Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Autonomic nervous system imbalance, Cardiovascular disorder, Conduction disorder, Postural orthostatic tachycardia syndrome
Clinical narrative: Cardiac arrythmias and abnormalities conduction with significant fluctuations of the rhythm/ cardio related adverse events; Cardiac arrythmias and abnormalities conduction with significant fluctuations of the rhythm/ cardio related adverse events; autonomic nervous system effects; cardiovascular serious reactions to COVID vaccine; Postural orthostatic tachycardia syndrome (POTS); This is a spontaneous report and received from Pharmacists from medical information team.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 06May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single), administration date: 15Apr2021, for COVID-19 immunisation. The following information was reported: ARRHYTHMIA (hospitalization, medically significant), CONDUCTION DISORDER (hospitalization, medically significant), outcome "not recovered" and all described as "Cardiac arrythmias and abnormalities conduction with significant fluctuations of the rhythm/ cardio related adverse events"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (hospitalization), outcome "unknown", described as "autonomic nervous system effects"; CARDIOVASCULAR DISORDER (medically significant), outcome "unknown", described as "cardiovascular serious reactions to COVID vaccine"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), outcome "unknown", described as "Postural orthostatic tachycardia syndrome (POTS)". The events "cardiac arrythmias and abnormalities conduction with significant fluctuations of the rhythm/ cardio related adverse events" and "autonomic nervous system effects" required emergency room visit. Therapeutic measures were taken as a result of arrhythmia, conduction disorder. Clinical course: The patient, that had 2 Pfizer COVID-19 vaccines both in 2021, and patient was experiencing adverse events and apparently the ambulance was at this patient's house 3 to 4 times a week. Upon follow up on 27Feb2024, it was reported that adverse events started shortly after patient received the 2nd vaccine. Family Medical History Relevant to Adverse Events (AEs) was Unknown. Patient has not had any prior vaccines in the 4 weeks leading to the COVID Vaccine. She has had no prior illnesses, no comorbidity prior to getting the vaccines, was getting no medical therapies, whatsoever. Three, since getting the vaccines which they have got the history of hospitalization in for that, the initial side effects was Cardiac arrythmias and abnormalities conduction with significant fluctuations of the rhythm. She was on Metoprolol to try to control the rhythm, which was not completely successful but the cardiac side effects then progressed into autonomic nervous system effects which they had a tremendous difficulty in controlling. In addition, she said multiple other side effects transpiring over time. She also has a condition, called POTS (not clarified further). So, she was also addressing that with her.  Causality assessment: Source of assessment was Primary Source Reporter, Method of assessment: Global Introspection and Result of Assessment was Yes for description 'cardio related adverse events'.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Limited information provided precludes a comprehensive causality assessment; however based on the implied temporal association, the contributory role of suspect vaccine BNT162b2 cannot be completely excluded for the reported events of Arrhythmia, Conduction disorder, Autonomic nervous system imbalance, Cardiovascular disorder and Postural orthostatic tachycardia syndrome. The detailed clinical course with patient complete medical history would be helpful for further assessment. This case will be reassessed should additional information becomes available. 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.,Linked Report(s) : US-PFIZER INC-202400054289 Same reporter/drug/events, Different patient.;US-PFIZER INC-202400054269 Same reporter/drug/events, Different patient.;