Sex: F
Vaccine: COVID19
Symptoms: Cardiac electrophysiologic study, Cardiac monitoring, Cardiac stress test, Cardiac telemetry, Echocardiogram
Clinical narrative: VENTRICULAR TACHYCARDIA; This is a literature report .  A 40 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation.  The following information was reported: VENTRICULAR TACHYCARDIA (hospitalization, medically significant), outcome "recovered", described as "VENTRICULAR TACHYCARDIA". The event "ventricular tachycardia" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: cardiac electrophysiologic study: revealing vpds localized to the rvot; excluded other arrhythmias; cardiac monitoring: revealed no further vt; cardiac stress test: achieving > 85% age predicted, notes: heart rate without arrhythmia 7 weeks later; cardiac telemetry: sinus rhythm with symptomatic inferiorly directed, notes: sinus rhythm with symptomatic inferiorly directed ventricular premature depolarizations (VPDs); echocardiogram: normal; heart rate: 240, notes: Unit: bpm tachycardia; laboratory test: unremarkable; magnetic resonance imaging: normal; troponin i (0.017-0.056): 0.427 ng/dL, notes: peaked. Therapeutic measures were taken as a result of ventricular tachycardia. Clinical course: The patient is a 40-year-old woman with no history of heart disease or anxiety presenting with palpitations and syncope two days after receiving the second dose of the Pfizer BNT162b2 mRNA COVID-19 vaccine. She felt well prior to symptom onset. She was found by emergency services to be minimally responsive in a wide complex tachycardia at 240 bpm requiring cardioversion. On arrival she was well appearing without notable exam findings. Laboratory assessment was unremarkable. Telemetry revealed sinus rhythm with symptomatic inferiorly directed ventricular premature depolarizations (VPDs). Decision-making: A lidocaine drip and oral metoprolol tartrate were initiated. Echocardiography and cardiac magnetic resonance were normal. Troponin I peaked at 0.427ng/dl (0.017-0.056). The patient underwent electrophysiology study (EPS) revealing VPDs localized to the RVOT. VT was not inducible. Ablation was performed with termination of VPDs following the first lesion. EPS excluded other arrhythmias. Given the patient's lack of inducibility despite stimulation, implantable cardioverter defibrillator was deferred. 30-day rhythm monitor revealed no further VT. She completed exercise stress testing achieving > 85% age predicted heart rate without arrhythmia 7 weeks later and is asymptomatic 6 months post ablation. The reported conclusion was hemodynamically unstable RVOT VT soon after the second dose of COVID-19 vaccination, effectively treated with catheter ablation. RVOT VT is not uncommon in structurally normal hearts but is rarely hemodynamically unstable. Recent reports link COVID vaccination and myocardial inflammation, but the incidence of VT remains exceedingly low. The patient had no antecedent risks or symptoms and the temporal relationship with vaccination was present. The benefits of COVID-19 vaccination outweigh risks; however, palpitations post vaccine may warrant further workup.; Sender's Comments:  Based on the current available  information and the plausible drug-event association, a possible contributory role of the suspect product BNT162B2 to the development of the event Ventricular tachycardia cannot be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.