Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: PAC/Arrhythmia, Palpitations,Pulse irregular; PVC/Arrhythmia, Palpitations,Pulse irregular; High fever; Covid; This spontaneous case was reported by a patient and describes the occurrence of SUPRAVENTRICULAR EXTRASYSTOLES (PAC/Arrhythmia, Palpitations,Pulse irregular) and VENTRICULAR EXTRASYSTOLES (PVC/Arrhythmia, Palpitations,Pulse irregular) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On 07-May-2022, the patient experienced COVID-19 (Covid). On an unknown date, the patient experienced SUPRAVENTRICULAR EXTRASYSTOLES (PAC/Arrhythmia, Palpitations, Pulse irregular) (seriousness criterion medically significant), VENTRICULAR EXTRASYSTOLES (PVC/Arrhythmia, Palpitations, Pulse irregular) (seriousness criterion medically significant) and PYREXIA (High fever). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-May-2022 to 11-May-2022 for COVID-19, at a dose of 10 milligram twice a day. At the time of the report, SUPRAVENTRICULAR EXTRASYSTOLES (PAC/Arrhythmia, Palpitations, Pulse irregular), VENTRICULAR EXTRASYSTOLES (PVC/Arrhythmia, Palpitations, Pulse irregular) and COVID-19 (Covid) had resolved and PYREXIA (High fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 18-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Echocardiogram: determined to have pac, pvc Determined to have PAC, PVC. On an unknown date, Electrocardiogram: abnormal Abnormal. On an unknown date, Magnetic resonance imaging heart: determined to have pac, pvc Determined to have PAC, PVC.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. Patient experienced high fever, shortness of breath and patient still experiencing fatigue/slight fatigue, occasional dizziness. Event PAC, PVC and arrhythmia resolved on their own after several months. Patient was prescribed Paxlovid as a precaution primarily due to Cardiac issues in previous months.  Patient could play golf and walks 3 miles (4x weekly). It was stated that patient was not sure cardiac issues were result of vaccine.~ Patient received other drugs Shingrix on 02-May-2022 (Second Shingrix vaccine) and stopped and In Mar-2022, Escitalopram 5 mg daily and this was still ongoing. On 18-May-2022 patient was tested positive for Covid second time. Patient was not hospitalized due to the event and not received any treatment.  Company Comment:  This spontaneous case concerns a 68-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) adverse events of special interest Supraventricular extrasystoles, and Ventricular extrasystoles, and the unexpected, non-serious adverse event of special interest COVID-19. The events Supraventricular extrasystoles, and Ventricular extrasystoles occurred on an unknown date after, and the event COVID-19 occurred 7 months and 13 days after receiving third dose of mRNA-1273 vaccine. Patient presented with palpitations, fatigue, shortness of breath, and erratic pulses for which premature atrial contraction (PAC) and premature ventricular contractions (PVC) were diagnosed by a cardiologist after electrocardiogram, echocardiogram and cardiac magnetic resonance imaging were performed. The diagnosis of COVID-19 was supported by a SARS-CoV-2 test was positive.  Patient received a 2-dose primary series of mRNA-1273 vaccines given 28 days apart, with the last dose administered 7.5 months prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-590217 (Patient Link).; Sender's Comments: This spontaneous case concerns a 68-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) adverse events of special interest Supraventricular extrasystoles, and Ventricular extrasystoles, and the unexpected, non-serious adverse event of special interest COVID-19. The events Supraventricular extrasystoles, and Ventricular extrasystoles occurred on an unknown date after, and the event COVID-19 occurred 7 months and 13 days after receiving third dose of mRNA-1273 vaccine. Patient presented with palpitations, fatigue, shortness of breath, and erratic pulses for which premature atrial contraction (PAC) and premature ventricular contractions (PVC) were diagnosed by a cardiologist after electrocardiogram, echocardiogram and cardiac magnetic resonance imaging were performed. The diagnosis of COVID-19 was supported by a SARS-CoV-2 test was positive.  Patient received a 2-dose primary series of mRNA-1273 vaccines given 28 days apart, with the last dose administered 7.5 months prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.