Received Feb 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
ventricular tachycardia; uncontrollable hypertension; This is a spontaneous report received from a Physician from medical information team. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VENTRICULAR TACHYCARDIA (medically significant), outcome "unknown"; HYPERTENSION (medically significant), outcome "unknown", described as "uncontrollable hypertension". Therapeutic measures were taken as a result of ventricular tachycardia, hypertension. The patient was the reporter's colleague who had received the COVID-19 vaccine and had similar symptoms...uncontrollable hypertension and ventricular tachycardia. He had a pacemaker placed. Despite that, the patient and reporter both agree that having the vaccine was critical. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Limited information precludes a comprehensive causality assessment, however based on the implied temporal association, the contributory role of suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded for the reported events. Information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. 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.