Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Polymyalgia rheumatica
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia Rheumatica) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dairy intolerance, Drug allergy (allergic to Compazine), Hay fever since 1976, Osteopenia since 2000, Tinnitus since 2016 and Osteoarthritis since 1990. Concomitant products included MACROGOL 400 (BLINK TEARS) for Dry eye, VITAMINS NOS (MULTIPLE VITAMIN) for Multi-vitamin maintenance, VITAMIN D3, PROBIOTICS NOS, FISH OIL and HOMOCYSTEINE THIOLACTONE HYDROCHLORIDE for Routine health maintenance, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 01-Jan-2020 to an unknown date and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Sinusitis, MAGNESIUM CITRATE for an unknown indication, GLUCOSAMINE & CHONDORITIN. On 22-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced ARTHRALGIA (severe leg pain (both)/Pain seemed to concentrate in back of legs/intense pain in joints and muscles of the legs). On 21-Apr-2021, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia Rheumatica) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST DISCOMFORT (tightness in the chest). At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia Rheumatica) and ARTHRALGIA (severe leg pain (both)/Pain seemed to concentrate in back of legs/intense pain in joints and muscles of the legs) had not resolved and CHEST DISCOMFORT (tightness in the chest) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Additional concomitant medication taken at the start of the events included OsteoThera 4 times per day. On 27-Jan-2021, the patient experienced intense pain in the joints and muscles of the legs. She applied ice as treatment. Over the next 2-3 weeks pain moved to other joints and muscles with varied intensity; fatigue and weakness noted. Overtime it became very difficult for the patient to stand up from a seated position, walk, turn over when lying down, or bend over to sit down. On 09-Feb-2021 additional daily supplements were started: Pea Protein, Calcium D-Glucarate, Digestive Enzymes (Digest Gold), GI Motility Complex, Glutagenics Powder, Sun Fiber. The patient sought medical attention from her Primary Care Provider (PCP). The patient's ESR and CRP were elevated, indicative of an inflammatory condition. The patient was referred to Rheumatology. While she waited 5 weeks for the appointment, she experienced tightness in the chest and continued loss of function. She eventually went to the Emergency Room (ER) and 1 lab result was slightly elevated, indicative of Lyme disease. The ER doctor administered ketorolac and iodixanol and the patient started treatment with doxycycline. On 21-Apr-2021, doxycycline was stopped as additional lab tests for Lyme disease were normal. The patient was diagnosed with Polymyalgia Rheumatica and started treatment with Prednisone 15 mg daily (gradual tapering off was planned), heat, light stretching, and exercise to regain leg movement. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Additional initial received on 12-May-2021. Concomitant medication added; event added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.