Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Chills, Lower limb fracture, Nausea, Upper limb fracture
Clinical narrative: Chills; Nausea; BROKE ARM DUE TO ARTHRITIS; BROKE LEG DUE TO ARTHRITIS; Arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis), UPPER LIMB FRACTURE (BROKE ARM DUE TO ARTHRITIS) and LOWER LIMB FRACTURE (BROKE LEG DUE TO ARTHRITIS) in a 61-year-old 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) injection for Rheumatoid arthritis.    The patient's past medical history included Arm operation in 2019. Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2019, the patient experienced ARTHRITIS (Arthritis) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (Chills), NAUSEA (Nausea), UPPER LIMB FRACTURE (BROKE ARM DUE TO ARTHRITIS) (seriousness criterion medically significant) and LOWER LIMB FRACTURE (BROKE LEG DUE TO ARTHRITIS) (seriousness criterion medically significant). At the time of the report, CHILLS (Chills), ARTHRITIS (Arthritis), NAUSEA (Nausea), UPPER LIMB FRACTURE (BROKE ARM DUE TO ARTHRITIS) and LOWER LIMB FRACTURE (BROKE LEG DUE TO ARTHRITIS) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.  No concomitant medication information was  provided.  It was reported that patient  had surgery on broken arm that was broken in 2019 due to arthritis.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information was provided.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 61-year-old female patient, with relevant current condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) of Arthritis, which occurred prior to vaccination with an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed or treatments received. At the time of the report the event had resolved. Underlying rheumatoid arthritis could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 61-year-old female patient, with relevant current condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) of Arthritis, which occurred prior to vaccination with an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed or treatments received. At the time of the report the event had resolved. Underlying rheumatoid arthritis could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.