Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Malaise, Myalgia, Non-cardiac chest pain, Pulmonary embolism
Clinical narrative: inferred pulmonary embolism; deep vein thrombosis in right femoral vein; It was the second trimester in her pregnancy /Pregnant; Chest pain (non-cardiac); Shortness of breath; Feeling unwell; Insomnia; Feeling anxious; sore upper arm after first vaccine; Fever; Vaccination site pain; Fatigue; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (inferred pulmonary embolism) and DEEP VEIN THROMBOSIS (deep vein thrombosis in right femoral vein) 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) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PULMONARY EMBOLISM (inferred pulmonary embolism) (seriousness criterion medically significant), DEEP VEIN THROMBOSIS (deep vein thrombosis in right femoral vein) (seriousness criterion medically significant), EXPOSURE DURING PREGNANCY (It was the second trimester in her pregnancy /Pregnant), NON-CARDIAC CHEST PAIN (Chest pain (non-cardiac)), DYSPNOEA (Shortness of breath), MALAISE (Feeling unwell), INSOMNIA (Insomnia), ANXIETY (Feeling anxious), MYALGIA (sore upper arm after first vaccine), PYREXIA (Fever), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue). The delivery occurred on an unknown date. For neonate 1, patient was 25 weeks pregnant during the vaccination. The patient was treated with HEPARIN for DVT, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (inferred pulmonary embolism), DEEP VEIN THROMBOSIS (deep vein thrombosis in right femoral vein), NON-CARDIAC CHEST PAIN (Chest pain (non-cardiac)), DYSPNOEA (Shortness of breath), MALAISE (Feeling unwell), INSOMNIA (Insomnia), ANXIETY (Feeling anxious), MYALGIA (sore upper arm after first vaccine), PYREXIA (Fever), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue) outcome was unknown and EXPOSURE DURING PREGNANCY (It was the second trimester in her pregnancy /Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: abnormal (abnormal) DVT in right femoral vein.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported.   Concomitant was not reported.  In the emergency room, patient was diagnosed by sonogram for DVT in her right femoral vein. A chest x-ray was taken and due to the patient's symptoms a pulmonary embolism was inferred to be the cause without further need of investigation by CT scan due to the increased risk for pregnant females. patient was treated with a shot of low molecular weight heparin (LMWH) and continues to get a LMWH subdermal shot every twelve hours for the duration of her pregnancy.  After one night in the ICU, the patient was discharged with no further complications for pregnant patient or the fetus to date.  The blue-sky scenario is this patient developed a blood clot prior to vaccination, and the body's response to the vaccine caused enough stress to cause the emergent crisis.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-251142 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up information received contains No New Information.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.