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 |
atrial fibrillation; This 72-year-old female subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 15-AUG-2022, for prophylaxis. Concurrent medical conditions included weakness and fatigue. On 22-AUG-2023, 372 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: atrial fibrillation). Serious criteria included hospitalization. The subject was treated with rivaroxaban (Xarelto). The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial fibrillation was not resolved. Relevant Tests: On 22 AUG 2023 12 Lead electrocardiogram (ECG) showed PR UNK, QRS 93, QTc 394 Ventricular Rate 115- Atrial fibrillation with RVR, nonspecific ST and T-wave abnormality, abnormal rhythm ECG. On 22 AUG 2023 Transesophageal echocardiogram (TEE) performed which revealed severely enlarged left atrium but no other vascular issues or clot formation, and underwent successful cardioversion back to sinus rhythm. 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. GSK receipt date: 30-Aug-2023 Subject admitted 8/22/23 with symptoms of fatigue and weakness and discharged 8/24/2023. Atrial Fibrillation will continue no stop date expected. Atrial Fibrillation continues. Atrial continues as of 05 Dec 2023. Atrial Fibrillation continues as of 9 Feb 2024. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow-up information received on: 05-Sep-2023 Summary of changes: Hospitalization details and Narrative updated. Follow-up information received on: 11-Sep-2023 Summary of changes: Concomitant drug, medical history, lab data added, narrative updated. Follow-up information received on 12-SEP-2023. Summary of changes: Type of drug was updated from concomitant to treatment. Follow-up information received on 14-SEP-2023. Summary of changes: Narrative updated. Follow-up information received on 20-NOV-2023. Summary of changes: Action taken not applicable changed to dose not changed. Follow-up information received on 30-NOV-2023 and 05-DEC-2023 Summary of changes: General narrative comments were updated. Follow-up information received on 19-FEB-2024. Summary of changes: General narrative comment updated. Follow up information received on 04-Jul-2024, End of study Unblinding completed; Sender's Comments: A case of Atrial fibrillation, 795 days after receiving 2nd dose of RSVPreF3 in a 72-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset.
Fatigue; Weakness
Comments: On 22 AUG 2023 12 Lead electrocardiogram (ECG) showed PR UNK, QRS 93, QTc 394 Ventricular Rate 115- Atrial fibrillation with RVR, nonspecific ST and T-wave abnormality, abnormal rhythm ECG. On 22 AUG 2023 Transesophageal echocardiogram (TEE) performed which revealed severely enlarged left atrium but no other vascular issues or clot formation, and underwent successful cardioversion back to sinus rhythm