Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, UNK, UNK
Symptoms: Somnolence, Stress, Swelling, Temperature intolerance, Therapeutic response shortened
Clinical narrative: Drug-induced liver disease; Rheumatoid arthritis/rheumatoid arthritis causes swelling in different parts/got in eyes; Sleepiness after second dose of vaccine/sleepy; Feeling abnormal/felt out of sorts after second dose of covid vaccination; Loss of energy; feeling unwell; Fingers stiffness/stiffness in right thumb/index finger; Stress; Swelling of feet/swelling in feet with HUMIRA; swelling in kunckles/Joint swelling of hand; achiness with HUMIRA (adalimumab)/achiness/soreness; Inflammation/tired/few days before humira feels fatigue and hands were getting inflammed/Inflammation localised; Ankle arthropathy/ indentation in ankle; Humidity intolerance/swelling sometimes in the mornings before did exercise/heat/humidity sometimes caused swelling; Heat intolerance/swelling sometimes in the mornings before did exercise/heat/humidity sometimes caused swelling; Liver disorder/methotrexate messed up with liver; AST high; Red hands/hands got red with HUMIRA; ALT high; Wearing off effect; Local swelling; Vaccination site pain; Rash over arms; Headache; Fatigue/few days before humira feels fatigue and hands were getting inflammed; Knee pain; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; Fatigue aggravated/fatigue after first and second dose of covid vaccinations/worse with second dose; Vaccination site pain/achy arm after fisrt and second dose of covid vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of DRUG-INDUCED LIVER INJURY (Drug-induced liver disease) and 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) injection 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 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient received third 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 aggravated/fatigue after first and second dose of covid vaccinations/worse with second dose) and VACCINATION SITE PAIN (Vaccination site pain/achy arm after fisrt and second dose of covid vaccinations). On an unknown date, the patient experienced DRUG-INDUCED LIVER INJURY (Drug-induced liver disease) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (Rheumatoid arthritis/rheumatoid arthritis causes swelling in different parts/got in eyes) (seriousness criterion medically significant), SOMNOLENCE (Sleepiness after second dose of vaccine/sleepy), FEELING ABNORMAL (Feeling abnormal/felt out of sorts after second dose of covid vaccination), ASTHENIA (Loss of energy), MALAISE (feeling unwell), MUSCULOSKELETAL STIFFNESS (Fingers stiffness/stiffness in right thumb/index finger), STRESS (Stress), PERIPHERAL SWELLING (Swelling of feet/swelling in feet with HUMIRA), JOINT SWELLING (swelling in kunckles/Joint swelling of hand), PAIN (achiness with HUMIRA (adalimumab)/achiness/soreness), INFLAMMATION (Inflammation/tired/few days before humira feels fatigue and hands were getting inflammed/Inflammation localised), ARTHROPATHY (Ankle arthropathy/ indentation in ankle), HUMIDITY INTOLERANCE (Humidity intolerance/swelling sometimes in the mornings before did exercise/heat/humidity sometimes caused swelling), TEMPERATURE INTOLERANCE (Heat intolerance/swelling sometimes in the mornings before did exercise/heat/humidity sometimes caused swelling), LIVER DISORDER (Liver disorder/methotrexate messed up with liver), ASPARTATE AMINOTRANSFERASE INCREASED (AST high), ERYTHEMA (Red hands/hands got red with HUMIRA), ALANINE AMINOTRANSFERASE INCREASED (ALT high), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), SWELLING (Local swelling), VACCINATION SITE PAIN (Vaccination site pain), RASH (Rash over arms), HEADACHE (Headache), FATIGUE (Fatigue/few days before humira feels fatigue and hands were getting inflammed), ARTHRALGIA (Knee pain), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, DRUG-INDUCED LIVER INJURY (Drug-induced liver disease), RHEUMATOID ARTHRITIS (Rheumatoid arthritis/rheumatoid arthritis causes swelling in different parts/got in eyes), STRESS (Stress), PERIPHERAL SWELLING (Swelling of feet/swelling in feet with HUMIRA), JOINT SWELLING (swelling in kunckles/Joint swelling of hand), PAIN (achiness with HUMIRA (adalimumab)/achiness/soreness), INFLAMMATION (Inflammation/tired/few days before humira feels fatigue and hands were getting inflammed/Inflammation localised), ARTHROPATHY (Ankle arthropathy/ indentation in ankle), ASPARTATE AMINOTRANSFERASE INCREASED (AST high), ERYTHEMA (Red hands/hands got red with HUMIRA), ALANINE AMINOTRANSFERASE INCREASED (ALT high), SWELLING (Local swelling), FATIGUE (Fatigue aggravated/fatigue after first and second dose of covid vaccinations/worse with second dose) and ARTHRALGIA (Knee pain) had not resolved, SOMNOLENCE (Sleepiness after second dose of vaccine/sleepy), FEELING ABNORMAL (Feeling abnormal/felt out of sorts after second dose of covid vaccination), ASTHENIA (Loss of energy), MALAISE (feeling unwell), MUSCULOSKELETAL STIFFNESS (Fingers stiffness/stiffness in right thumb/index finger), VACCINATION SITE PAIN (Vaccination site pain/achy arm after fisrt and second dose of covid vaccinations), HEADACHE (Headache) and FATIGUE (Fatigue/few days before humira feels fatigue and hands were getting inflammed) had resolved, HUMIDITY INTOLERANCE (Humidity intolerance/swelling sometimes in the mornings before did exercise/heat/humidity sometimes caused swelling), TEMPERATURE INTOLERANCE (Heat intolerance/swelling sometimes in the mornings before did exercise/heat/humidity sometimes caused swelling), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), VACCINATION SITE PAIN (Vaccination site pain), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown and LIVER DISORDER (Liver disorder/methotrexate messed up with liver) 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: Showed methotrexate was messing with liver..         No concomitant medication details were provided. No treatment medication details were provided.   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.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 is a spontaneous case concerning a 64-year-old female patient with medical history of Rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse events of special interest of Drug-induced liver injury and Rheumatoid arthritis, after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the events, clinical course and further treatment details were not provided in the case. History of medication use of Adalimumab and Methotrexate remain as confounders for the event of Drug-induced liver injury. Medical history of Rheumatoid arthritis remains a risk factor for the event of Rheumatoid arthritis. Revaccination with different COVID-19 vaccine and Interchange of vaccine products were also reported as the patient received other COVID-19 vaccine (Pfizer/Biontech) approximately 7 months after the second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2022-624394 (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.; Sender's Comments: This is a spontaneous case concerning a 64-year-old female patient with medical history of Rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse events of special interest of Drug-induced liver injury and Rheumatoid arthritis, after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the events, clinical course and further treatment details were not provided in the case. History of medication use of Adalimumab and Methotrexate remain as confounders for the event of Drug-induced liver injury. Medical history of Rheumatoid arthritis remains a risk factor for the event of Rheumatoid arthritis. Revaccination with different COVID-19 vaccine and Interchange of vaccine products were also reported as the patient received other COVID-19 vaccine (Pfizer/Biontech) approximately 7 months after the second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.