Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin, High density lipoprotein, Low density lipoprotein, Magnetic resonance imaging, Prostatic specific antigen
Clinical narrative: Ventricular tachycardia; Pulmonary hypertension, unspecified (Chronic); Aneurysm of unspecified site; This spontaneous case was reported by a nurse and describes the occurrence of VENTRICULAR TACHYCARDIA (Ventricular tachycardia) and PULMONARY HYPERTENSION (Pulmonary hypertension, unspecified (Chronic)) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Postoperative delirium (Postoperative delirium after anesthesia lasted for minutes to hours.) from 14-Jun-2018 to June 2018, Non ST segment elevation myocardial infarction (ICD-10-CM was I21.4 and priority was low.) from 10-Jul-2018 to 10-Aug-2021, Community acquired pneumonia (ICD-10-CM was J18.9 and priority was low.) from 15-Nov-2016 to 14-Jun-2018, Hemoptysis (Had few episodes of Scant hemoptysis) in 2016, Dry cough in 2016 and Cardiac catheterization (Showed severe disease in LAD, first diagonal and septal branch.) on 07-Oct-2015. Previously administered products included for Community acquired pneumonia: Cherritussin (6 days) from 06-Nov-2016 to November 2016 and Levaquin (6 days) from 06-Nov-2016 to November 2016. Past adverse reactions to the above products included No adverse event with Cherritussin and Levaquin. Concurrent medical conditions included Colon adenomatous polyp (ICD-10-CM was Z86.010 and priority was low.) since 27-Aug-2020, Unstable angina (Unstable angina. ICD-10-CM was 120.0 and priority was low.) since 10-Jul-2018, Combative reaction (ICD-10-CM was Z78.9 and priority was low.) since 14-Jun-2018, Laceration of leg (ICD-10-CM was S81.812A and priority was low.) since 03-Oct-2017, Parotid tumor (ICD-10-CM was D49.0 and priority was low.) since 16-May-2017, Hyperlipidemia (Mixed, Chronic. ICD-10-CM was E78.2 and priority was low.) since 20-Nov-2016, Posterior vitreous detachment (Both eye. ICD-10-CM was H43.813 and priority was low.) since 06-Sep-2016, Nuclear sclerosis of the eye (Both eye. ICD-10-CM was H25.13 and priority was low.) since 06-Sep-2016, Knee pain (Bilateral chronic.) since 02-Jun-2016, Cyst (Cyst of neck. ICD-10-CM was IMO0002 and priority was low.) since 01-Mar-2016, Benign prostatic hyperplasia (Non-nodular.ICD-10-CM was N40.1 and priority was low.) since 01-Dec-2015, Lower urinary tract symptoms (Benign non-nodular prostatic hyperplasia with lower urinary tract symptoms.) since 01-Dec-2015, Type 2 diabetes mellitus (Controlled. ICD-10-CM was E11.59 and priority was low.), Type II diabetes mellitus with peripheral circulatory disorders (ICD-10-CM was E11.59 and priority was low.), Hematuria (ICD-10-CM was R31 and priority was low.) since 15-Oct-2015, Essential hypertension (Chronic. ICD-10-CM was I10 and priority was low.) since 15-Oct-2015, Coronary artery disease (CAD involving native coronary artery of native heart.) since 07-Oct-2015, Angina pectoris (CAD involving native coronary artery of native heart with angina pectoris.) since 07-Oct-2015, Diverticulitis of colon (without mention of haemorrhage) (ICD-10-CM was K57.32 and priority was low.) since 16-Sep-2015, Drug allergy (Baclofen), Allergy to antibiotic (Clindamycin), Allergy to antibiotic (Doxycycline), Grass allergy, Drug allergy (Meloxicam), Drug allergy (Propranolol), Sulfonamide allergy, Allergy to antibiotic (Vibramycin) and Pleomorphic adenoma since May 2017. Concomitant products included ATORVASTATIN, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), METFORMIN, LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID], CLOPIDOGREL BISULFATE (PLAVIX) and METOPROLOL for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Apr-2021, the patient experienced VENTRICULAR TACHYCARDIA (Ventricular tachycardia) (seriousness criterion medically significant), PULMONARY HYPERTENSION (Pulmonary hypertension, unspecified (Chronic)) (seriousness criterion medically significant) and ANEURYSM (Aneurysm of unspecified site). On 08-Oct-2021, VENTRICULAR TACHYCARDIA (Ventricular tachycardia) had resolved. On 11-Jan-2022, ANEURYSM (Aneurysm of unspecified site) had resolved. At the time of the report, PULMONARY HYPERTENSION (Pulmonary hypertension, unspecified (Chronic)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2015, Albumin urine: 7.4 (normal) 7.4 mcg/mg creatinine. On 25-May-2016, Prostatic specific antigen: 0.54 0.54 ng/ml. On 18-Nov-2016, Albumin urine: 6.3 (normal) 6.3 mcg/mg. On 18-Nov-2016, Haemoglobin: 6.1 (High) 6.1 %. On 01-Jan-2017, Haemoglobin: 6.2 (High) 6.2 %. On 01-May-2017, Prostatic specific antigen: 0.39 0.39 ng/ml. In 2017, Magnetic resonance imaging: abnormal (abnormal) Left medial meniscus tear. On 12-Jul-2017, Albumin urine: 6.1 (normal) 6.1 mcg/mg. On 12-Jul-2017, Haemoglobin: 6 (High) 6 %. On 07-Dec-2017, Blood cholesterol: 93 (normal) 93. On 07-Dec-2017, Blood triglycerides: 167 (High) 167. On 07-Dec-2017, High density lipoprotein: 32 (Low) 32. On 07-Dec-2017, Low density lipoprotein: 28 (normal) 28. On 11-Jun-2018, Haemoglobin: 6 (High) 6 %. On 10-Jul-2018, Blood cholesterol: 111 (normal) 111. On 10-Jul-2018, Blood triglycerides: 164 (High) 164. On 10-Jul-2018, High density lipoprotein: 35 (Low) 35. On 10-Jul-2018, Low density lipoprotein: 43 (normal) 43. On 11-Jul-2018, Blood creatinine: 0.97 (normal) 0.97 mg/dl. On 12-Jul-2018, Blood creatinine: 0.95 (normal) 0.95 mg/dl.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 15 May 2018, adult BMI 40.0-44.9 kg/sq m. He had controlled Type 2 diabetes with circulatory disorder without long term current use of insulin (Chronic). On Sep 2015 he underwent sigmoid colon resection. On 07 Oct 2015, ICD-10-CM of CAD with angina pectoris was I25.119 and priority was low. On 08 Oct 2015, his s/p previous single LIMA to LAD CABG. His circumflex and RCA were free of significant disease. On 01 Dec 2015, ICD-10-CM of benign non-nodular prostatic hyperplasia with lower urinary tract symptoms was N40.1 and priority was low. On 2016 patient had a growing irritating neck cyst which he wanted to remove. 0n 02 Jun 2016,  ICD-10-CM of bilateral chronic knee pain was M25.561, M25.562, G89.29 and priority was low. On 0   6 Nov 2016, patient visited ED for 2 day history of low grade fever, malaise, cough productive of tan sputum and was diagnosed with CAP. Had no fever, chills and appetite returned. On May 2017, patient had resected left parotid tumor and pathology revealed pleomorphic adenoma (benign mixed tumor) and on Oct 2017, patient had small laceration on left leg from running up against some aluminum. He kept it clean and dressed, however should have received a suture as it was slightly open and healed by secondary intension. Concomitant medication include ACE inhibitor. Patient has no current chest pain or dyspnea symptoms despite being active. ICD-10-CM of pulmonary hypertension was I27.20, aneurysm was I72.9 and ventricular tachycardia was I47.2, and priority were low for all. No treatment information was provided. Company comment: This spontaneous case concerns a 68-year-old female, with relevant concurrent medical condition of Essential hypertension (since 15-Oct-2015) and Unstable angina (since 27-Aug-2020), who experienced unexpected serious AESI event of ventricular tachycardia and unexpected serious event of pulmonary hypertension (seriousness criteria medically significant), which occurred 28 days after the first dose of mRNA-1273 vaccine. Patient's relevant concurrent medical condition of Essential hypertension and Unstable angina remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-526147, MOD-2022-503788.; Sender's Comments: This spontaneous case concerns a 68-year-old female, with relevant concurrent medical condition of Essential hypertension (since 15-Oct-2015) and Unstable angina (since 27-Aug-2020), who experienced unexpected serious AESI event of ventricular tachycardia and unexpected serious event of pulmonary hypertension (seriousness criteria medically significant), which occurred 28 days after the first dose of mRNA-1273 vaccine. Patient's relevant concurrent medical condition of Essential hypertension and Unstable angina remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.