Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, SARS-CoV-2 test, Thrombosis, Ultrasound Doppler
Clinical narrative: Did a CT scan and saw blood clots in pulmonary arteries, small blood clot in legs; having problem with breathing; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Did a CT scan and saw blood clots in pulmonary arteries, small blood clot in legs) and DYSPNOEA (having problem with breathing) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21, 001A21A and 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-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 THROMBOSIS (Did a CT scan and saw blood clots in pulmonary arteries, small blood clot in legs) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (having problem with breathing) (seriousness criterion hospitalization). The patient was hospitalized from 12-Apr-2022 to 13-Apr-2022 due to DYSPNOEA and THROMBOSIS. The patient was treated with RIVAROXABAN (XARELTO) ongoing since an unknown date at a dose of for 21 days 15mg/twice a day, now1/day 20mg. At the time of the report, THROMBOSIS (Did a CT scan and saw blood clots in pulmonary arteries, small blood clot in legs) and DYSPNOEA (having problem with breathing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2022, Computerised tomogram: blood clot in pulmonary arteries Blood clot in Pulmonary arteries. In April 2022, Ultrasound Doppler: blood clot in legs (abnormal) Blood clot in legs. On an unknown date, SARS-CoV-2 test: negative (Negative) had two COVID tests that came back negative..         Patient is on medicine for high blood pressure and OTC medicine for heart burn. Patient was put on blood thinners at the emergency department. During hospitalization patient was treated with Xarelto for 21 days of 15mg/twice a day (1am and 1 pm with meal) and he is on 1/day 20mg.He was also put on a a low dose blood pressure medicine a few days before the CT scan but he was off on them at the time of reporting. Patient Cardiologist has also referred him to hematologist and would be referring to pulmonary in August. Patient stated that couple of doctors suggested that the events might be because of the shot, others said no.  Company Comment: This is a spontaneous case concerning  a  73-year-old, male patient with Concurrent medical conditions of Blood pressure high, who experienced the unexpected serious (medically significant and Hospitalization) events Thrombosis, Dyspnea. The events occurred on an unknown date after the third dose of mRNA-1273 COVID 19 Vaccine. Computerised tomogram showed blood clot in pulmonary arteries. Ultrasound doppler showed abnormal results blood clots in legs. Patient was treated with Rivaroxaban 15mg, 2x a day for 21 days, currently on 20mg once a day. The events outcome were unknown. The Concurrent medical conditions of Blood pressure high remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2022-562756.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  73-year-old, male patient with Concurrent medical conditions of Blood pressure high, who experienced the unexpected serious (medically significant and Hospitalization) events Thrombosis, Dyspnea. The events occurred on an unknown date after the third dose of mRNA-1273 COVID 19 Vaccine. Computerised tomogram showed blood clot in pulmonary arteries. Ultrasound doppler showed abnormal results blood clots in legs. Patient was treated with Rivaroxaban 15mg, 2x a day for 21 days, currently on 20mg once a day. The events outcome were unknown. The Concurrent medical conditions of Blood pressure high remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.