Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | IM |
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | — | IM |
New Onset Atrial Fibrillation; This 62-year-old male subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 12-SEP-2022, for prophylaxis. Concurrent medical conditions included hypercholesterolemia, hypertension, atrial flutter and type ii diabetes mellitus. Concomitant products included amlodipine, rosuvastatin calcium (Crestor) and carvedilol. On 18-AUG-2023, 340 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: New Onset Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with apixaban (Eliquis). The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial fibrillation was not resolved. Diagnostic results (reference ranges are provided in parenthesis if available): Heart rate-In AUG-2023 240 (maximum) bpm. The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2023115567 GSK receipt date: 21-AUG-2023 Visit 5NH 21AUG2023 - Per PI: subject reported being diagnosed, hospitalized, and treated via Ablation around a year ago despite office visit in SEP 2022 and a year of phone contacts. He was just now reporting this diagnosis because of another Ablation performed on 18AUG2023. Subject had very little details, records requested for these details into diagnosis and treatment. Would update upon record receipt Subject was a 62 year old male with a history of diabetes mellitus type 2, hypertension, and hypercholesterolemia who presented to the office for visit 5 on 21AUG2023. At that time, he informed the site that he had been treated for atrial fibrillation since spring of 2022. On review of requested medical records, he was diagnosed with atrial flutter by a cardiac electrophysiologist. No treatment started secondary to arrythmia spontaneously converted. Through July and August of 2023, subject was evaluated for recurrent symptoms with placement of intracardiac loop recorder. This demonstrated numerous atrial fibrillation and atrial flutter events with 30 events of greater than 6 hours, maximum heart rate 240 bpm. The decision was made to perform an ablation for atrial fibrillation on 18AUG2023. Subject was admitted overnight for monitoring. Discharge medications updated to include Eliquis 5 mg BID, Carvedilol 12.5 mg BID, Crestor 20 mg QD, and Amlodipine 5 mg BID. Discharged 19AUG2023 Update per query 25JUN2024 - Subject was still taking the above medications started 19AUG2023, no further intervention needed as of end of study visit on 06MAY2024. Because ongoing medication, condition was considered not recovered/ not resolved. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow up information received on 24-Aug-2023. Summary of changes: Subject age updated. Vaccination date and dose number updated. TTO updated. Lab data and narrative updated. Follow up information received on 28-Aug-2023, 29-Aug-2023. Summary of change: Event onset date and TTO updated, concomitant and treatment medications added. Current medical conditions added. Discharge date added, narrative updated. Follow up information received on 31-Aug-2023. Summary of changes: medical history, Lab data and narrative updated. Follow up information received on 14-sep-2023 Summary of change: Start date of Carvedilol updated. Follow up information received on 25-JUN-2024 Summary of change: General narrative were updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial fibrillation, 718 days after receiving 1st dose of RSVPreF3 in a 62-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factors (h/o atrial flutter, hypertension, type ii diabetes mellitus, acute kidney injury and hypercholesterolemia) based on medical historyk and as per linked cases. US-GSK-US2023115565: US-GSK-US2023115567:
Atrial flutter; Hypercholesterolemia; Hypertension; Type II diabetes mellitus
AMLODIPINE; CRESTOR; CARVEDILOL
Test Date: 202308; Test Name: heart rate; Result Unstructured Data: (Test Result:240 (maximum),Unit:bpm,Normal Low:,Normal High:)