Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Necrosis, Pulmonary embolism
Clinical narrative: Had loss of ability and was diagnosed of Multiple pulmonary Bilateral embolism; Dead Tissue after the Administering of the Moderna vaccines.; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Had loss of ability and was diagnosed of Multiple pulmonary Bilateral embolism) and NECROSIS (Dead Tissue after the Administering of the Moderna vaccines.) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third 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 (Had loss of ability and was diagnosed of Multiple pulmonary Bilateral embolism) (seriousness criterion medically significant) and NECROSIS (Dead Tissue after the Administering of the Moderna vaccines.) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) for Anticoagulant therapy, at a dose of 20 milligram once a day. At the time of the report, PULMONARY EMBOLISM (Had loss of ability and was diagnosed of Multiple pulmonary Bilateral embolism) and NECROSIS (Dead Tissue after the Administering of the Moderna vaccines.) outcome was unknown.            Concomitant product use was not provided by the reporter, no other medicines and no Vitamins. No allergies prior to the vaccines.  Patient was scheduled for confirmatory test to check if there is any other underlying cause to this loss of ability and blood clots, The Factor V Leiden Test to check (Suspected cause).  Company comment: This spontaneous case concerns a 58-year-old male patient, with relevant family history (son experienced blood clots after mRNA-1273 vaccine), who experienced the serious (medically significant) unexpected event of Pulmonary embolism (AESI) and necrosis (reported as dead tissue) after a dose of mRNA-1273,  without exact start date provided. It was reported that The Factor V Leiden Test result is pending. The patient was treated with anticoagulant therapy.  No further clinical information was available for medical reviewing.  Patient´s family history could be considered a contributing factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-478697 (Patient Link).; Sender's Comments: This spontaneous case concerns a 58-year-old male patient, with relevant family history (son experienced blood clots after mRNA-1273 vaccine), who experienced the serious (medically significant) unexpected event of Pulmonary embolism (AESI) and necrosis (reported as dead tissue) after a dose of mRNA-1273,  without exact start date provided. It was reported that The Factor V Leiden Test result is pending. The patient was treated with anticoagulant therapy.  No further clinical information was available for medical reviewing.  Patient´s family history could be considered a contributing factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.