Received Jun 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
faint/quickly awake/be unstable/not aware of what is going on and sleep for x hours; A-Fib; chills; This is a spontaneous report received from a Consumer or other non HCP. An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Heart arrhythmia" (unspecified if ongoing), notes: Heart; "syncope" (ongoing); "enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; SIMVASTATIN; DOXAZOSIN; VITAMIN D NOS; MELATONIN; MIRALAX. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Primary immunisation series complete; manufacturer unknown), for COVID-19 immunisation. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "faint/quickly awake/be unstable/not aware of what is going on and sleep for x hours"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "A-Fib"; CHILLS (non-serious), outcome "unknown". Clinical course: The reporter has a history of heart arrhythmia and syncope, and was more recently diagnosed with atrial fibrillation (AFib). Their current medications include Metoprolol, Losartan, Finasteride, Doxazosin, Simvastatin, and Eliquis. When the initial two COVID-19 vaccine doses were administered, the only side effects reported were chills and soreness in the arm. For the first few booster shots, fatigue was also experienced, typically beginning around 12 hours after the injection and resolving within 24 hours. However, starting approximately three years ago, a new pattern began to emerge. Around 12 hours post-vaccination, chills would set in, followed by an episode of fainting within the next 12 hours. Although consciousness was quickly regained, the individual would remain disoriented, unstable, and would then sleep for several hours. Since the diagnosis of AFib and the initiation of treatment with Losartan and Eliquis, a change has occurred: the interval between receiving the booster and experiencing a fainting episode has gradually increased. After the most recent booster, given in the fall, the fainting did not occur until nearly two and a half days later. Now in their eighties, the reporter remains committed to continuing with COVID-19 boosters. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500117105 same patient, different dose/events;US-PFIZER INC-202500117115 same patient and drug, different dose and events;US-PFIZER INC-202500117641 same patient, different dose/events;US-PFIZER INC-202500117116 same patient, different dose/events;
Syncope
Medical History/Concurrent Conditions: Arrhythmia (Heart); Enlarged prostate
METOPROLOL; SIMVASTATIN; DOXAZOSIN; VITAMIN D NOS; MELATONIN; MIRALAX