Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Haematology test, Haemoglobin, International normalised ratio, Platelet count
Clinical narrative: Bilateral segmental PE; DVT; Shortness of breath; This literature-study case was reported in a literature article and describes the occurrence of PULMONARY EMBOLISM (Bilateral segmental PE), DEEP VEIN THROMBOSIS (DVT) and DYSPNOEA (Shortness of breath) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gastrointestinal bleed and Breast cancer (Diagnosed and treated in 2009) in 2009. Concurrent medical conditions included Osteoporosis. Concomitant products included RALOXIFENE for Osteoporosis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Bilateral segmental PE) (seriousness criteria hospitalization and medically significant), DEEP VEIN THROMBOSIS (DVT) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to DEEP VEIN THROMBOSIS, DYSPNOEA and PULMONARY EMBOLISM. The patient was treated with ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) for Pulmonary embolism, at a dose of UNK, bid and RIVAROXABAN for Pulmonary embolism, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Bilateral segmental PE), DEEP VEIN THROMBOSIS (DVT) and DYSPNOEA (Shortness of breath) was resolving. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Angiogram pulmonary: abnormal (abnormal) notable for bilateral segmental PE. In 2021, Brain natriuretic peptide: 667 pg/ml (Inconclusive) 667 pg/ml. In 2021, Echocardiogram: abnormal (abnormal) mild right ventricular strain and 1 (Inconclusive) 1. In 2021, Fibrin D dimer: 10.61 ug/ml (Inconclusive) 10.61 ug/ml. In 2021, Haematology test: negative (Negative) A hypercoagulable panel performed was negative for a genetic predisposition to VTE (hospital days 2-4). In 2021, Haemoglobin: 16.9 gm/dl (Inconclusive) 16.9 gm/dl. In 2021, International normalised ratio: 1.2 (Inconclusive) 1.2. In 2021, Platelet count: 162 (Inconclusive) 162 per mm to the power 3. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Troponin (Unknown-<0.01): 0.46 ng/ml (High) 0.46 ng/ml. In 2021, Ultrasound Doppler: abnormal (abnormal) revealed DVT of the right common femoral and profunda veins.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PULMONARY EMBOLISM (Bilateral segmental PE), DEEP VEIN THROMBOSIS (DVT) and DYSPNOEA (Shortness of breath) to be possibly related.    Patient was presented to the emergency  department with four days of shortness of breath. She had received the first of the mRNA-1273  vaccine series three days prior to symptom onset.   She required 6 liters of supplemental oxygen upon arrival to the hospital. Overnight, On treatment, patient's symptoms improved and her oxygen requirement dropped to 3 liters. She was discharged from the hospital on day 5.  Patient was active and lived independently and denied any personal or family history of VTE or any thrombotic disorders, recent surgery, trauma, or any recent travel.  Laboratory test also included RV/LV ratio as 2.4.  Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-282332, MOD-2021-282441 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.