Received Apr 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
feeling like her heart rate was all over the place; Atrial Fibrillation; PROGRAM This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. A 71-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa Antibiotics" (unspecified if ongoing). Concomitant medication(s) included: ALPRAZOLAM; FULVESTRANT; OXYCODONE AND ACETAMINOPHEN; METOPROLOL TARTRATE. Past drug history included: Anastrozole, reaction(s): "Drug allergy"; Duloxetine hcl, reaction(s): "Drug allergy"; Lidocaine, reaction(s): "Drug allergy"; Pregabalin, reaction(s): "Drug allergy"; Prochlorperazine, reaction(s): "Drug allergy"; Sulfamethoxazole-trimethoprim, reaction(s): "Drug allergy"; Sulfur, reaction(s): "Drug allergy"; Haloperidol, reaction(s): "Drug allergy". The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset Mar2026, outcome "recovered"; HEART RATE ABNORMAL (non-serious), outcome "recovered", described as "feeling like her heart rate was all over the place". Therapeutic measures were taken as a result of atrial fibrillation, heart rate abnormal. Clinical course: She was diagnosed with atrial fibrillation last month after experiencing sensations of an irregular and fluctuating heart rate. She was prescribed Eliquis (apixaban) and metoprolol. She attributed the onset of AFib to a recently administered COVID-19 vaccine, stating that she is sensitive to vaccines, and did not believe the condition was related to Ibrance. The reporter considered "atrial fibrillation" related to BNT162b2 omicron (lp.8.1). The reporter's assessment of the causal relationship of "feeling like her heart rate was all over the place" with the suspect product(s) BNT162b2 omicron (lp.8.1) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: Although it is difficult to establish temporal association between reported events Atrial fibrillation, Heart rate abnormal and suspect drug based on the limited information provided in the case, the causal association between the Reported events and the suspect drug cannot be excluded as there is no concrete evidence available to eliminate the causal association. 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.
Medical History/Concurrent Conditions: Sulfonamide allergy
ALPRAZOLAM; FULVESTRANT; OXYCODONE AND ACETAMINOPHEN; METOPROLOL TARTRATE