Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot in his right knee; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot in his right knee) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Apr-2022, the patient experienced THROMBOSIS (blood clot in his right knee) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN on 10-Apr-2022 for Adverse event, at a dose of 15 milligram twice a day. At the time of the report, THROMBOSIS (blood clot in his right knee) was resolving.            The patient took  moderna vaccine on 05-Apr-2022, three days later on 09-Apr-2022, he ended up in emergency. The patient had no allergies, never had COVID positive test or diagnosis and no other vaccines were taken within 1 month prior to Moderna COVID-19 vaccine. No concomitants were reported.  Starting on 10-Apr-2022, the patient had been taking blood thinner. He took rivaroxaban 15 mg starting from 10-Apr-2022 and he would take 20 mg for another 30 days, then he would go for reevaluation. The AE outcome was better and the symptoms improved.. Company comment: This is a spontaneous case concerning a 79 year-old, male patient with no relevant medical, who experienced the serious (due to medically important condition) unexpected, AESI of thrombosis, approximately 4 days after the second booster dose of mRNA-1273 vaccine. The patient reported that 3 days after vaccination he noticed pain in his right toe and right foot and swelling in his foot, which prompted him to seek medical attention in the emergency room the day after, with a thrombosis reported as blood clot in his right knee. He described that his right leg was an inch larger than his left leg, and more red in the calf area. He started treatment with rivaroxaban. The outcome was reported as recovering. Patient´s advanced age remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-542629 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 79 year-old, male patient with no relevant medical, who experienced the serious (due to medically important condition) unexpected, AESI of thrombosis, approximately 4 days after the second booster dose of mRNA-1273 vaccine. The patient reported that 3 days after vaccination he noticed pain in his right toe and right foot and swelling in his foot, which prompted him to seek medical attention in the emergency room the day after, with a thrombosis reported as blood clot in his right knee. He described that his right leg was an inch larger than his left leg, and more red in the calf area. He started treatment with rivaroxaban. The outcome was reported as recovering. Patient´s advanced age remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.