Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Echocardiogram, Electrocardiogram, Heart rate, Investigation
Clinical narrative: severe VTach; serious cardiac arrhythmias; right ventricle was enlarged; began to develop a dry cough; This is a spontaneous report received from a Nurse from medical information team, Program ID.  A 14-year-old male patient received BNT162b2 (BNT162B2), on 03Jul2021 as dose 2, single (Lot number: EW0217) at the age of 14 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "never smoked" (unspecified if ongoing), notes: Her son never smoked, vaped, or did drugs. There were no concomitant medications. Vaccination history included: BNT162b2 (Pfizer Covid-19 Vaccine first dose: , Lot: EW0168, Expiry: Unknown), administration date: 12Jun2021, when the patient was 14-year-old, for COVID-19 Immunization. The following information was reported: COUGH (non-serious) with onset Apr2024, outcome "not recovered", described as "began to develop a dry cough"; VENTRICULAR TACHYCARDIA (hospitalization, medically significant, life threatening) with onset 2024, outcome "unknown", described as "severe VTach"; ARRHYTHMIA (hospitalization, medically significant, life threatening), outcome "unknown", described as "serious cardiac arrhythmias"; RIGHT VENTRICULAR ENLARGEMENT (medically significant), outcome "not recovered", described as "right ventricle was enlarged ". The patient was hospitalized for arrhythmia (start date: 30Oct2024, discharge date: 15Nov2024, hospitalization duration: 17 day(s)). The events "serious cardiac arrhythmias" and "severe vtach" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) did not show anything; Cardiac monitoring: (unspecified date) Unknown results; Cardiac telemetry: (unspecified date) Unknown results; Chest X-ray: (unspecified date) did not show anything; Echocardiogram: (unspecified date) Unknown results; Electrocardiogram: (unspecified date) Unknown results; Heart rate: (unspecified date) 250; (unspecified date) higher; (unspecified date) 120; (unspecified date) 100's-110's; (unspecified date) 260; (unspecified date) worse; (06Aug2024) 250, notes: heart rate was beating out of his chest and his rate was 250; (15Aug2024) 250, notes: heart rate was beating out of his chest and his rate was 250; (unspecified date) heart racing 120's; His genetic testing: (unspecified date) shows nothing; Metabolic function test: (unspecified date) did not show anything. Therapeutic measures were taken as a result of arrhythmia, ventricular tachycardia, cough. Clinical course: The caller a consumer, calling in about his son and trying to get help because he had developed some serious cardiac arrhythmias as a result of taking the Pfizer Covid-19 vaccine. Since he got to the vaccine, he always ran a higher heart rate of 250 heart rate. The doctors do not know why he has developed the condition. Since he got the vaccine, he always ran a higher heart rate. The doctors do not know why he has developed the condition. Last year in Apr, he began to develop a dry cough and last year in Aug they didn't find anything but he was rushed to the emergency room with a heart rate of 250. She would like to know if it's the vaccine and wanted to report it as there are no answers as to why he has developed the condition, but they have speculated it could be the vaccine and she would like to see if it's related to the vaccine. Received the second dose of the Pfizer Covid-19 vaccine in Jul2021. Within a couple of months started having a higher heart rate. She asked the Nurse Practitioner if his heat rate was higher, it was around at 120. At home it was in the 100's-110's, but he had no symptoms. He is also a kid and they will not explain what is going on with him. They found out his right ventricle was enlarged when he was diagnosed with the cardiac arrhythmia and stated that it had been going on for a couple of years. He developed a cough for months but they did not pay attention to it and said that it was dry. It began to get worse. They prescribed in antibiotics and it did not do anything. Then it did not get any better and on 06Aug2024 he went back to the MD as the cough got worse and felt his heart racing all of the time. He could feel his heart racing 120's and it was not sustained and she would check his pulse at that time. He was sent for a EKG (electrocardiogram), chest x-ray, blood work, BMP (basic metabolic panel) and it did not show anything. This was on 06Aug2024. 15Aug2024 his heart rate was beating out of his chest and his rate was 250 and she took him to the ER (emergency room), and they had him on the monitor. He was tachycardic but did not have another event while at the hospital. He went home and was referred to a cardiologist. They ordered a Echocardiogram and an EKG (electrocardiogram) and cardiac monitor. He had a MCOT (Mobile Cardiac Outpatient Telemetry) monitor ordered for him. He never had the echo done because on 30Oct2024 his event monitor recorded severe tachycardia with sustained VTach. It was at least 45 seconds of sustained Vtach. Heart rate went over 260 on the monitor. Was taken to hospital emergency room and was admitted. Her son had no chest pain and mild sob, admitted he was having tachycardic episodes, but it would pass. He had a cardiac ablation on 04Nov2024. The procedure did not go well and took twice the length of time. They almost lost him in the procedure due to him going into severe VTach (ventricular tachycardia). During the procedure they were able to zap the faulty pathways in the heart, but they realized that they had jumped to the outside of the heart. The procedure had gone on so long they decided not to go into the chest to zap the outside of the heart because his condition was critical. He was brought to cardiac stepdown and went into VTach (ventricular tachycardia) and stayed in the cardiac ICU for a full week.  Her son was sent home on 80mg Sotalol and it is really taking a toll on him. Went home with a heart monitor for a month. His doctor's can't find a reason for the arrythmias. His genetic testing shows nothing.; Sender's Comments: Based on the information available and plausible temporal association, the causal relationship between the reported serious events VENTRICULAR TACHYCARDIA ,  RIGHT VENTRICULAR ENLARGEMENT , ARRHYTHMIA and suspect drug BNT162B2 cannot be 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate