Received Dec 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
DVT in the right leg; pulmonary embolism; shortness of air; This spontaneous case was reported by an other health care professional and describes the occurrence of DEEP VEIN THROMBOSIS (DVT in the right leg) and PULMONARY EMBOLISM (pulmonary embolism) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Neuromuscular disorder NOS, Back surgery, Cholecystectomy, Hysterectomy (cervix status unknown), Pancreatic operation NOS, Spinal operation NOS, Partial splenectomy and Thyroid operation NOS. Concurrent medical conditions included Cancer, Chronic pain, Diabetes mellitus, Hypertension and Hyperthyroidism. In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DEEP VEIN THROMBOSIS (DVT in the right leg) (seriousness criterion medically significant), PULMONARY EMBOLISM (pulmonary embolism) (seriousness criterion medically significant) and DYSPNOEA (shortness of air). At the time of the report, DEEP VEIN THROMBOSIS (DVT in the right leg), PULMONARY EMBOLISM (pulmonary embolism) and DYSPNOEA (shortness of air) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications provided by the reporter. It was reported that the patient received Moderna Covid vaccine on 4/21 and few weeks later the patient noticed a DVT in the right leg and ended up with shortness of air and a pulmonary embolism. It was unknown if the patient experienced any additional symptoms/events. No treatment medications provided by the reporter.; Reporter's Comments: Company Comment: The benefit-risk relationship of the product is not affected by this report.
Cancer; Diabetes mellitus; Hypertension; Hyperthyroidism
Medical History/Concurrent Conditions: Back surgery; Cholecystectomy; Chronic pain; Hysterectomy (cervix status unknown); Neuromuscular disorder NOS; Pancreatic operation NOS; Partial splenectomy; Spinal operation NOS; Thyroid operation NOS