Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Light chain analysis, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume
Clinical narrative: Polymyalgia rheumatica; Pain interfered with sleep; Pain in buttocks 2nd dose; pain in trapezius muscle 2nd dose; This spontaneous case was reported by a health care professional and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cervical spinal stenosis (The stenosis was treated) in November 2020, Arthritis of neck (The Arthritis neck was treated.) in November 2020 and Parathyroidectomy. Concurrent medical conditions included Latex allergy and Hypothyroidism since 07-Mar-2003. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 26-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 5:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced ARTHRALGIA (Pain in buttocks 2nd dose) and MYALGIA (pain in trapezius muscle 2nd dose). On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) (seriousness criterion medically significant). an unknown date, the patient experienced INSOMNIA (Pain interfered with sleep). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 200 milligram and PREDNISONE for Polymyalgia rheumatica, at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica), INSOMNIA (Pain interfered with sleep), ARTHRALGIA (Pain in buttocks 2nd dose) and MYALGIA (pain in trapezius muscle 2nd dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Basophil count: 0.05 (Inconclusive) The value was 0.05 10E3/uL (reference range: 0.01 to 0.08 10E3/uL). and 0.4 (normal) The value was 0.4 percent (reference range: 0.0 to 1.0 percent).. On 16-Apr-2021, Blood alkaline phosphatase: 127 (High) The value was 127 (high).. On 16-Apr-2021, C-reactive protein: 28.60 (High) The value was 28.60 (units was not mentioned).. On 16-Apr-2021, Eosinophil count: 0.15 (normal) The value was 0.15 10E3/uL (reference number: 0.03 to 0.51 10E3/uL). and 1.3 % (normal) The value was 1.3 percent (reference range: 1.0 to 9.0 percent).. On 16-Apr-2021, Haematocrit: 38.3 % (normal) The value was 38.3 percent (Reference range: 34.1 to 44.7 percent).. On 16-Apr-2021, Haemoglobin: 12.2 (normal) The value was 12.2 g/dL.. On 16-Apr-2021, Lymphocyte count: 11.4 (Low) The value was 11.4 percent (reference range: 18.0 to 51.0 percent). and 1.30 (Inconclusive) The value was 1.30 10E3/uL (reference range: 1.02 to 3.25 10E3/uL).. On 16-Apr-2021, Mean cell haemoglobin: 28.6 (normal) The value was 28.6 picogram (reference range: 23.5 to 32.6 picogram).. On 16-Apr-2021, Mean cell haemoglobin concentration: 31.9 (normal) The value was 31.9 g/dL (reference range: 31.4 to 35.2 g/dL).. On 16-Apr-2021, Mean cell volume: 90 (normal) The value was 90 fL (reference range: 76 to 98 fL).. On 16-Apr-2021, Monocyte count: 0.77 (Inconclusive) The value was 0.77 10E3/uL (Reference range: 0.23 to 0.70 10E3/uL). and 6.7 (normal) The value was 6.7 percent (reference range: 4.0 to 12.0 percent).. On 16-Apr-2021, Neutrophil count: 79.9 (High) The value was 79.9 percent (reference range: 37.0 to 73.0 percent). and 9.14 (High) The value was 9.14 10E3/uL (high) ( Reference range: 1.43 to 6.19 10E3/uL).. On 16-Apr-2021, Platelet count: 315 (normal) The value was 315 10E3/uL (Reference range was 158 to 384 10E3/uL).. On 16-Apr-2021, Red blood cell count: 4.27 (normal) The value was 4.27 10E6/uL (reference range: 3.67 to 5.15 10E6/uL).. On 16-Apr-2021, White blood cell count: 11.5 (High) The value of white blood cell count was 11.5 10E3/uL (Reference range: 3.3 to 9.4 10E3/uL).. On 12-May-2021, Albumin globulin ratio: 0.88 (Low) The value was 0.88 (low).. On 12-May-2021, Anion gap: 2 (Low) The value of Anion gap was 2mmol/L .. On 12-May-2021, C-reactive protein: 9.4 (High) The C-reactive protein value was 9.4 mg/L (reference range: 0.0 to 9.0 mg/L).. On 12-May-2021, Light chain analysis: 2.56 (High) The value was 2.56 mg/dL (Reference range: 0.33 to 1.94 mg/dL)., 1.74 (High) The value was 1.74 (high). and 1.47 (normal) The value was 1.47 mg/dL( Reference range: 0.57 to 2.63 mg/dL).. On 12-May-2021, Protein urine: 5.0 (Low) The value was 5.0 mg/dL..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other relevant concomitant medication included multiviamins. Treatment information included Acupuncture.  On 12-May-2021, the patient was referred to a rheumatologist with various x-rays and blood work.   On an unknown date, the patient was diagnosed with polymyalgia rheumatica. The pain interfered with patient's sleep.   On 15-May-2021, the patient underwent the following laboratory tests with no result. The laboratory tests were as follows: foot complete bilateral, hand bilateral, chest two view, wrist complete bilateral, glomerular filtration rate, creatinine comment, ana screen with reflex, component four complement, component three complement, comprehensive metabolic panel, c-reactive protein, creatine kinase, sedimentation rate and hepatitis C antibody.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up appended On 08-Jul-2021: Additional significant Follow-up was received on 08-Jul-2021: Patient details, suspect product details, medical history, event details and lab tests were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.