Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Shoulder issues/ Osteoarthritis in shoulders; Sore arm; Booster dose taken before completion of 5 months from Dose 2; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Shoulder issues/ Osteoarthritis in shoulders), PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose taken before completion of 5 months from Dose 2) in a 47-year-old male 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.    Concurrent medical conditions included Rheumatoid arthritis.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Daily dose: Citrate free, Solution for injection in pre-filled pen. In October 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose taken before completion of 5 months from Dose 2). On an unknown date, the patient experienced ARTHRITIS (Shoulder issues/ Osteoarthritis in shoulders) and PAIN IN EXTREMITY (Sore arm). At the time of the report, ARTHRITIS (Shoulder issues/ Osteoarthritis in shoulders), PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose taken before completion of 5 months from Dose 2) outcome was unknown.            Concomitant drugs were not reported.  It was unknown, if patient was enrolled in a COVID-19 vaccine trial.  Treatment medications were not provided.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is spontaneous case concerning an adult male patient with medical history of Rheumatoid arthritis, who experienced the unexpected, non-serious adverse event of special interest of Arthritis (Shoulder osteoarthritis), after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of Rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is spontaneous case concerning an adult male patient with medical history of Rheumatoid arthritis, who experienced the unexpected, non-serious adverse event of special interest of Arthritis (Shoulder osteoarthritis), after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of Rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.