Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Fall, Tendon injury
Clinical narrative: Tripped and fell hurting right shoulder/Right shoulder injury; Arm bursitis/The patient tripped and fell hurting her right shoulder where she had bursitis; Left arm tendon injury as a small tear fissure; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Arm bursitis/The patient tripped and fell hurting her right shoulder where she had bursitis) and TENDON INJURY (Left arm tendon injury as a small tear fissure) in an adult 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) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis and Depression.   On 30-Mar-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2023, the patient experienced FALL (Tripped and fell hurting right shoulder/Right shoulder injury). In 2023, the patient experienced BURSITIS (Arm bursitis/The patient tripped and fell hurting her right shoulder where she had bursitis) (seriousness criterion medically significant) and TENDON INJURY (Left arm tendon injury as a small tear fissure) (seriousness criterion medically significant). The patient was treated with KETOROLAC at an unspecified dose and frequency and Surgery (Catheterization) for Bursitis. At the time of the report, BURSITIS (Arm bursitis/The patient tripped and fell hurting her right shoulder where she had bursitis), TENDON INJURY (Left arm tendon injury as a small tear fissure) and FALL (Tripped and fell hurting right shoulder/Right shoulder injury) had not resolved.            No concomitant medication information was reported.  The patient tripped and fell hurting her right shoulder where she had bursitis. The patient had left arm tendon injury described as a small tear fissure and received therapy treatment for bursitis and tendon fissure. Covid 19 vaccine caused unspecified affection on shoulders. Alternative etiology for shoulder injury was fall. Alternative etiology for shoulder affection was Covid 19 vaccine.  The reporter causality for the events of Arm bursitis, Catheterization, Covid 19 vaccine caused unspecified affection on shoulders, Left arm tendon injury as a small tear fissure, Tripped and fell hurting right shoulder/Right shoulder injury with Adalimumab Solution for Injection was no reasonable possibility. Agency's opinion was that the causality for the events of Arm bursitis, Catheterization, Covid 19 vaccine caused unspecified affection on shoulders, Left arm tendon injury as a small tear fissure, Tripped and fell hurting right shoulder/Right shoulder injury with MRNA 1273 (Elasomeran) was not provided Agency's opinion was that the causality for the events of Arm bursitis, Catheterization, Covid 19 vaccine caused unspecified affection on shoulders, Left arm tendon injury as a small tear fissure, Tripped and fell hurting right shoulder/Right shoulder injury with Adalimumab Solution for Injection was no reasonable possibility. Company Comment: This spontaneous case concerns an adult female patient with relevant medical history of Rheumatoid arthritis treated with Adalimumab (Humira), who experienced the serious, medically significant, unexpected events of Bursitis and tendon injury and the non-serious event of fall. The event onset date and vaccination date were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. The patient received the 2 primary doses and the third dose of mRNA-1273. It was reported that the patient tripped and fell hurting her right shoulder where she had bursitis. She had left arm tendon injury described as a small tear fissure. She received therapy treatment for bursitis and tendon fissure. Catheterization as medical procedure was also performed. No further clinical information was provided for medical review. Bursitis and tendon injury were considered as a result of fall, and fall was due to that the patient tripped, so assessed as not related. The medical history of Rheumatoid arthritis could be a confounder for Bursitis and tendon injury. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient with relevant medical history of Rheumatoid arthritis treated with Adalimumab (Humira), who experienced the serious, medically significant, unexpected events of Bursitis and tendon injury and the non-serious event of fall. The event onset date and vaccination date were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. The patient received the 2 primary doses and the third dose of mRNA-1273. It was reported that the patient tripped and fell hurting her right shoulder where she had bursitis. She had left arm tendon injury described as a small tear fissure. She received therapy treatment for bursitis and tendon fissure. Catheterization as medical procedure was also performed. No further clinical information was provided for medical review. Bursitis and tendon injury were considered as a result of fall, and fall was due to that the patient tripped, so assessed as not related. The medical history of Rheumatoid arthritis could be a confounder for Bursitis and tendon injury. The benefit-risk relationship of mRNA-1273 is not affected by this report.