Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Coagulation test, Condition aggravated, Electrocardiogram, Oxygen saturation
Clinical narrative: Pulmonary embolism; vaccine-related thrombosis; Condition aggravated; This literature-non-study case was reported in a literature article and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism), THROMBOSIS (vaccine-related thrombosis) and CONDITION AGGRAVATED (Condition aggravated) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:     The patient's past medical history included Retroperitoneal hematoma (due to an aneurysm), Aneurysm (aneurysm posterior to the pancreatic head) and Aneurysm embolization. Previously administered products included for Pulmonary embolism: rivaroxaban (monitored closely for possible bleeding). Past adverse reactions to the above products included No adverse event with rivaroxaban. Concurrent medical conditions included Hypertension, Paroxysmal atrial fibrillation, Pulmonary embolism (bilateral pulmonary embolism) and Iliac vein thrombosis (thought to be a direct result of compression from the hematoma).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant), THROMBOSIS (vaccine-related thrombosis) (seriousness criteria hospitalization and medically significant) and CONDITION AGGRAVATED (Condition aggravated) (seriousness criteria hospitalization and medically significant). The patient was treated with APIXABAN ongoing since an unknown date for Pulmonary embolism, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism), THROMBOSIS (vaccine-related thrombosis) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: pulmonary embolism (abnormal) CT angiogram of the chest showed pulmonary embolism in the right middle lobe segmental branch without right ventricular strain. On an unknown date, Coagulation test: normal (normal) Normal. On an unknown date, Electrocardiogram: normal (normal) No EKG changes. On an unknown date, Oxygen saturation: normal (normal) hemodynamically stable with normal oxygen saturation in room air. On an unknown date, Platelet count: normal (normal) Normal. On an unknown date, Troponin: not elevated (normal) Not elevated.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PULMONARY EMBOLISM (Pulmonary embolism), THROMBOSIS (vaccine-related thrombosis) and CONDITION AGGRAVATED (Condition aggravated) to be related.    Concomitant medications were not reported.  The patient had no family history of clotting disorder, recent surgery, and had no known malignancy.  Patient stopped rivaroxaban after one month due to financial reasons.  The patient was presented to the hospital with chest tightness for 3 days and 2 days later patient started having left-sided chest tightness and dizziness.  Company comment This literature case concerns a 62 year old female patient with medical history of hypertension, paroxysmal atrial fibrillation, retroperitoneal hematoma, aneurysm with embolization, bilateral pulmonary embolism and Iliac vein thrombosis who experienced the unexpected serious (hospitalization, important medical event) events of Pulmonary embolism (AESI), Thrombosis (AESI) and Condition aggravated unspecified days after receiving the second dose of mRNA-1273 vaccine. CT angiogram of the chest showed pulmonary embolism in the right middle lobe segmental branch without right ventricular strain. Patient was treated with apixaban. At the time of the report, the outcome of the events was unknown. Medical history of hypertension, paroxysmal atrial fibrillation, retroperitoneal hematoma, aneurysm with embolization, bilateral pulmonary embolism and Iliac vein thrombosis could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2022: Follow up received by safety on 02-Mar-2022 has Email with full text article received from team and contains significant information: Authors name and year updated in literature information; Sender's Comments: This literature case concerns a 62 year old female patient with medical history of hypertension, paroxysmal atrial fibrillation, retroperitoneal hematoma, aneurysm with embolization, bilateral pulmonary embolism and Iliac vein thrombosis who experienced the unexpected serious (hospitalization, important medical event) events of Pulmonary embolism (AESI), Thrombosis (AESI) and Condition aggravated unspecified days after receiving the second dose of mRNA-1273 vaccine. CT angiogram of the chest showed pulmonary embolism in the right middle lobe segmental branch without right ventricular strain. Patient was treated with apixaban. At the time of the report, the outcome of the events was unknown. Medical history of hypertension, paroxysmal atrial fibrillation, retroperitoneal hematoma, aneurysm with embolization, bilateral pulmonary embolism and Iliac vein thrombosis could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.