Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Sjogren's syndrome, Vaccination site pain
Clinical narrative: osteoarthritis; Sjögren's syndrome; pain in my arm and the site where the injection was given; Muscle pain; pain in my arm and the site where the injection was given; Grade C2 osteoporosis; joint pain; This spontaneous case was reported by a patient and describes the occurrence of OSTEOARTHRITIS (osteoarthritis) and SJOGREN'S SYNDROME (Sjögren's syndrome) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OSTEOARTHRITIS (osteoarthritis) (seriousness criterion medically significant), SJOGREN'S SYNDROME (Sjögren's syndrome) (seriousness criterion medically significant), PAIN IN EXTREMITY (pain in my arm and the site where the injection was given), MYALGIA (Muscle pain), VACCINATION SITE PAIN (pain in my arm and the site where the injection was given), OSTEOPOROSIS (Grade C2 osteoporosis) and ARTHRALGIA (joint pain). The patient was treated with PREDNISOLONE at a dose of 5 milligram once a day and METHOTREXATE at an unspecified dose and frequency. At the time of the report, OSTEOARTHRITIS (osteoarthritis), SJOGREN'S SYNDROME (Sjögren's syndrome), PAIN IN EXTREMITY (pain in my arm and the site where the injection was given), MYALGIA (Muscle pain), VACCINATION SITE PAIN (pain in my arm and the site where the injection was given), OSTEOPOROSIS (Grade C2 osteoporosis) and ARTHRALGIA (joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. The patient had Moderna vaccination on 21-MAY-2021, he experienced significant side effects, including severe, persistent pain in the arm and injection site, along with joint and muscle discomfort. He has possible osteoarthritis or Sjogren's syndrome and has been diagnosed with grade C2 osteoporosis attributed to long-term prednisolone use. The pain was most intense at night and in the early morning, improving with daytime movement. Over the past few years, the pain exhibited a cyclical pattern, with increasingly severe episodes lasting several weeks, accompanied by additional joint and muscle pain. Despite consultations with various specialists, there had been little focus on treating the suspected osteoarthritis or Sjogren's syndrome, and laboratory tests returned normal results. He was on prednisolone and methotrexate for several years, with prednisolone (5mg/day) effectively alleviating pain and restoring mobility, though it was contributed to his osteoporosis, which now requires treatment. After gradually tapering off the medications, the pain returned, varying in intensity. He seeks information on whether similar cases have been reported and requests guidance on managing these debilitating, long-term side effects.  Company Comment- This spontaneous case concerns a 66-year-old, male patient with no medical history reported, who experienced the unexpected serious (medically significant) events osteoarthritis and Sjogren´s syndrome after a dose of mRNA-1273 vaccine was administered (doe number was not provided). It was reported that since vaccination patient has been experiencing severe, persistent, and recurring pain in his arm and the site where the injection was given. This pain has been most severe during the night and early morning and improved with movement during the day. Over the last few years, this pain has followed a cyclical pattern, with increasingly intense episodes that lasted several weeks, coinciding with other symptoms of pain in joints and muscles. Patient has consulted several specialists, who have not focused their efforts on the treatment of probable osteoarthritis or Sjögren's syndrome, although the diagnosis has not yet been confirmed, since the results of laboratory tests were within normal limits. He has been treated with prednisolone and methotrexate for several years. Prednisolone (5mg/day) indeed reduced or eliminated pain and other symptoms and restored his mobility, but it has led patient to a state of grade C2 Osteoporosis, which now must be treated. After the process of gradual suspension of the medications, the pain has returned, in the same way, very strong, disabling, on some days and on some others milder. The outcome of the events was reported as not recovered. Causality for event osteoporosis was assessed as not related as it was secondary to treatment with prednisolone. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.