Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Oxygen saturation, Pulmonary embolism, Ultrasound Doppler
Clinical narrative: Pulmonary embolism (PE)  in the pulmonary artery; DVT in the left leg; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (DVT in the left leg) and PULMONARY EMBOLISM (Pulmonary embolism (PE)  in the pulmonary artery) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Thrombectomy, Angiography (Pulmonary embolism was discovered) in June 2021 and Angioplasty (Stents were placed in upper left leg.) in June 2021. Concurrent medical conditions included Blood pressure high (Controlled with medication), High cholesterol (Controlled with medication) and GERD (Controlled with medication). Concomitant products included AMLODIPINE BESILATE (NORVASC) for Blood pressure, PRAVASTATIN for Cholesterol, OMEPRAZOLE for GERD.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT in the left leg) (seriousness criteria hospitalization, medically significant, life threatening and intervention required). On 17-Jun-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism (PE)  in the pulmonary artery) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized on 16-Jun-2021 due to DEEP VEIN THROMBOSIS, and then on 20-Jun-2021 due to PULMONARY EMBOLISM. The patient was treated with HEPARIN at a dose of 1 dosage form and APIXABAN (ELIQUIS) at a dose of 1 dosage form. At the time of the report, DEEP VEIN THROMBOSIS (DVT in the left leg) and PULMONARY EMBOLISM (Pulmonary embolism (PE)  in the pulmonary artery) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Oxygen saturation: 75 oxygen saturation: 75. On 15-Jun-2021, Ultrasound Doppler: Slow flow but no DVT.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DEEP VEIN THROMBOSIS (DVT in the left leg) and PULMONARY EMBOLISM (Pulmonary embolism (PE)  in the pulmonary artery) to be possibly related.    .No treatment information was provided. No relevant concomitant medications were reported.  Additional information added was that the patient was taken to the operating room and a surgeon removed clots from his left leg behind the knee and placed stents.   Company comment: This case refers to a 71-year-old male patient who experienced the serious unexpected events Deep vein thrombosis and Pulmonary embolism 4 months 29 days after receiving mRNA-1273 vaccine. The event Deep vein thrombosis was more consistent with the age related risk factors. Pulmonary embolism was more consistent with the possible complication of Deep vein thrombosis. 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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Added Patient's demographics, Concurrent conditions, Procedures, Concomitant Medications, Events and Updated dates of events and outcome of events. On 02-Sep-2021: Upon internal review on 27-Sep-2022, non-significant correction was performed: Case received from field was updated to blank; 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.