Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombosis
Clinical narrative: significant swelling in the lower left leg; blood clots in left leg/it was multiple blood clots in lower left leg started from into the knee all the way down into the lower left leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots in left leg/it was multiple blood clots in lower left leg started from into the knee all the way down into the lower left leg) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A, 021B21A and 064H12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN and LISINOPRIL for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced THROMBOSIS (blood clots in left leg/it was multiple blood clots in lower left leg started from into the knee all the way down into the lower left leg) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (significant swelling in the lower left leg). The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clots in left leg/it was multiple blood clots in lower left leg started from into the knee all the way down into the lower left leg) and PERIPHERAL SWELLING (significant swelling in the lower left leg) outcome was unknown.            The patient stated that 8 weeks from 07-May, the day of the second dose, the patient was diagnosed by primary care provider for having blood clots in left leg. The patient stated that there were multiple blood clots in lower left leg that started from into the knee all the way down into the lower left leg. The patient also stated that there was a significant swelling in the lower left leg and stated that had no history of blood clots prior to this.The patient was put on Eliquis and was still taking Eliquis and received the booster dose today per doctor's orders. Company comment: This case concerns a 62-year-old male patient, with no medical history reported, who experienced the serious unexpected event of thrombosis. The event occurred approximately two months after the second dose of mRNA-1273. The rechallenge is not applicable since no information about the third dose has been disclosed. The use of concomitant ROSUVASTATIN and LISINOPRIL suggestive of underlying hypertension and hypercholesterolemia, could be considered as confounders. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 62-year-old male patient, with no medical history reported, who experienced the serious unexpected event of thrombosis. The event occurred approximately two months after the second dose of mRNA-1273. The rechallenge is not applicable since no information about the third dose has been disclosed. The use of concomitant ROSUVASTATIN and LISINOPRIL suggestive of underlying hypertension and hypercholesterolemia, could be considered as confounders. The benefit-risk relationship of the mRNA-1273 is not affected by this report.