Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pulmonary embolism, Pyrexia, Somnolence, Thrombosis
Clinical narrative: Acute Pulmonary Embolism; bronchitis; Blood clot; Passed out 5 times that night; Couldn't breathe; Heart pain; Cough; Fever; Muscle sore; Super sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Acute Pulmonary Embolism), LOSS OF CONSCIOUSNESS (Passed out 5 times that night) and THROMBOSIS (Blood clot) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Emergency care (got X-ray and was told she possibly had bronchitis.) on 06-Jun-2021 and Emergency care (was hospitalized for 2 days with a diagnosis of Acute Pulmonary Embolism.) on 08-Jul-2021. Concurrent medical conditions included Drug allergy (Allergy to Hydrocodone) and Drug allergy (Allergy to Codeine). Concomitant products included VIT D [VITAMIN D NOS] for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced SOMNOLENCE (Super sleepy), PYREXIA (Fever) and MYALGIA (Muscle sore). On 15-May-2021, the patient experienced COUGH (Cough). On 06-Jun-2021, the patient experienced DYSPNOEA (Couldn't breathe) and CHEST PAIN (Heart pain). On 06-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out 5 times that night) (seriousness criterion medically significant). On 08-Jul-2021, the patient experienced PULMONARY EMBOLISM (Acute Pulmonary Embolism) (seriousness criteria hospitalization and medically significant). 08-Jul-2021, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant). On an unknown date, the patient experienced BRONCHITIS (bronchitis). The patient was treated with RIVAROXABAN (XARELTO VASCULAR) at a dose of 15mg. On 16-May-2021, SOMNOLENCE (Super sleepy), PYREXIA (Fever) and MYALGIA (Muscle sore) had resolved. On 10-Jul-2021, PULMONARY EMBOLISM (Acute Pulmonary Embolism) and THROMBOSIS (Blood clot) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out 5 times that night), DYSPNOEA (Couldn't breathe), CHEST PAIN (Heart pain), BRONCHITIS (bronchitis) and COUGH (Cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2021, X-ray: inconclusive (Inconclusive) possibly had bronchitis as reported by patient.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.