Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Bone density decreased, C-reactive protein, Cardiac discomfort, Chest discomfort, Fine motor skill dysfunction
Clinical narrative: Stiffness all over; Couldn't sleep; Treated as though he has Polymyalgia Rheumatica; Lost weight; Body was pulsating; Muscle ache; Injection site itchy; pain radiating down pelvis, legs, thighs, feet, toes; Systemic body inflammation/bad case of inflammation; Immune system compromised; Poor sleep; Chest congestion; Bone weakness; Loss dexterity in fingers cannot attach garden hose; Pressure heart pain after walking; Muscle stiffness/stiffness all over/Consumer couldn't sleep, was waking up stiff; Muscle weakness; Pain at injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of POLYMYALGIA RHEUMATICA (Treated as though he has Polymyalgia Rheumatica) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Broken ankle in 2017. Concurrent medical conditions included Neck pain since 2018, Shoulder pain since 2018, Chronic arthritis and Diabetes.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 27-Feb-2021, the patient experienced IMMUNE SYSTEM DISORDER (Immune system compromised), POOR QUALITY SLEEP (Poor sleep), CHEST DISCOMFORT (Chest congestion), BONE DENSITY DECREASED (Bone weakness), FINE MOTOR SKILL DYSFUNCTION (Loss dexterity in fingers cannot attach garden hose), CARDIAC DISCOMFORT (Pressure heart pain after walking), MUSCULOSKELETAL STIFFNESS (Muscle stiffness/stiffness all over/Consumer couldn't sleep, was waking up stiff), MUSCULAR WEAKNESS (Muscle weakness), PAIN IN EXTREMITY (pain radiating down pelvis, legs, thighs, feet, toes), INFLAMMATION (Systemic body inflammation/bad case of inflammation), MYALGIA (Muscle ache) and VACCINATION SITE PRURITUS (Injection site itchy). On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Treated as though he has Polymyalgia Rheumatica) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Stiffness all over), INSOMNIA (Couldn't sleep) and PALPITATIONS (Body was pulsating). The patient was treated with MELOXICAM at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form and Physical therapy for Polymyalgia rheumatica. At the time of the report, POLYMYALGIA RHEUMATICA (Treated as though he has Polymyalgia Rheumatica), IMMUNE SYSTEM DISORDER (Immune system compromised), MUSCULOSKELETAL STIFFNESS (Stiffness all over), INSOMNIA (Couldn't sleep), POOR QUALITY SLEEP (Poor sleep), CHEST DISCOMFORT (Chest congestion), BONE DENSITY DECREASED (Bone weakness), FINE MOTOR SKILL DYSFUNCTION (Loss dexterity in fingers cannot attach garden hose), CARDIAC DISCOMFORT (Pressure heart pain after walking), MUSCULOSKELETAL STIFFNESS (Muscle stiffness/stiffness all over/Consumer couldn't sleep, was waking up stiff), MUSCULAR WEAKNESS (Muscle weakness), PAIN IN EXTREMITY (pain radiating down pelvis, legs, thighs, feet, toes), INFLAMMATION (Systemic body inflammation/bad case of inflammation), PALPITATIONS (Body was pulsating), MYALGIA (Muscle ache), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE PRURITUS (Injection site itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, C-reactive protein: 17.2 (abnormal) Polymyalgia Rheumatica..         Treatment included non-specific "steroids."   A 66 Y/O M developed serious unexpected polymyalgia rheumatica, and NS immune system disorder, musculoskeletal stiffness, insomnia, poor quality sleep, chest discomfort, bone density decreased, fine motor skill dysfunction, cardiac discomfort, muscular weakness, pain in extremity, inflammation, palpitations and other expected events. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: The follow up document was added and Treatment medications, lab data, events were updated.; Sender's Comments: A 66 Y/O M developed serious unexpected polymyalgia rheumatica, and NS immune system disorder, musculoskeletal stiffness, insomnia, poor quality sleep, chest discomfort, bone density decreased, fine motor skill dysfunction, cardiac discomfort, muscular weakness, pain in extremity, inflammation, palpitations and other expected events. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.