Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, UNK, UNK
Symptoms: Swelling, Temperature intolerance, Therapeutic response shortened, Vaccination site pain
Clinical narrative: Rheumatoid arthritis/rheumatoid arthritis causes swelling in different parts/got in eyes; Stress; Sleepiness/Sleepy; Humidity intolerance; Heat intolerance; Liver disorder; Feeling unwell; Loss of energy; SWELLING SOMETIMES IN THE MORNINGS BEFORE DID EXERCISE/HEAT/HUMIDITY SOMETIMES CAUSED SWELLING; Inflammation/tired/few days before humira feels fatigue and hands were getting inflammed/Inflammation localized; Ankle arthropathy/indentation in ankle; AST high; ALT high; Wearing off effect; Red hands/hands got red with HUMIRA; Fatigue; Vaccination site pain; Rash over arms; Headache; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; FATIGUE AFTER FISRT DOSE OF COVID VACCINATIONS; Vaccination site pain/achy arm after first and second dose of covid vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis/rheumatoid arthritis causes swelling in different parts/got in eyes) in a 64-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 products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, METHOTREXATE for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Rheumatoid arthritis.   On 25-Jul-2019, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. and METHOTREXATE (unknown route) at an unspecified dose. In 2021, the patient experienced FATIGUE (FATIGUE AFTER FISRT DOSE OF COVID VACCINATIONS) and VACCINATION SITE PAIN (Vaccination site pain/achy arm after first and second dose of covid vaccinations). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis/rheumatoid arthritis causes swelling in different parts/got in eyes) (seriousness criterion medically significant), STRESS (Stress), SOMNOLENCE (Sleepiness/Sleepy), HUMIDITY INTOLERANCE (Humidity intolerance), TEMPERATURE INTOLERANCE (Heat intolerance), LIVER DISORDER (Liver disorder), MALAISE (Feeling unwell), ASTHENIA (Loss of energy), SWELLING (SWELLING SOMETIMES IN THE MORNINGS BEFORE DID EXERCISE/HEAT/HUMIDITY SOMETIMES CAUSED SWELLING), INFLAMMATION (Inflammation/tired/few days before humira feels fatigue and hands were getting inflammed/Inflammation localized), ARTHROPATHY (Ankle arthropathy/indentation in ankle), ASPARTATE AMINOTRANSFERASE INCREASED (AST high), ALANINE AMINOTRANSFERASE INCREASED (ALT high), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), ERYTHEMA (Red hands/hands got red with HUMIRA), FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain), RASH (Rash over arms), HEADACHE (Headache), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis/rheumatoid arthritis causes swelling in different parts/got in eyes), STRESS (Stress), SWELLING (SWELLING SOMETIMES IN THE MORNINGS BEFORE DID EXERCISE/HEAT/HUMIDITY SOMETIMES CAUSED SWELLING), INFLAMMATION (Inflammation/tired/few days before humira feels fatigue and hands were getting inflammed/Inflammation localized), ARTHROPATHY (Ankle arthropathy/indentation in ankle), ASPARTATE AMINOTRANSFERASE INCREASED (AST high), ALANINE AMINOTRANSFERASE INCREASED (ALT high), ERYTHEMA (Red hands/hands got red with HUMIRA) and FATIGUE (FATIGUE AFTER FISRT DOSE OF COVID VACCINATIONS) had not resolved, SOMNOLENCE (Sleepiness/Sleepy), MALAISE (Feeling unwell), ASTHENIA (Loss of energy), VACCINATION SITE PAIN (Vaccination site pain/achy arm after first and second dose of covid vaccinations), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved, HUMIDITY INTOLERANCE (Humidity intolerance), TEMPERATURE INTOLERANCE (Heat intolerance), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), VACCINATION SITE PAIN (Vaccination site pain), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown and LIVER DISORDER (Liver disorder) and RASH (Rash over arms) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: High. On an unknown date, Aspartate aminotransferase: High. On an unknown date, Blood test: methotrexate was messing with liver.         No concomitant medication details were provided. No treatment medication details were provided.   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.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter's causality for the events of stressed and inflammation with HUMIRA(ADALIMUMAB) was a reasonable possibility, while not provided for the other events. The reporter's causality for all the events was not with PFIZER BIONTECH COVID-19 vaccine and Methotrexate.   