Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM |
atrial fibrillation; This 64-year-old male subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) .5 ml on 15-APR-2021, for prophylaxis. On 12-OCT-2022, 545 days after receiving RSVPreF3 vaccine + AS01E, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: atrial fibrillation). Serious criteria included hospitalization. The action taken with RSVPreF3 vaccine + AS01E was no change. The outcome of atrial fibrillation was resolved on 13-OCT-2022. The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. Linked case(s) involving the same subject: US2021216613 GSK receipt date: 14-Oct-2022 Subject was taken to the ER (emergency room) and admitted on 12Oct2022 due to a work injury and diagnosed with atrial fibrillation. Subject discharged to home 13OCT2022 to follow up with PCM (Patient-Centric Mobile). This was an AESI. Follow up information received on 14-DEC-2022. Summary of changes: Investigator text updated. Follow up information received on 10-JUL-2024 Summary of changes: General narrative comments were updated. Follow up information received on 18-JUL-2024 Summary of change : Narrative updated. Upon internal review case was updated on 22-Jul-2024, AESI sentence was added. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Summary of change : Analysis tab was updated. Follow up information received on 15-Aug-2024 Summary of change: General narrative comment updated.; Sender's Comments: A case of Atrial fibrillation, 545 days after receiving 1st dose of RSVPreF3 vs Placebo, in a 64-year old male subject .Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factor (Hypertension) as per linked case. US-GSK-US2021216613: