Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Limb injury, Pain in extremity, Pulmonary embolism, Thrombosis
Clinical narrative: Blood clots; had Loss of ability and was diagnosed of Multiple pulmonary Bilateral embolism; Soreness in arms; not able to use my right arm for two days; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) and PULMONARY EMBOLISM (had Loss of ability and was diagnosed of Multiple pulmonary Bilateral embolism) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety attack. Concomitant products included ESCITALOPRAM for Anxiety attack.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced LIMB INJURY (not able to use my right arm for two days). On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant), PULMONARY EMBOLISM (had Loss of ability and was diagnosed of Multiple pulmonary Bilateral embolism) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Soreness in arms). The patient was treated with APIXABAN (ELIQUIS) at a dose of 5 milligram every twelve hours. In November 2021, LIMB INJURY (not able to use my right arm for two days) had resolved. At the time of the report, THROMBOSIS (Blood clots), PULMONARY EMBOLISM (had Loss of ability and was diagnosed of Multiple pulmonary Bilateral embolism) and PAIN IN EXTREMITY (Soreness in arms) outcome was unknown.            Patient had booster dose and got hospitalized at Emergency Room with Eliquis 5mg Twice a day,one morning and one evening.  Patient had Booster shot of Moderna .  The Factor V Leiden Test was reported to check as it was reported as Suspected underlying cause.  Company comment: This spontaneous case concerns a 22-year-old male patient, with relevant family history (father´s patient experienced blood clots after mRNA-1273 vaccine), who experienced the serious (medically significant) unexpected AESI of Pulmonary embolism and thrombosis after the third dose of mRNA-1273 (reported as booster dose)  without exact events start date provided. It was reported that The Factor V Leiden Test result is pending. The patient was treated with anticoagulant therapy at emergency room.  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-2022-478659 (Patient Link).; Sender's Comments: This spontaneous case concerns a 22-year-old male patient, with relevant family history (father´s patient experienced blood clots after mRNA-1273 vaccine), who experienced the serious (medically significant) unexpected AESI of Pulmonary embolism and thrombosis after the third dose of mRNA-1273 (reported as booster dose)  without exact events start date provided. It was reported that The Factor V Leiden Test result is pending. The patient was treated with anticoagulant therapy at emergency room.  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.