This case was linked to MOD-2022-624084 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Significant Follow-up appended: Added events and update information in I-narrative supplement. On 07-Sep-2022: Significant Follow-up appended: Added events, lab data, co-suspect drug details, update outcome for events and information in I-narrative supplement.  Company comment: This spontaneous case concerns a 64-year-old, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab) and history of receiving the other co-suspect products methotrexate (unknown indication) and the booster dose of the Pfizer/BioNTech COVID-19 mRNA vaccine, who experienced the unexpected, serious (medically significant) AESI of rheumatoid arthritis, the unexpected, non-serious AESI of liver disorder, and other unexpected and expected, non-serious events. The events occurred unknown number of days after receiving Humira, unknown number of days after receiving methotrexate, and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced swelling sometimes in the mornings before she did exercise, heat/humidity sometimes caused swelling, tired a few days before receiving Humira, felt fatigue and hands got inflammed, felt sleepy, not feeling well, fatigue, loss of energy, stress, inflammation, rheumatoid arthritis caused swelling in different parts, indentation in ankle, achiness/soreness, rash on arm, rheumatoid arthritis got in eyes, headache, and erythematous hands. It was also reported that methotrexate 'messed up' with the patient's liver. On unspecified dates, the liver enzymes (Aspartate aminotransferase and Alanine aminotransferase) were found to be elevated. Treatment information was not provided. Of note, the patient also received the second dose of the mRNA-1273 vaccine 28 days after the first dose of the mRNA-1273 vaccine, and the booster dose of the Pfizer/BioNTech COVID-19 mRNA vaccine (revaccination with different COVID-19 vaccine and interchange of vaccine products) approximately 7 months after the second dose of the mRNA-1273 vaccine. The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the event rheumatoid arthritis. The use of the co-suspect product methotrexate, which may cause the common side effect of abnormal liver function tests, remains a confounder for the event liver disorder. The co-suspect products Humira and methotrexate also remain as confounders for the other events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 64-year-old, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab) and history of receiving the other co-suspect products methotrexate (unknown indication) and the booster dose of the Pfizer/BioNTech COVID-19 mRNA vaccine, who experienced the unexpected, serious (medically significant) AESI of rheumatoid arthritis, the unexpected, non-serious AESI of liver disorder, and other unexpected and expected, non-serious events. The events occurred unknown number of days after receiving Humira, unknown number of days after receiving methotrexate, and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced swelling sometimes in the mornings before she did exercise, heat/humidity sometimes caused swelling, tired a few days before receiving Humira, felt fatigue and hands got inflammed, felt sleepy, not feeling well, fatigue, loss of energy, stress, inflammation, rheumatoid arthritis caused swelling in different parts, indentation in ankle, achiness/soreness, rash on arm, rheumatoid arthritis got in eyes, headache, and erythematous hands. It was also reported that methotrexate 'messed up' with the patient's liver. On unspecified dates, the liver enzymes (Aspartate aminotransferase and Alanine aminotransferase) were found to be elevated. Treatment information was not provided. Of note, the patient also received the second dose of the mRNA-1273 vaccine 28 days after the first dose of the mRNA-1273 vaccine, and the booster dose of the Pfizer/BioNTech COVID-19 mRNA vaccine (revaccination with different COVID-19 vaccine and interchange of vaccine products) approximately 7 months after the second dose of the mRNA-1273 vaccine. The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the event rheumatoid arthritis. The use of the co-suspect product methotrexate, which may cause the common side effect of abnormal liver function tests, remains a confounder for the event liver disorder. The co-suspect products Humira and methotrexate also remain as confounders for the other events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.