Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pulmonary embolism, Venous thrombosis limb
Clinical narrative: Pulmonary Embolism; Blood clot, was on reporter's wife leg; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary Embolism) and VENOUS THROMBOSIS LIMB (Blood clot, was on reporter's wife leg) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0251921A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes (Patient checked with primary care due a suspected diabetes,).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary Embolism) (seriousness criteria death, hospitalization and medically significant) and VENOUS THROMBOSIS LIMB (Blood clot, was on reporter's wife leg) (seriousness criteria death, hospitalization and medically significant). an unknown date, the patient experienced DIARRHOEA (diarrhea). The patient was hospitalized until 21-Oct-2021 due to PULMONARY EMBOLISM and VENOUS THROMBOSIS LIMB. The patient died on 21-Oct-2021. The reported cause of death was Pulmonary embolism. It is unknown if an autopsy was performed. At the time of death, DIARRHOEA (diarrhea) had resolved.            Reporter states patient has no issues, before this blood clot. Concomitant medication information was not provided by the reporter.  Reporter mention that wife have some mild symptoms and diarrhea for a day, but other than that was fine. Patient checked with primary care due a suspected diabetes, Dr. told it was ok but reporter's wife leg was "falling out, and all swollen" so they went to ER and then hospitalized until passed away on 21Oct2021. It was reported that the patient died from a blood clot, was on reporter's wife leg and traveled all the way up to her heart. Cause of death Pulmonary Embolism.                    Treatment information was not provided by the reporter.  Company comment: This spontaneous case concerns a 69-year-old female patient with no relevant medical history reported, who experienced the unexpected fatal events of Leg Venous thrombosis and Pulmonary embolism after mRNA- 1273 Moderna vaccine. The onset of the events occurred on an unknown date after the second dose of mRNA- 1273 vaccine, patient was hospitalized and and had a fatal outcome 6 months and 27 days after the second dose. Clinical manifestations included peripheral swelling. Patient was hospitalized on an unknown date, very limited information is available regarding treatment and clinical course. Cause of death was reported as Pulmonary embolism. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old female patient with no relevant medical history reported, who experienced the unexpected fatal events of Leg Venous and Pulmonary embolism after mRNA- 1273 Moderna vaccine. The onset of the events occurred on an unknown date after the second dose of mRNA- 1273 vaccine and had a fatal outcome 6 months and 27 days after the second dose. Clinical manifestations included peripheral swelling. Patient was hospitalized on an unknown date, but very limited information is available regarding treatment and clinical course. Cause of death was reported as Pulmonary embolism. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report; Reported Cause(s) of Death: Pulmonary Embolism