Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood chloride, Blood creatinine
Clinical narrative: Chills after the 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills after the 3rd dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 012L20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement on 27-Apr-2021. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE, ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) and ETANERCEPT (ENBREL) for Rheumatoid arthritis, UPADACITINIB (RINVOQ) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills after the 3rd dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 22-Sep-2021, CHILLS (Chills after the 3rd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Oct-2021, Alanine aminotransferase (0-32): 22 (normal) 22 IU/L -normal. On 15-Oct-2021, Albumin globulin ratio (1.2-2.2): 1.6 (normal) 1.6 - normal. On 15-Oct-2021, Aspartate aminotransferase (0-40): 22 (normal) 22 IU/L - Normal. On 15-Oct-2021, Basophil count: 0.1×10e3/ul (normal) 0.1×10E3/uL - normal  Normal range- 0 to 0×10E3/uL. On 15-Oct-2021, Blood albumin (3.8-4.8): 4.5 (normal) 4.5 g/dL -normal. On 15-Oct-2021, Blood alkaline phosphatase (44-121): 81 (normal) 81 IU/L - Normal. On 15-Oct-2021, Blood bilirubin (0.0-1.2): 0.3 (normal) 0.3 mg/dL -Normal. On 15-Oct-2021, Blood calcium (8.7-10.3): 10.2 (normal) 10.2 mg/dL -Normal. On 15-Oct-2021, Blood chloride (96-106): 103 (normal) 103 mmol/L -normal. On 15-Oct-2021, Blood creatinine (0.57-1.00): 0.83 (normal) 0.83 mg/dL. On 15-Oct-2021, Blood glucose (65-99): 92 mg/dl (normal) 92 mg/dL-Normal. On 15-Oct-2021, Blood potassium (3.5-5.2): 5.5 (High) 5.5 mmol/L -High. On 15-Oct-2021, Blood urea (8-27): 9 mg/dl (normal) 9 mg/dL-Normal. On 15-Oct-2021, Blood urea nitrogen/creatinine ratio (12-28): 11 (Low) Decreased. On 15-Oct-2021, C-reactive protein (0.0-10.0): 9 mg/l (normal) 9mg/L - Normal. On 15-Oct-2021, Carbon dioxide (8.7-10.3): 10.2 (normal) 10.2 mg/dL -Normal. On 15-Oct-2021, Eosinophil count: 0.3×10e3/ul (normal) 0.3×10E3/uL- normal  Normal range is 0×10E3/uL. On 15-Oct-2021, Globulin (1.5-4.5): 2.9 (normal) 2.9 g/dL -Normal. On 15-Oct-2021, Glomerular filtration rate: 72 (High) 72 mL/min/1.73   Normal range is > 59mL/min/1.73. On 15-Oct-2021, Haematocrit (34-46): 38.4 (normal) 38.4%- Normal. On 15-Oct-2021, Haemoglobin (11.1-15.9): 12.6 (normal) 12.6 g/dL -Normal. On 15-Oct-2021, Hepatitis B surface antibody: non reactive (Negative) Non reactive - inconsistent with immunity, less than 10mlU/ml.. On 15-Oct-2021, Hepatitis B surface antigen: negative (Negative) negative. On 15-Oct-2021, Hepatitis C antibody (0.0-0.9): <0.1 (normal) <0.1 s/co ratio. On 15-Oct-2021, Hepatitis C virus test: negative (Negative) Negative. On 15-Oct-2021, Immature granulocyte count (0.0-0.1): 0.0×10e3/ul (normal) 0.0×10E3/uL- normal. On 15-Oct-2021, Lymphocyte count: 1.5×10e3/ul (normal) 1.5×10E3/uL -Normal  Normal range is 0-3×10E3/uL. On 15-Oct-2021, Mean cell haemoglobin (26.6-33.0): 31.7 (normal) 31.7 pg-  normal. On 15-Oct-2021, Mean cell haemoglobin concentration (31-35): 32.8 (normal) 32.8 g/dL- normal. On 15-Oct-2021, Mean cell volume (79.0-97.0): 97 (normal) 97 fL - normal. On 15-Oct-2021, Monocyte count: 0.7×10e3/ul (normal) 0.7×10E3/uL- normal  Normal range is 0-0×10E3/uL. On 15-Oct-2021, Neutrophil count: 3.5×10e3/ul (normal) 3.5×10E3/uL  Normal range is 1-7×10E3/uL. On 15-Oct-2021, Platelet count: 373×10e3/ul (normal) 373×10E3/uL  Normal range is 150-450×10E3/uL. On 15-Oct-2021, Protein total (6.0-8.5): 7.4 (normal) 7.4 g/dL - normal. On 15-Oct-2021, Red blood cell count: 3.98×10 (normal) 3.98×10E6/uL -Normal  Normal range is 3.77-5.28×10E3/uL. On 15-Oct-2021, Red blood cell sedimentation rate normal (0-40): 8 (normal) 8 mm/hr - Normal. On 15-Oct-2021, SARS-CoV-2 antibody test: positive (Positive) >25000.0 U/mL, Positive. On 15-Oct-2021, Tuberculosis: negative (Negative) Negative. On 15-Oct-2021, White blood cell count: 6.0×10 e3/ul (normal) 6.0×10 E3/uL -normal  Normal range is 3.4-10.8×10E3/uL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reported in a F/U , patient stated that she had positive effect of Moderna COVID-19 vaccination on RHEUMATOID ARTHRITIS as she have been able to discontinue weekly injection of 100cc of methotrexate and a daily Rinvoc tablet and controlling her pain level with Advil and/or Aleve with an occasional Tylenol. Other lab data includes on 15-Oct-2021  Quantiferon Tb Ag 0.12IU/mL, Quantiferon Tb2 Ag value is 0.07IU/mL,  Quantiferon Nil value 0.06 IU/mL,  Quantiferon mitogen value 7.77 IU/mL,  Quantieron TB gold was negative. GFRMDRD Non Af Amer (> 59 mL/min/1.73) : 72ml/min/1.73: (normal)  GFRMDRD Af Amer (> 59 mL/min/1.73) : 83 ml/min/1.73: (normal) neutrophils relative 58% lymphocytes relative 25% monocytes relative 12% eosinophils relative 4% basophils relative 1%  immature granulocytes 0%   This case was linked to MOD-2021-232463 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Source document contains no new information. On 21-Oct-2021: Captured all the lab details into lab data as well as I-narrative supplement.