Received Aug 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 3 | UNK | IM |
sick sinus syndrome; Intermittent Syncope; Atrial Fibrillation; This 79-year-old male subject was enrolled in an open label study titled A phase 3, randomized, open-label, multi-country study to evaluate the immunogenicity, safety, reactogenicity and persistence of a single dose of the RSVPreF3 OA investigational vaccine and different revaccination schedules in adults aged 60 years and above. The subject received the 3rd dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) 120 µg on 19-APR-2023, for prophylaxis. In DEC-2023, between 7 and 9 months after receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 atrial fibrillation (Verbatim: Atrial Fibrillation). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 sick sinus syndrome (Verbatim: sick sinus syndrome) in DEC-2023 with serious criteria of hospitalization and moderate - grade 2 syncope (Verbatim: Intermittent Syncope) in DEC-2023 with serious criteria of hospitalization. The outcome of atrial fibrillation was not resolved. The outcome(s) of the additional event(s) included sick sinus syndrome (resolved in FEB-2024) and syncope (resolved in APR-2025). Relevant Tests: On Unk/Dec/2023, Subject reported a brain MRI (Magnetic resonance imaging) showed 2 posterior vessels were obstructed.. The investigator considered that there was no reasonable possibility that the atrial fibrillation, sick sinus syndrome and syncope may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the atrial fibrillation, sick sinus syndrome and syncope may have been caused by RSVPreF3 vaccine + AS01E. Linked case(s) involving the same subject: US2024051986, US2025100252 GSK receipt date: 23-Apr-2024 Hospital records pending Hospital records still pending as of 5/28/2024 Subject admitted to hospital for syncope. In February 2024, he had atrial fibrillation and a sick sinus syndrome for which a pacemaker was placed 14FEB2024. This was an AESI. 6/19/2024: Hospital records had not been received. Intermittent Syncope began unDEC2023 for which he was treated for as well during hospitalization. 11/13/2024: Hospital records had not been received. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow up information received on 07-MAY-2024 Summary of change : Narrative updated. Follow up information received on 28-MAY-2024 On 28-May-2024, the case US2024051986 was identified as duplicate of US2024051985. The case US2024051986 was prepared for deletion and all future correspondence will be added to the case US2024051985. Summary of change : Narrative updated, Event term updated from Atrial Fibrillation to Atrial Fibrillation and Intermittent Syncope Follow-up information received on :- 10-Jul-2024 Summary of changes:- SAE term updated to Atrial Fibrillation from Atrial Fibrillation and Intermittent Syncope. AESI sentence updated in narrative. Follow up information received on 18 Jul 2024 and 19 Jul 2024 Summary of changes: General narrative was updated. Follow up information received 25-JUL-2024 Summary of changes: New events sick sinus syndrome, Intermittent Syncope and narrative updated. Follow up information received 18-Sep-2024. Summary of changes: "The subject withdraw from study due to event of Atrial Fibrillation" sentence removed and narrative was updated. Follow up information received 13-NOV-2024 Summary of changes: General narrative was updated. Follow up information received on 04-Aug-2025. Summary of changes: Outcome of events sick sinus syndrome and intermittent syncope updated from not recovered to recovered.; Sender's Comments: A case of Atrial fibrillation, Sinus node dysfunction and Syncope, between 7 and 9 months after receiving 3rd dose of RSVPreF3 vaccine + AS01E in a 79-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factor for atrial fibrillation and sinus node dysfunction (age) and (brain MRI showed 2 posterior vessels were obstructed) for event syncope. US-GSK-US2024051986: US-GSK-US2025100252:
Comments: On Unk/Dec/2023, Subject reported a brain MRI (Magnetic resonance imaging) showed 2 posterior vessels were obstructed.