Age: 63.0
Sex: M
Vaccine: FLUX, RSV
Symptoms: Atrial fibrillation, Cardioversion, Condition aggravated, Heart rate irregular, Pyrexia
Clinical narrative: Patient also experienced a fever after coming home from the emergency department.; Patient had a diagnosis of A-Fib prior to receiving vaccine; This serious case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation aggravated in a 63-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   The patient's past medical history included open heart surgery (Open heart surgery (age 35)). Concurrent medical conditions included atrial fibrillation (A-Fib (4 years ago during stress test)). Concomitant products included metoprolol, paracetamol (Acetaminophen), prasugrel and apixaban (Eliquis).   On 26-JAN-2024, the patient received Arexvy and Influenza vaccine. On 26-JAN-2024, 4 hrs after receiving Arexvy and Influenza vaccine, the patient experienced atrial fibrillation aggravated (Verbatim: Patient had a diagnosis of A-Fib prior to receiving vaccine) (serious criteria GSK medically significant). On 27-JAN-2024, the patient experienced fever (Verbatim: Patient also experienced a fever after coming home from the emergency department.). The patient was treated with magnesium and paracetamol (Tylenol). The outcome of the atrial fibrillation aggravated and fever were resolved.   It was unknown if the reporter considered the atrial fibrillation aggravated and fever to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation aggravated and fever to be related to Arexvy.   Additional Information: GSK Receipt date: 29-JAN-2024 The patient self-reported this case for himself. The patient received an AREXVY vaccine with a flu vaccine at his pharmacy.  The patient did not receive a card with vaccine information from pharmacy and was unable to provide lot numbers.  The patient had a diagnosis of A-Fib prior to receiving vaccine. The patient reported, approximately 4 hours after receiving his vaccines he experienced mild A-Fib.  Then during the night the A-Fib became worse. Reporter has a smart watch that monitors his heart rate. The patient stated that his heart rate was jumping from 70 bpm to 37 bpm then back up to 70 bpm.  A-Fib was not resolving.  Approximately 4-5am in the morning patient went to the hospital emergency department. While in the emergency department patient reports he was given Magnesium to relax his heart which was unsuccessful.  The patient  reported, after the unsuccessful magnesium treatment the hospital HCP cardio-shocked his heart into normal rhythm.  The patient was not admitted to the hospital and was discharged from the emergency department approximately 2pm in the afternoon.  The patient also experienced a fever after coming home from the emergency department. Fever occurred 1 day after vaccines were administered.  The patient reported,  the fever was brief and resolved quickly with Tylenol.  A-Fib and fever were resolved. The patient had an appointment with his Cardiologist.  The reporter consented to follow. It was unknown if the reporter considered the atrial fibrillation aggravated and fever to be related to Influenza vaccine