Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | EW0171 | — |
Pfizer COVID vaccine created large hearts/have a pacemaker for an enlarged heart; passing out; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 19-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EW0153) and in 2021 as dose 2, single (Lot number: EW0171) at the age of 18 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIOMEGALY (medically significant) with onset 2021, outcome "unknown", described as "Pfizer COVID vaccine created large hearts/have a pacemaker for an enlarged heart"; LOSS OF CONSCIOUSNESS (medically significant) with onset 2021, outcome "unknown", described as "passing out". The events "pfizer covid vaccine created large hearts/have a pacemaker for an enlarged heart" and "passing out" required physician office visit. Therapeutic measures were taken as a result of cardiomegaly, loss of consciousness. Additional information: The patient previously had no medical issues, a healthy football player had to have a pacemaker. The patient was not on Pacemakers before receiving the Pfizer COVID vaccine, he was playing football, baseball and basketball and every other sport that could possibly think of, until he was told he had to take the vaccine to be able to go to school. The patient's mother reached out to a doctor in 2021 back when patient had his pacemakers put in and the doctor "don't know anything". The patient has a job in life and he just has a pacemaker. The patient was a healthy 18-year-old kid took the Vaccine and now, he has pacemaker enlarged heart, an 18-year-old healthy boy but then had to have a pacemaker for an enlarged heart. He had to have a pacemaker because of the vaccine. He got the vaccine (Pfizer COVID-19 Vaccine) and then started having symptoms which then required him to have a pacemaker installed. "They tried medication for him because he was passing out and they gave the option of putting in a pacemaker at that time but caller thought that was a little extreme, so did not do it and then, the medication did not really do the tricks, so then caller had to go in and get the pacemaker." No prior vaccination. No investigations.