Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Fatigue, Incorrect route of product administration, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Large Blood clots on lungs/Pulmonary embolism; Blood clot in legs; Getting tired; Inappropriate route of administration; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Large Blood clots on lungs/Pulmonary embolism) and DEEP VEIN THROMBOSIS (Blood clot in legs) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hyperglycemia. Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for Blood pressure high, METFORMIN for Diabetes.  On 31-Aug-2021 at 4:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 31-Aug-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of administration). On 09-Sep-2021 at 5:00 AM, the patient experienced PULMONARY EMBOLISM (Large Blood clots on lungs/Pulmonary embolism) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (Blood clot in legs) (seriousness criteria hospitalization and medically significant) and FATIGUE (Getting tired). The patient was hospitalized from 12-Sep-2021 to 15-Sep-2021 due to DEEP VEIN THROMBOSIS and PULMONARY EMBOLISM. The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at a dose of UNK, qd and OXYGEN at an unspecified dose and frequency. On 31-Aug-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of administration) had resolved. At the time of the report, PULMONARY EMBOLISM (Large Blood clots on lungs/Pulmonary embolism) had not resolved and DEEP VEIN THROMBOSIS (Blood clot in legs) and FATIGUE (Getting tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant medications include 1 daily dose of unknown Blood pressure meds.  Patient had shortness of breath and it was escalated. Had to call paramedics and he was on oxygen on 12-Sep-2021 around 5 p.m. Patient rushed to the hospital, in emergency room many tests were performed. No COVID-19 or delta. Put him on a fast acting blood thinner via IV and sent him to ICU. Large blood clots found in his lungs and a new in his legs.Reported on oxygen in ICU for 3 days. Patient left from hospital, had to be on Eliquis for six months to a day. Patient went to requital(PC) doctor. Doctor suggested keep taking Eliquis (Blood thinner). And no aspirin.  Company Comment - This case concerns a  69 year-old male patient, with medical history of hypertension and hyperglycemia, who experienced serious unexpected AESI of Pulmonary embolism and deep vein thrombosis after first dose of mRNA-1273. Additionally, inappropriate route of product administration was also reported. The events occurred 10 days after the first dose of mRNA-1273 vaccine. The re-challenge is unknown as there is no information available about second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Reporter's information added, patient information added, vaccine information added, vaccination facility information added, Concomitant drug and treatment drug added, Events added.; Sender's Comments: This case concerns a  69 year-old male patient, with medical history of hypertension and hyperglycemia, who experienced serious unexpected AESI of Pulmonary embolism and deep vein thrombosis after first dose of mRNA-1273. Additionally, inappropriate route of product administration was also reported. The events occurred 10 days after the first dose of mRNA-1273 vaccine. The re-challenge is unknown as there is no information available about second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.