Received May 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Asked if the caller has any comorbidities or immunocompromised, caller stated that he has a pace maker, TAVR aortic valve replacement; Asked if the caller has any comorbidities or immunocompromised, caller stated that he has a pace maker, TAVR aortic valve replacement; This is a spontaneous report received from a Physician from medical information team, Program ID. A 75-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27Aug2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 5 (BOOSTER), SINGLE), administration date: 03Apr2022, for COVID-19 immunization; BNT162b2 (DOSE 6 (BOOSTER), SINGLE), administration date: 14Sep2023, for COVID-19 immunization; Moderna (DOSE 1, SINGLE), administration date: Jan2021, for COVID-19 immunization; Moderna (DOSE 2, SINGLE), administration date: Feb2021, for COVID-19 immunization; Moderna (DOSE 3 (BOOSTER), SINGLE), administration date: Aug2021, for COVID-19 immunization; Comirnaty (DOSE 4 (BOOSTER), SINGLE), administration date: Mar2022, for COVID-19 immunization. The following information was reported: AORTIC VALVE REPLACEMENT (medically significant), CARDIAC PACEMAKER INSERTION (medically significant), outcome "unknown" and all described as "Asked if the caller has any comorbidities or immunocompromised, caller stated that he has a pace maker, TAVR aortic valve replacement". Clinical course: Caller is a HCP and a patient, confirmed above inquiry. His last dose of COVID-19 vaccine was on 27Aug2024 which was the Comirnaty 12 plus. Asked if the caller has any comorbidities or immunocompromised, caller stated that he has a pace maker, (withheld) valve replacement. Caller also stated that he had a total of 7 covid-19 vaccinations. He is 75 years old turning 76. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Based on known nature of the events and limited information available, the events are assessed as not related to BNT162b2 omicron (kp.2), and more likely due to underlying medical conditions. 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.