Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Exposure during pregnancy, Fatigue, Hypokinesia, Inappropriate schedule of product administration
Clinical narrative: she was diagnosed by sonogram for DVT in her right femoral vein; Pulmonary embolism; Chest pain; Could not move around normally, sharp pain in her right left when she put weight on it; Couldnot breath normally ,having difficulty breathing and had to pause in the middle of sentences to catch her breath; Discovered a sharp pain in her right leg,when she put weight on it that felt like a string being pulled tight; Uncomfortable; Inappropriate schedule of vaccine administered; The patient was discharged with no further complications for her or the; after second vaccine, began feeling progressively tired and uncomfortable; Feverish; Anxious; could not sleep; Began feeling very unwell; body's response to the vaccine caused enough stress to cause the emergent crisis; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (she was diagnosed by sonogram for DVT in her right femoral vein) and PULMONARY EMBOLISM (Pulmonary embolism) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), EXPOSURE DURING PREGNANCY (The patient was discharged with no further complications for her or the), DISCOMFORT (Uncomfortable) and FATIGUE (after second vaccine, began feeling progressively tired and uncomfortable). On 03-May-2021, the patient experienced DEEP VEIN THROMBOSIS (she was diagnosed by sonogram for DVT in her right femoral vein) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Chest pain), HYPOKINESIA (Could not move around normally, sharp pain in her right left when she put weight on it), DYSPNOEA (Couldnot breath normally ,having difficulty breathing and had to pause in the middle of sentences to catch her breath) and PAIN IN EXTREMITY (Discovered a sharp pain in her right leg,when she put weight on it that felt like a string being pulled tight). 03-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). In May 2021, the patient experienced ANXIETY (Anxious). May 2021, the patient experienced INSOMNIA (could not sleep), MALAISE (Began feeling very unwell), STRESS (body's response to the vaccine caused enough stress to cause the emergent crisis) and PYREXIA (Feverish). The patient was treated with LOW MOLECULAR WEIGHT HEPARIN (subdermal) ongoing from 03-May-2021 for DVT, at a dose of 1 dosage form every twelve hours. On 02-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (The patient was discharged with no further complications for her or the), DEEP VEIN THROMBOSIS (she was diagnosed by sonogram for DVT in her right femoral vein), PULMONARY EMBOLISM (Pulmonary embolism), CHEST PAIN (Chest pain), DISCOMFORT (Uncomfortable), ANXIETY (Anxious), INSOMNIA (could not sleep), MALAISE (Began feeling very unwell), HYPOKINESIA (Could not move around normally, sharp pain in her right left when she put weight on it), DYSPNOEA (Couldnot breath normally ,having difficulty breathing and had to pause in the middle of sentences to catch her breath), PAIN IN EXTREMITY (Discovered a sharp pain in her right leg,when she put weight on it that felt like a string being pulled tight), STRESS (body's response to the vaccine caused enough stress to cause the emergent crisis), FATIGUE (after second vaccine, began feeling progressively tired and uncomfortable) and PYREXIA (Feverish) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Chest X-ray: abnormal (abnormal) Pulmonary embolism. On 03-May-2021, Ultrasound scan: abnormal (abnormal) DVT in right femoral vein.         No concomitant medications were reported. After one night in the ICU, the patient was discharged with no further complications for her or the fetus to date.  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.   This case was linked to MOD-2021-251077 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: No new information added; 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.