 79-year-old, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, medically significant AESI Rheumatoid arthritis (RA) flare up in association with a dose of mRNA-1273 vaccine. Patient received a 2-dose primary series of mRNA-1273 vaccine at 30 days apart, followed by a 3rd dose. Event RA flare up started approximately 7 months before her 1st vaccination and persisted thereafter. Patient may have experienced back pain flare up, shoulder pain, fatigue, and neck pain during RA flare up. Inflammation levels were elevated. Patient reported sore arm after receiving mRNA-1273 vaccines. Patient's underlying rheumatoid arthritis and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.