Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Malaise, Peripheral swelling, Thrombosis, Varicose vein
Clinical narrative: not feeling all that great; vein on their right leg above their knee was hard and purple; a massive swelling on their right leg; fell; Diagnosed with a blood clot in their right leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Diagnosed with a blood clot in their right leg) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes (20 years ago they had DBT(Diabetes). Patient state they do not take any medication regularly. ).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced THROMBOSIS (Diagnosed with a blood clot in their right leg) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (not feeling all that great), VARICOSE VEIN (vein on their right leg above their knee was hard and purple), PERIPHERAL SWELLING (a massive swelling on their right leg) and FALL (fell). At the time of the report, THROMBOSIS (Diagnosed with a blood clot in their right leg), MALAISE (not feeling all that great), VARICOSE VEIN (vein on their right leg above their knee was hard and purple), PERIPHERAL SWELLING (a massive swelling on their right leg) and FALL (fell) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  Patients went to a HCP, vein specialist, who prescribe they take daily shots of blood thinners for 6 weeks.   Company comment:This case concerns a 68-year-old, female patient with previous relevant medical history of diabetes, who experienced the unexpected event of thrombosis. The event occurred 27 days day after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-317836, US-MODERNATX, INC.-MOD-2021-317918, US-MODERNATX, INC.-MOD-2021-318381 (E2B Linked Report).; Sender's Comments: This case concerns a 68-year-old, female patient with previous relevant medical history of diabetes, who experienced the unexpected event of thrombosis. The event occurred 27 days day after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested. US-MODERNATX, INC.-MOD-2021-317836:Same reporter and Patient but different event US-MODERNATX, INC.-MOD-2021-317918:Same reporter and Patient but different event US-MODERNATX, INC.-MOD-2021-318381:Same reporter and Patient but different event