Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Hypoxia, Oxygen saturation decreased, Platelet count, Pneumonitis
Clinical narrative: Atypical pneumonia; Patient admitted with atypical pneumonia/pneumonitis; Bronchospasm; Initial SaO2 values to be in the low to mid 80% range; Cough; Hypoxia; Increasing shortness of breath; This case was received via  FDA VAERS (Reference number: 1106702) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ATYPICAL PNEUMONIA (Atypical pneumonia), PNEUMONITIS (Patient admitted with atypical pneumonia/pneumonitis), BRONCHOSPASM (Bronchospasm), OXYGEN SATURATION DECREASED (Initial SaO2 values to be in the low to mid 80% range), COUGH (Cough), HYPOXIA (Hypoxia) and DYSPNOEA (Increasing shortness of breath) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 immunisation.     The patient's past medical history included Obesity, Type II obese diabetic since an unknown date, Arterial hypertension, Dyslipidemia since an unknown date, Anxiety disorder since an unknown date and Endometrial cancer. Concomitant products included CLONAZEPAM, ZOLPIDEM, ESCITALOPRAM and AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ATYPICAL PNEUMONIA (Atypical pneumonia) (seriousness criterion hospitalization), PNEUMONITIS (Patient admitted with atypical pneumonia/pneumonitis) (seriousness criterion hospitalization), BRONCHOSPASM (Bronchospasm) (seriousness criterion hospitalization), OXYGEN SATURATION DECREASED (Initial SaO2 values to be in the low to mid 80% range) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization), HYPOXIA (Hypoxia) (seriousness criterion hospitalization) and DYSPNOEA (Increasing shortness of breath) (seriousness criterion hospitalization). The patient was hospitalized on 15-Mar-2021 due to ATYPICAL PNEUMONIA, BRONCHOSPASM, COUGH, DYSPNOEA, HYPOXIA, OXYGEN SATURATION DECREASED and PNEUMONITIS. At the time of the report, ATYPICAL PNEUMONIA (Atypical pneumonia), PNEUMONITIS (Patient admitted with atypical pneumonia/pneumonitis), BRONCHOSPASM (Bronchospasm), OXYGEN SATURATION DECREASED (Initial SaO2 values to be in the low to mid 80% range), COUGH (Cough), HYPOXIA (Hypoxia) and DYSPNOEA (Increasing shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Alanine aminotransferase: normal (normal) 53. On 15-Mar-2021, Albumin globulin ratio: normal (normal) 1.1. On 15-Mar-2021, Angiogram: normal (normal) No pulmonary embolus or signs of right heart strain. No thoracic aortic aneurysm or dissection. No enlarged supraclavicular or axillary lymph nodes.. On 15-Mar-2021, Aspartate aminotransferase: normal (normal) 18. On 15-Mar-2021, Blood albumin: normal (normal) 3.9 mg/dl. On 15-Mar-2021, Blood alkaline phosphatase: normal (normal) 74. On 15-Mar-2021, Blood bilirubin: normal (normal) 0.8 mg/dl. On 15-Mar-2021, Blood calcium: normal (normal) 9.1 mg/dl. On 15-Mar-2021, Blood chloride: normal (normal) 105 mEq/L. On 15-Mar-2021, Blood creatinine: 0.7 (normal) normal. On 15-Mar-2021, Blood glucose: 146 (High) high. On 15-Mar-2021, Blood potassium: normal (normal) 3.5 mEq/L. On 15-Mar-2021, Blood sodium: normal (normal) 138 mEq/L. On 15-Mar-2021, Blood urea: 11 mg/dl (normal) normal. On 15-Mar-2021, Brain natriuretic peptide: 17 pg/ml (normal) normal. On 15-Mar-2021, Carbon dioxide: normal (normal) 26 mEq/L. On 15-Mar-2021, Chest X-ray: normal (normal) Scattered areas of subpleural ground-glass opacification. On 15-Mar-2021, Computerised tomogram thorax: normal (normal) FINDINGS: Tracheal air shadow is normal. The aortic arch is not enlarged. Heart size is normal. No definite consolidation or effusion. IMPRESSION: No acute cardiopulmonary process. On 15-Mar-2021, Fibrin D dimer: normal (normal) Quantitative less than 200ng/mL. On 15-Mar-2021, Globulin: normal (normal) 3.7 gm/dL. On 15-Mar-2021, Haematocrit: 44 percent (normal) normal. On 15-Mar-2021, Haemoglobin: 14.1 (normal) 14.1. On 15-Mar-2021, Platelet count: normal (normal) 336 10^3/uL. On 15-Mar-2021, Protein total: normal (normal) 7.6 gm/dL. On 15-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 15-Mar-2021, Troponin I: normal (normal) 6.6. On 15-Mar-2021, White blood cell count: high (High) 15.42 10^3/uL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information mentioned.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Although a temporal association exists, based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Atypical pneumonia and pneumonitis are assessed as unlikely related. The other events are in consistence with the symptoms of Atypical pneumonia.  The patient's comorbidities of diabetes, hypertension, Endometrial cancer and obesity increases the risk of any infection including pneumonia.; Sender's Comments: Although a temporal association exists, based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Atypical pneumonia and pneumonitis are assessed as unlikely related. The other events are in consistence with the symptoms of Atypical pneumonia.  The patient's comorbidities of diabetes, hypertension, Endometrial cancer and obesity increases the risk of any infection including pneumonia.