Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fibrin D dimer, Glomerular filtration rate, Mean cell haemoglobin concentration, N-terminal prohormone brain natriuretic peptide
Clinical narrative: Shortness of breath; Pulmonary emboli; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Pulmonary emboli) and DYSPNOEA (Shortness of breath) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 046B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mitral valve replacement (Mitral valve surgery with ring placement.) in 2021, Hysterectomy NOS and Mitral regurgitation on 13-Jun-2021. Previously administered products included for Product used for unknown indication: TDAP on 11-Feb-2017, TD on 04-Jun-2021, Shingrix and Influenza. Family history included Hypothyroidism since 30-Jan-2021. Concurrent medical conditions included Drug allergy (NSAIDS allergy was reported.), Drug allergy (ASA buff mag salicylates allergy was reported.), Obstructive sleep apnea syndrome (history of sleep apnea not on CPAP.) since 08-May-2014, Pulmonary hypertension, Right ventricular dysfunction (Right ventricular systolic dysfunction.) since 14-May-2014, Tachycardia since 20-Aug-2012 and German measles since 09-Apr-2006. Concomitant products included EPINEPHRINE (EPIPEN 2-PAK) from 13-Oct-2019 to an unknown date for Allergy NOS, PARACETAMOL (TYLENOL), VITAMIN D NOS, MULTIVITAMIN [VITAMINS NOS] and LEVOTHYROXINE for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY EMBOLISM (Pulmonary emboli) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization) and FATIGUE (Fatigue). The patient was hospitalized from 26-Apr-2021 to 28-Apr-2021 due to PULMONARY EMBOLISM. The patient was treated with APIXABAN (ELIQUIS) (oral) on 14-May-2021 at a dose of 5 milligram twice a day and ALBUTEROL SULFATE ongoing from 09-Jun-2021 at a dose of 1 dosage form every six hours. At the time of the report, PULMONARY EMBOLISM (Pulmonary emboli), DYSPNOEA (Shortness of breath) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Blood glucose: 112 (High) The patient blood glucose level was high. On 26-Apr-2021, Blood pressure diastolic: 168 (High) The blood pressure was high.. On 26-Apr-2021, Blood sodium: 139 (Inconclusive) The patient blood sodium level was 139mmol/L. On 26-Apr-2021, Chest X-ray: inconclusive (Inconclusive) The results were normal.. On 26-Apr-2021, Computerised tomogram: inconclusive (Inconclusive) Sub massive pulmonary embolism. On 26-Apr-2021, Echocardiogram: inconclusive (Inconclusive) Severe dilated right ventricle.. On 26-Apr-2021, Fibrin D dimer: 3.34 (High) The result was high.. On 26-Apr-2021, Mean cell haemoglobin concentration: 31.9 (Low) MCHC value was low.. On 26-Apr-2021, N-terminal prohormone brain natriuretic peptide: 571 (High) The result was high.. On 26-Apr-2021, Oxygen saturation: 99 (Inconclusive) The saturation was 99%.. On 26-Apr-2021, SARS-CoV-2 test: negative (Negative) Result was negative.. On 27-Apr-2021, Activated partial thromboplastin time: 58.01 (High) The result was high.. On 27-Apr-2021, Angiogram: inconclusive (Inconclusive) No acute pulmonary embolism.. On 27-Apr-2021, Blood sodium: 138 (Inconclusive) The patient blood sodium level was 138mmol/L. On 27-Apr-2021, Mean cell haemoglobin concentration: 32.2 (Low) The result was abnormal.. On 27-Apr-2021, Oxygen saturation: 94 (Inconclusive) The saturation was 95%.. On 28-Apr-2021, Anion gap: 8 (Inconclusive) Anion gap was 8.. On 28-Apr-2021, Blood bicarbonate: 27 (Inconclusive) The patient blood sodium level was 27mmol/L. On 28-Apr-2021, Blood chloride: 101 (Inconclusive) The patient blood chloride level was 101 mmol/L.. On 28-Apr-2021, Blood creatinine: 0.7 (Inconclusive) The patient blood creatinine level was 0.7mg/dl.. On 28-Apr-2021, Blood potassium: 5 (Inconclusive) The patient blood potassium level was 5 mmol/L.. On 28-Apr-2021, Blood sodium: 136 (Inconclusive) The patient blood sodium level was 136 mmol/L. On 28-Apr-2021, Blood urea: 11 (Inconclusive) Blood urea level was 11mg/dl.. On 28-Apr-2021, Glomerular filtration rate: 95 (Inconclusive) Non African American GFR result was 95.. On 28-Apr-2021, Oxygen saturation: 95 (Inconclusive) The saturation was 94%.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information were not provided.  Action taken with mRNA-1273 in response to the events were not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.