Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Polymyalgia rheumatica, Product dose omission issue, Red blood cell sedimentation rate
Clinical narrative: Left leg is giving me some problems, the muscle is weak; My left arm is still sore; I haven't had the 2nd dose; diagnosed with PMR, general muscle soreness/muscle pain-really sore; Difficulty getting out of a chair/ difficulty dressing myself/ difficulty getting jackets on; Had difficulty walking; didn't have the strength to pull myself up; I had a AVR reaction; soreness in arm at the injection site; General muscle soreness/I was feeling muscle pain - really sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POLYMYALGIA RHEUMATICA (diagnosed with PMR, general muscle soreness/muscle pain-really sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced MYALGIA (General muscle soreness/I was feeling muscle pain - really sore) and VACCINATION SITE PAIN (soreness in arm at the injection site). On 09-Mar-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Difficulty getting out of a chair/ difficulty dressing myself/ difficulty getting jackets on), GAIT DISTURBANCE (Had difficulty walking), ASTHENIA (didn't have the strength to pull myself up) and VACCINATION COMPLICATION (I had a AVR reaction). On 22-Mar-2021, the patient experienced POLYMYALGIA RHEUMATICA (diagnosed with PMR, general muscle soreness/muscle pain-really sore) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Left leg is giving me some problems, the muscle is weak), PAIN IN EXTREMITY (My left arm is still sore) and PRODUCT DOSE OMISSION ISSUE (I haven't had the 2nd dose). The patient was treated with PREDNISONE for Polymyalgia rheumatica, at a dose of 15 mg; PREDNISONE for Polymyalgia rheumatica, at a dose of 5 mg and PREDNISONE for Polymyalgia rheumatica, at a dose of 2.5 mg. At the time of the report, POLYMYALGIA RHEUMATICA (diagnosed with PMR, general muscle soreness/muscle pain-really sore), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Difficulty getting out of a chair/ difficulty dressing myself/ difficulty getting jackets on), MUSCULAR WEAKNESS (Left leg is giving me some problems, the muscle is weak) and PAIN IN EXTREMITY (My left arm is still sore) had not resolved, GAIT DISTURBANCE (Had difficulty walking), ASTHENIA (didn't have the strength to pull myself up), MYALGIA (General muscle soreness/I was feeling muscle pain - really sore), VACCINATION COMPLICATION (I had a AVR reaction) and VACCINATION SITE PAIN (soreness in arm at the injection site) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (I haven't had the 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Blood creatine phosphokinase: 56 (normal) 56. On 22-Mar-2021, Blood creatinine: 1.01 (normal) 1.01. On 22-Mar-2021, Blood glucose: 114 (normal) 114. On 22-Mar-2021, Blood thyroid stimulating hormone: 2.06 (normal) 2.06. On 22-Mar-2021, C-reactive protein: 28 (abnormal) 28. On 22-Mar-2021, Glycosylated haemoglobin: 6.7 (abnormal) 6.7. On 22-Mar-2021, Red blood cell sedimentation rate: 32 (abnormal) 32.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were reported.  The patient was perfectly fine before the shot and was walking 3-4 miles/day. On 02-MAR-2021, she had soreness in her arm at the injection site and general muscle soreness. On 09-Mar-2021, the patient reported having an "AVR" reaction. She had difficulty walking, getting out of a chair, and difficulty dressing herself. She was feeling muscle pain - really sore. All of her extremities were affected. On 22-Mar-2021, the patient visited her primary care provider and was diagnosed with PMR (polymyalgia rheumatica). Labs also included: CMP (comprehensive metabolic panel), CBC (complete blood cell count), and lipid panel were performed (results not provided). The patient was prescribed Prednisone 15 mg, but couldn't tolerate it, so the dose was reduced to 5 mg and then 2.5 mg.  Company comment: This is a case of Product dose omission issue for this70-year-old, female patient with no reported relevant medical history, who experienced the serious unexpected event of Polymyalgia Rheumatica. The event occurred 20 days day after the first dose of Spikevax. The rechallenge was unknown for the event, as there is only information available about the first dose.  The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This is a case of Product dose omission issue for this70-year-old, female patient with no reported relevant medical history, who experienced the serious unexpected event of Polymyalgia Rheumatica. The event occurred 20 days day after the first dose of Spikevax. The rechallenge was unknown for the event, as there is only information available about the first dose.  The benefit-risk relationship of Spikevax is not affected by this report.