Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Polymyalgia rheumatica, Pyrexia, Weight increased
Clinical narrative: gained 30 lbs.; polymyalgia rheumatica; 102 F Fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (polymyalgia rheumatica) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Food allergy (Patient cannot tolerate tomatoes (stomach upset)).   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced PYREXIA (102 F Fever) and NAUSEA (nausea). In March 2021, the patient experienced POLYMYALGIA RHEUMATICA (polymyalgia rheumatica) (seriousness criterion medically significant). On an unknown date, the patient experienced WEIGHT INCREASED (gained 30 lbs.). At the time of the report, POLYMYALGIA RHEUMATICA (polymyalgia rheumatica), WEIGHT INCREASED (gained 30 lbs.), PYREXIA (102 F Fever) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The patient had a severe stiff neck, groin pain, and pain in arms, knees and shoulders 5 days later after receiving the second dose. All these were the symptoms of polymyalgia rheumatica. She reported that she went to see a physician and was diagnosed with polymyalgia rheumatica in Mar-2021. The patient was prescribed steroids and was taking them since Mar-2021. She reported that she has gained 30 pounds (lbs) from the steroids. Patient stated that she was healthy and going to gym prior to receiving Moderna vaccines. Patient's rheumatologist was running tests and blood work. She mentioned this autoimmune disorder was a debilitating disorder.  The reporter stated that the steroids had helped but she still had pain in her shoulders and arms.    Company Comment: This is a spontaneous case concerning a 59-year-old female patient with no relevant medical history, who experienced the serious unexpected event Polymyalgia rheumatica. The events occurred more than a month after the second dose of mRNA-1273 Moderna vaccine. Patient reports that started with symptoms (pain in arms, groin, knees, shoulders and stiff neck) a few days after second dose and was diagnosed polymyalgia in March, when she started treatment with steroids. Female gender could be a confounder for the event. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 59-year-old female patient with no relevant medical history, who experienced the serious  unexpected event Polymyalgia rheumatica. The events occurred more than a month after the second  dose of mRNA-1273 Moderna vaccine.  Patient reports that started with symptoms (pain in arms, groin, knees, shoulders and stiff neck) a few days after second dose and was diagnosed  polymyalgia in March, when she started treatment with steroids. Female gender could be a confounder for the event. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.