Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Myalgia, Pyrexia, Stress
Clinical narrative: Stress; Extreme fatigue; Muscle aches; Fever; Recurrent joint pain; Recurrent low grade fever; Recurrent joint swelling; Recurrent joint stiffness; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Recurrent joint swelling), JOINT STIFFNESS (Recurrent joint stiffness), STRESS (Stress), ARTHRALGIA (Recurrent joint pain) and PYREXIA (Recurrent low grade fever) in a 40-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 Hip fracture (Both hip bones were resculptured and had to restructure the part of the hip/right hip reconstruction), Tobacco user (tobacco use one pack of cigarettes per day) from 01-Feb-1998 to 2001, Hip replacement (Both hip bones were resculptured and had to restructure the part of the hip/right hip reconstruction) in 2016, Hand reconstructive surgery (reconstruction on right hand after third degree burn) in July 1980, Appendectomy in 1988 and Eyelid operation (right eyelid reconstruction surgery) in 1996. Previously administered products included for Drug use for unknown indication: METHOTREXATE, FLEXERIL and FOLIC ACID. Past adverse reactions to the above products included No adverse reaction with FLEXERIL, FOLIC ACID and METHOTREXATE. Concurrent medical conditions included Alcohol use (alcohol use/one can of malt alcohol once a year) since 01-Jan-2005, Rheumatoid arthritis since 2017, Hip arthritis (symmetrical arthritis in hips) since 2017, Knee arthritis (symmetrical arthritis in both knees) since 2017, Back arthritis (symmetrical arthritis the back) since 2017 and Sulfonamide allergy (sulfa allergy manifested by itching and swelling). Concomitant products included TRAMADOL for Arthritis flare up, GABAPENTIN for Back pain, TRAZODONE for Sleeplessness.   In March 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) .4 milliliter every two weeks. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2020, the patient experienced JOINT SWELLING (Recurrent joint swelling), JOINT STIFFNESS (Recurrent joint stiffness), ARTHRALGIA (Recurrent joint pain) and PYREXIA (Recurrent low grade fever). On 14-Sep-2021, the patient experienced FATIGUE (Extreme fatigue), MYALGIA (Muscle aches) and PYREXIA (Fever). On an unknown date, the patient experienced STRESS (Stress). On 17-Sep-2021, FATIGUE (Extreme fatigue), MYALGIA (Muscle aches) and PYREXIA (Fever) had resolved. At the time of the report, JOINT SWELLING (Recurrent joint swelling), JOINT STIFFNESS (Recurrent joint stiffness), ARTHRALGIA (Recurrent joint pain) and PYREXIA (Recurrent low grade fever) had not resolved and STRESS (Stress) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Body temperature: 99-100.         The co-suspect drug Humira administered as a dose of 40 mg/0.4 ml in 14 days.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporters causality for the events of extreme fatigue, recurrent joint swelling, recurrent joint stiffness, fever, muscle aches, recurrent low grade fever and recurrent joint pain with Humira was reported as no reasonable possibility and for the event of stress was reported as not provided.  No treatment medications were reported.   Reporter did not allow further contact