Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea exertional, Electrocardiogram abnormal, Myocardial strain, Pulmonary embolism, Scan with contrast abnormal
Clinical narrative: pulmonary embolism; shortness of breath, shortness of breath was getting worse; Nausea; migraine; Myalgia; low grade fever; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism) and DYSPNOEA (shortness of breath, shortness of breath was getting worse) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047821A and 014M2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Prostate cancer and Proctectomy. Concurrent medical conditions included Asthma, Hypertension (Controlled), Hypercholesterolemia (Controlled), Failed back surgery syndrome, Chronic back pain, Drug allergy (NSAIDs), Drug allergy (Fluconazole (Fluticasone)) and Drug allergy (Zipro). Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, DENOSUMAB (PROLIA), ALBUTEROL [SALBUTAMOL], ALPRAZOLAM (XANAX), CELECOXIB (CELEBREX), RIVAROXABAN (XARELTO), TADALAFIL (CIALIS), CEFIXIME (FLEXERIL [CEFIXIME]), MAGNESIUM, ZONISAMIDE (ZONEGRAN), OXYCODONE, EZETIMIBE (ZETIA), PRAVASTATIN, RAMIPRIL and CARVEDILOL for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced MIGRAINE (migraine), MYALGIA (Myalgia) and PYREXIA (low grade fever). On 28-Mar-2021, the patient experienced NAUSEA (Nausea). On 29-Mar-2021, the patient experienced DYSPNOEA (shortness of breath, shortness of breath was getting worse) (seriousness criterion hospitalization). On 02-Apr-2021, the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 02-Apr-2021 to 05-Apr-2021 due to DYSPNOEA and PULMONARY EMBOLISM. On 28-Mar-2021, PYREXIA (low grade fever) had resolved. At the time of the report, PULMONARY EMBOLISM (pulmonary embolism), DYSPNOEA (shortness of breath, shortness of breath was getting worse), MIGRAINE (migraine), MYALGIA (Myalgia) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Physical examination: normal (normal) no findings. On 27-Mar-2021, Body temperature: 37.8 degree Celsius (High) Self Test. In April 2021, Computerised tomogram: abnormal (abnormal) pulmonary embolism with CAT scan with dye, multiple pulmonary embolism in the lungs.. In April 2021, Fibrin D dimer: high (High) High. In April 2021, Ultrasound scan: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PULMONARY EMBOLISM (pulmonary embolism) and DYSPNOEA (shortness of breath, shortness of breath was getting worse) to be possibly related. No further causality assessments were provided for MIGRAINE (migraine), MYALGIA (Myalgia), PYREXIA (low grade fever) and NAUSEA (Nausea).    Treatment medications included sumatriptan (for migraine), and prednisone and home nebulize albuterol (for asthma exacerbation).  Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded     This case was linked to US-MODERNATX, INC.-MOD-2021-070707 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded US-MODERNATX, INC.-MOD-2021-070707:Same reporter/Different patient