Received Jan 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | UNK | IM / LA |
Atrial Flutter; This 79-year-old female subject was enrolled in an open label study The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, left deltoid) 120 µg on 07-APR-2025, for prophylaxis. On 04-AUG-2025, 119 days after receiving RSVPreF3 vaccine + AS01E, the subject developed moderate - grade 2 atrial flutter (Verbatim: Atrial Flutter). Serious criteria included hospitalization. The subject was treated with apixaban (Eliquis) and metoprolol tartrate. The outcome of atrial flutter was not resolved. The investigator considered that there was no reasonable possibility that the atrial flutter may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the atrial flutter may have been caused by RSVPreF3 vaccine + AS01E. GSK Receipt Date: 17-OCT-2025 Participant reported hospitalization sometime in early AUG-2025 for Atrial Flutter. Participant reported that she was discharged after a one day. Follow up PCP (Primary care physician) appointment on 23-AUG-2025 where subject was prescribed Eliquis 5 mg BID and Metoprolol tartrate 25 mg BID. Participant would follow up with cardiology this month. Participant was admitted to medical center and- records were requested to determine if any further reporting was required. Hospital Admission date of AE: 04-AUG-2025 Hospital Discharge date of AE: 05-AUG-2025 Date event became serious: 04-AUG-2025 Follow-up information received on 20-OCT-2025 Summary of changes: Narrative updated. Follow-up information received on 22-DEC-2025 Summary of changes: Event start date, outcome, date event became serious, hospitalization dates added. Follow-up information received on 14-JAN-2026 Summary of changes: AESI status updated yes to no and narrative updated.; Sender's Comments: A case of Atrial flutter, 119 days after receiving 1st dose of RSVPreF3 vaccine + AS01E, in 79-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausability.