Sex: F
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome, Drug ineffective, Injection site pain, Rheumatoid arthritis, Therapeutic response shortened
Clinical narrative: Carpal tunnel syndrome; Wearing off effect; Lack of drug effect; Injection site burning; Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), DRUG INEFFECTIVE (Lack of drug effect), INJECTION SITE PAIN (Injection site burning) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Carpal tunnel release in August 2022. Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome) (seriousness criterion medically significant), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) (seriousness criterion medically significant), DRUG INEFFECTIVE (Lack of drug effect) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site burning) (seriousness criterion medically significant) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome), DRUG INEFFECTIVE (Lack of drug effect), INJECTION SITE PAIN (Injection site burning) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) outcome was unknown and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) was resolving.            No concomitant medication information provided On unknown date, the patient experienced carpal tunnel syndrome wear off before next Humira injection within a few days medicines wearing off lots of pain by the time for next injection. Humira seemed to not be working, injection burned and rheumatoid arthritis flare up. Moderna covid-19 vaccine (Elasomeran) was also considered suspect. The patient had carpel tunnel surgery scheduled on Aug-2022. Humira was not working and within a few days medication wearing off. The patient had lots of pain by the time for next injection. The patient's last injection was fine and did not burn but time before last injection burned. The second dose of COVID vaccine caused her rheumatoid arthritis flares. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of carpal tunnel syndrome, Humira seemed to not be working. Injection burned and rheumatoid arthritis flare up was not provided. The reporter causality for the events of wear off before next Humira injection within a few days medicines wearing off lots of pain by the time for next injection with Humira (adalimumab) was a reasonable possibility. AbbVie opinion was that there was no reasonable possibility that the events of carpal tunnel syndrome, wear off before next Humira injection within a few days medicines wearing off lots of pain by the time for next injection. The Humira seems to not be working and rheumatoid arthritis flare up was related to Humira (adalimumab). AbbVie opinion was that there was a reasonable possibility that the event of injection burned was related to Humira (adalimumab). No treatment medication information provided Company comment: This spontaneous case concerns an adult female patient (age not specified), with a medical history Rheumatoid arthritis treated with co-suspect drug Adalimumab, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) and unexpected serious (medically significant) events of Carpal tunnel syndrome, Therapeutic response shortened and Injection site pain that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Additionally Drug ineffective is also reported in this case. The patient had carpel tunnel surgery scheduled in Aug 2022. The outcome of event Therapeutic response shortened was reported as resolving and the other events were reported as unknown. Patients medical history of Rheumatoid arthritis could be a confounder for the event Rheumatoid arthritis since this disease can have flares. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness was assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns an adult female patient (age not specified), with a medical history Rheumatoid arthritis treated with co-suspect drug Adalimumab, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) and unexpected serious (medically significant) events of Carpal tunnel syndrome, Therapeutic response shortened and Injection site pain that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Additionally Drug ineffective is also reported in this case. The patient had carpel tunnel surgery scheduled in Aug 2022. The outcome of event Therapeutic response shortened was reported as resolving and the other events were reported as unknown. Patients medical history of Rheumatoid arthritis could be a confounder for the event Rheumatoid arthritis since this disease can have flares. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness was assessed based on medical judgement.