Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Computerised tomogram, Heart rate, Hypertension, Pulmonary embolism
Clinical narrative: left embolism in left lung; High BP / m Blood Pressure of 145/115; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (left embolism in left lung) and HYPERTENSION (High BP / m Blood Pressure of 145/115) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 017B21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Patient had a prior medical history of double by pass surgery) and AFib (patient was a not an a-fib patient anymore but takes medications as prophylactic.). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), LOSARTAN, PRAVASTATIN, OMEPRAZOLE, AMLODIPINE BESYLATE and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (left embolism in left lung) (seriousness criteria hospitalization, medically significant and life threatening) and HYPERTENSION (High BP / m Blood Pressure of 145/115) (seriousness criterion hospitalization). The patient was hospitalized from 14-Oct-2021 to sometime in October 2021 due to HYPERTENSION and PULMONARY EMBOLISM. The patient was treated with ISOSORBIDE MONONITRATE for Adverse event, at an unspecified dose and frequency; BUDESONIDE for Adverse event, at an unspecified dose and frequency; IPRATROPIUM for Adverse event, at an unspecified dose and frequency; SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for Adverse event, at an unspecified dose and frequency; PANTOPRAZOLE SODIUM for Adverse event, at an unspecified dose and frequency; LOSARTAN POTASSIUM for Adverse event, at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency; SALBUTAMOL SULFATE (VENTOLIN HFA) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ENOXAPARIN SODIUM for Adverse event, at an unspecified dose and frequency. On 14-Oct-2021, PULMONARY EMBOLISM (left embolism in left lung) and HYPERTENSION (High BP / m Blood Pressure of 145/115) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 145/115 (High) Blood pressure 145/115 high. On an unknown date, Computerised tomogram: abnormal (abnormal) diagnosed with left embolism in left lung. On an unknown date, Heart rate: 130-140 (High) Heart rate 130-140 high, Heart Rate of 150+.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that he experienced high blood pressure and high heart rate. he was hospitalized On 14 Oct-2021 for 2 days and then discharged on 3rd day.  Company Comment: This case concerns a 79-year-old male patient with a history of atrial fibrillation and double bypass surgery, who experienced the unexpected, serious (hospitalization, life threatening and medically significant) events of Pulmonary embolism and hypertension. The events occurred approximately 6 after the first dose of mRNA-1273 and 5 after the second dose of mRNA-1273. The rechallenge was not applicable. The medical history of atrial fibrillation and double bypass surgery are confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 79-year-old male patient with a history of atrial fibrillation and double bypass surgery, who experienced the unexpected, serious (hospitalization, life threatening and medically significant) events of Pulmonary embolism and hypertension. The events occurred approximately 6 after the first dose of mRNA-1273 and 5 after the second dose of mRNA-1273. The rechallenge was not applicable. The medical history of atrial fibrillation and double bypass surgery are confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.