Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Shoulder operation, Vaccination site pain
Clinical narrative: Shoulder operation; Hemorrhoids; Arthritis; Pulled muscle; Vaccination site pain; Pain localised; Joint range of motion decreased; Breathing difficult; This spontaneous case was reported by a consumer and describes the occurrence of SHOULDER OPERATION (Shoulder operation) in a 78-year-old male 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) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced DYSPNOEA (Breathing difficult), JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), VACCINATION SITE PAIN (Vaccination site pain) and PAIN (Pain localised). On an unknown date, the patient experienced SHOULDER OPERATION (Shoulder operation) (seriousness criterion medically significant), HAEMORRHOIDS (Hemorrhoids), ARTHRITIS (Arthritis) and MUSCLE STRAIN (Pulled muscle). At the time of the report, SHOULDER OPERATION (Shoulder operation) and MUSCLE STRAIN (Pulled muscle) had resolved and HAEMORRHOIDS (Hemorrhoids), DYSPNOEA (Breathing difficult), ARTHRITIS (Arthritis), JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), VACCINATION SITE PAIN (Vaccination site pain) and PAIN (Pain localised) outcome was unknown.            The patient had second dose of Moderna Covid-19 vaccine on 12 Feb 2021 and third dose Moderna vaccine on 14 Aug 2021. It was unknown if patient was enrolled in a covid-19 vaccine trial.  No Treatment Drug was provided by reporter.  Company comment: This is a spontaneous case concerning a 78-year-old, male patient with relevant concurrent medical condition of rheumatoid arthritis. The patient has co-suspect medication of Adalimumab (Humira) for rheumatoid arthritis with unspecified therapy dates. The patient experienced the unexpected serious (medically significant) event of shoulder operation, the unexpected non-serious AESI event of arthritis, the unexpected non-serious events of muscle strain, hemorrhoids, joint range of motion decreased, dyspnea and pain, and the expected non-serious event of vaccination site pain. The patient received first and second dose of mRNA-1273 vaccine with 29 days dosage interval. Approximately 183 days after the second dose, the patient received third dose of mRNA-1273. The events, pain, joint range of motion decreased, dyspnoea and vaccination site pain occurred on the same year with the first dose of mRNA-1273 vaccine administration. The rest of the other events occurrence unknown with respect to the first dose of mRNA-1273 vaccine. No further clinical information was available for medical review. The outcome of the events shoulder operation and muscle strain was reported as resolved, the rest of the other events the outcome was reported as unknown. The concurrent medical condition of rheumatoid arthritis remain confounder for the event arthritis. The co-suspect medication of Adalimumab (Humira) remain confounder for the event dyspnoea. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 78-year-old, male patient with relevant concurrent medical condition of rheumatoid arthritis. The patient has co-suspect medication of Adalimumab (Humira) for rheumatoid arthritis with unspecified therapy dates. The patient experienced the unexpected serious (medically significant) event of shoulder operation, the unexpected non-serious AESI event of arthritis, the unexpected non-serious events of muscle strain, hemorrhoids, joint range of motion decreased, dyspnea and pain, and the expected non-serious event of vaccination site pain. The patient received first and second dose of mRNA-1273 vaccine with 29 days dosage interval. Approximately 183 days after the second dose, the patient received third dose of mRNA-1273. The events, pain, joint range of motion decreased, dyspnoea and vaccination site pain occurred on the same year with the first dose of mRNA-1273 vaccine administration. The rest of the other events occurrence unknown with respect to the first dose of mRNA-1273 vaccine. No further clinical information was available for medical review. The outcome of the events shoulder operation and muscle strain was reported as resolved, the rest of the other events the outcome was reported as unknown. The concurrent medical condition of rheumatoid arthritis remain confounder for the event arthritis. The co-suspect medication of Adalimumab (Humira) remain confounder for the event dyspnoea. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.