Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fibromyalgia, Finger deformity, Hepatic steatosis, Immunisation reaction
Clinical narrative: Progression of rheumatoid arthritis; Inflammation/ Inflammation progression; Swelling; Bone pain; Hand swelling; Fatty liver; Finger deformity; Weight gain; Vaccination adverse reaction; Fibromyalgia; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Progression of rheumatoid arthritis) in an adult female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Kidney stones in 1991, Lithotripsy in 2017 and Lithotripsy in September 2019. Previously administered products included for Drug use for unknown indication: IODINE and ANCEF. Past adverse reactions to the above products included No adverse event with ANCEF and IODINE. Concurrent medical conditions included Fatty liver since 2019, Rheumatoid arthritis, Iodine allergy (Iodine Allergy Manifested By Generalized Body Hives) and Drug allergy (Cefazolin Allergy Manifested By Asphyxia). Concomitant products included AMITRIPTYLINE HYDROCHLORIDE (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) for Fibromyalgia, ERENUMAB (AIMOVIG [ERENUMAB]) from October 2020 to an unknown date for Headache.   In October 2019, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 12-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In April 2020, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). In 2020, the patient experienced FIBROMYALGIA (Fibromyalgia). In December 2020, the patient experienced WEIGHT INCREASED (Weight gain). In January 2021, the patient experienced FINGER DEFORMITY (Finger deformity). In March 2021, the patient experienced HEPATIC STEATOSIS (Fatty liver). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Progression of rheumatoid arthritis) (seriousness criterion medically significant), INFLAMMATION (Inflammation/ Inflammation progression), SWELLING (Swelling), BONE PAIN (Bone pain) and PERIPHERAL SWELLING (Hand swelling). At the time of the report, RHEUMATOID ARTHRITIS (Progression of rheumatoid arthritis), FINGER DEFORMITY (Finger deformity), INFLAMMATION (Inflammation/ Inflammation progression), FIBROMYALGIA (Fibromyalgia) and BONE PAIN (Bone pain) had not resolved, WEIGHT INCREASED (Weight gain), SWELLING (Swelling) and PERIPHERAL SWELLING (Hand swelling) outcome was unknown and HEPATIC STEATOSIS (Fatty liver) and IMMUNISATION REACTION (Vaccination adverse reaction) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Weight: Weight gained.   mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosing remained unchanged.   No treatment medication details were provided.  Formulation for HUMIRA 40MG/0.8ML was given as Solution for injection in pre-filled pen.  The reporter's causality for the events of finger deformity, inflammation, hepatic steatosis, fibromyalgia, bone pain, rheumatoid arthritis with HUMIRA was no reasonable possibility. The reporter's causality for the event of weight gain with HUMIRA was a reasonable possibility. The reporter's causality of other events was not provided.  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.   This case was linked to MOD-2021-623965 (Patient Link).