Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | — | IM |
Atrial Fibrillation (not exacerbation); This 67-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 21-JUL-2021, for prophylaxis. Co-suspect products included clopidogrel bisulfate (Plavix) for coronary artery disease. On 28-JAN-2023, 556 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: Atrial Fibrillation (not exacerbation)). Serious criteria included hospitalization. The outcome of atrial fibrillation was resolved on 30-JAN-2023. The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. Other possible cause(s) of the atrial fibrillation included concurrent medication. 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: US2023GSK014869 GSK receipt date: 30-jan-2023 Subject reports he had an Atrial Fibrillation on 28 Jan 2023 and was hospitalized that same night. Subject was still under observation and mentions his physician stated that his medications might have caused this event. Subject was discharged from hospital on 30 Jan 2023. Subject reports he was told to stop taking Plavix. Follow-up information received on 06-Feb-2023. Summary of changes: Action taken updated, Study medication start date, dose number and TTO updated. Follow-up information received on 14-Feb-2023. Summary of changes: event outcome and outcome date was updated. Follow-up information received on 03-MAR-2023. Summary of changes: SAE term updated from Atrial Fibrillation exacerbation to Atrial Fibrillation. Follow-up information received on 15-MAR-2023. Summary of changes: Narrative, hospital discharge date were updated. Follow-up information received on 21-Mar-2023. Summary of changes: Event verbatim updated. Follow-up information received on 28-NOV-2023. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Summary of changes: AESI sentence was updated. Follow-up information received on 04-DEC-2023 Summary of changes: General narrative comments were updated. Follow-up information received on 20-DEC-2023 Summary of changes: General Narrative comments updated. Follow-up information received on 03-JAN-2024 On 28-JAN-2023, 23 years after receiving Plavix, the subject developed moderate grade 2 atrial fibrillation. The investigator considered that there was reasonable possibility that the atrial fibrillation may have been caused by Plavix. Summary of Changes: New medication Plavix was added as cause of AE. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial fibrillation, 556 days after receiving 1st dose of RSVPreF3, in a 67-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative etiology (h/o concurrent medication clopidogrel bisulfate (Plavix) for coronary artery disease). US-GSK-US2023GSK014869:
PLAVIX