Symptomtext
Sustained ventricular heart arrhythmia; bigeminy of PVCs; shortness of breath with mild exertion; palpitations; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 19:15 (Lot number: 301U58A) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (received within 2 weeks of vaccination) included: MYRBETRIQ; OMEPRAZOLE; AMBIEN; ALLEGRA; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Erythromycin, reaction(s): "known allergies: erythromycin". The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The following information was reported: VENTRICULAR ARRHYTHMIA (medically significant) with onset 08Oct2021 13:00, outcome "not recovered", described as "Sustained ventricular heart arrhythmia"; VENTRICULAR EXTRASYSTOLES (non-serious) with onset 08Oct2021 13:00, outcome "not recovered", described as "bigeminy of PVCs"; DYSPNOEA EXERTIONAL (non-serious) with onset 08Oct2021 13:00, outcome "not recovered", described as "shortness of breath with mild exertion"; PALPITATIONS (non-serious) with onset 08Oct2021 13:00, outcome "not recovered", described as "palpitations". The events "sustained ventricular heart arrhythmia", "bigeminy of pvcs", "shortness of breath with mild exertion" and "palpitations" were evaluated at the physician office visit. Since the vaccination, the patient has been tested for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Oct2021) negative. Therapeutic measures were taken as a result of ventricular arrhythmia, ventricular extrasystoles, dyspnoea exertional, palpitations. Clinical course: Within less than 48 hours of receiving the vaccine, the patient has developed a sustained ventricular heart arrhythmia where the patient is experiencing bigeminy of PVCs, palpitations and shortness of breath with mild exertion. The patient is seeing a cardiologist now. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is 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.