Age: 76.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Drug interaction, Insomnia, Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: Hand swelling; Arthralgia aggravated; Joint range of motion decreased; Insomnia exacerbated; Stiffness; Humira was not working; Pain worsened; This spontaneous case was reported by a physician and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), INSOMNIA (Insomnia exacerbated), MUSCULOSKELETAL STIFFNESS (Stiffness), DRUG INTERACTION (Humira was not working) and PERIPHERAL SWELLING (Hand swelling) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus, Wrist pain (could not make a fist and uncomfortable driving) and Rheumatoid arthritis. Concomitant products included INSULIN DEGLUDEC (TRESIBA) for Diabetes, VALSARTAN for Hypertension, PREDNISONE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 mg. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), INSOMNIA (Insomnia exacerbated), MUSCULOSKELETAL STIFFNESS (Stiffness), DRUG INTERACTION (Humira was not working) and ARTHRALGIA (Arthralgia aggravated). In April 2021, the patient experienced PAIN (Pain worsened). On 25-May-2021, the patient experienced PERIPHERAL SWELLING (Hand swelling). The patient was treated with DICLOFENAC for Pain, at an unspecified dose and frequency. At the time of the report, JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), INSOMNIA (Insomnia exacerbated), MUSCULOSKELETAL STIFFNESS (Stiffness), DRUG INTERACTION (Humira was not working), PERIPHERAL SWELLING (Hand swelling), PAIN (Pain worsened) and ARTHRALGIA (Arthralgia aggravated) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), INSOMNIA (Insomnia exacerbated), MUSCULOSKELETAL STIFFNESS (Stiffness), DRUG INTERACTION (Humira was not working), PERIPHERAL SWELLING (Hand swelling), PAIN (Pain worsened) and ARTHRALGIA (Arthralgia aggravated) to be not related.    Some immunosuppressants drug such as Humira with been found to interact with COVID vaccines with subsequent reduction in product effectiveness for weather e drug or vaccine.  Hence, based on temporal association, causal association between the reported events and the product use cannot be excluded. Arthralgia is consistent with the product known safety profile.   Sender's Comments: Some immunosuppressants drug such as Humira with been found to interact with COVID vaccines with subsequent reduction in product effectiveness for weather e drug or vaccine.  Hence, based on temporal association, causal association between the reported events and the product use cannot be excluded. Arthralgia is consistent with the product known safety profile.