Received Sep 11, 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 |
worsening of atrial fibrillation; This 76-year-old male subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 23-AUG-2022, for prophylaxis. The subject's past medical history included coronary stent placement and pneumothorax spontaneous. Concurrent medical conditions included anxiety, chronic obstructive pulmonary disease, ischemic heart disease, coronary artery disease, myocardial infarction, hyperlipidemia and atrial fibrillation. On 05-APR-2023, 225 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 atrial fibrillation aggravated (Verbatim: worsening of atrial fibrillation). Serious criteria included hospitalization. The subject was treated with metoprolol and apixaban (Eliquis). The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial fibrillation aggravated was resolved on 06-APR-2023. Relevant Tests: On 04-May-2023 ECG obtained: Done at 2136. Heart rate 167. ER doctor's interpretation, Regular, narrow complex tachycardia, likely atrial flutter with rapid ventricular response. Repeated at 2224.HR 96, Normal Sinus Rhythm.. Diagnostic results (reference ranges are provided in parenthesis if available): Heart rate-In APR-2023 significantly improved after Lopressor. Troponin-In APR-2023 normal. The investigator considered that there was no reasonable possibility that the atrial fibrillation aggravated may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial fibrillation aggravated may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2023071796 GSK receipt date: 19-MAY-2023 Spoke to subject yesterday for contact. During the call he mentioned that he had gone to the ER on 05APR2023 for an episode of atrial fibrillation to which he has a history of. He was admitted overnight. He was started on Eliquis 5mg. He was discharged on 06APR2023. He has followed up with his primary care physician who has continued the Eliquis and increased his dose of Metoprolol. Subject reports doing well. Will follow up once more information was received. As stated above, subject has a history of atrial fibrillation. Please advise if this event needs to report as an AESI. Site requested guidance from CRA but has not received any information at this time. Reporting as an SAE for safety. Per hospital records: labs obtained/reviewed-unremarkable, normal troponin. Heart rate significantly improved after Lopressor. He had one episode where his heart rate was back in the 120's but spontaneously converted back to sinus rhythm immediately. Subject reported significant improvement. Discharged home with cardiology follow up. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow up information received on 12-JUN-2023 Summary of changes: Relevant medical history, action taken of suspected drug and lab data has been updated. Follow-up information received on 16-Jun-2023. Previously investigator considered AE as Potential Immune Mediated Disease (pIMD) now it has been downgraded to NO. Summary of changes: Lab data and narrative updated. Follow-up information received on 29-FEB-2024. Summary of changes: Narrative updated. Follow-up information received on 10-MAY-2024. Summary of changes: Ongoing checked for treatment drugs Metoprolol and Eliquis. Follow up information received on 04-Jul-2024 End of study unblinding completed.; Sender's Comments: A case of Atrial fibrillation aggravated, 615 days after receiving 1st dose of RSVPreF3, in a 76-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factor (h/o known atrial fibrillation). US-GSK-US2023071796:
Anxiety; Atrial fibrillation; Chronic obstructive pulmonary disease; Coronary artery disease; Hyperlipidemia; Ischemic heart disease; Myocardial infarction
Medical History/Concurrent Conditions: Coronary stent placement; Pneumothorax spontaneous
Test Date: 202304; Test Name: Heart rate; Result Unstructured Data: (Test Result:significantly improved after Lopressor,Unit:unknown,Normal Low:,Normal High:); Test Date: 202304; Test Name: Troponin; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Comments: On 04-May-2023 ECG obtained: Done at 2136. Heart rate 167. ER doctor's interpretation, Regular, narrow complex tachycardia, likely atrial flutter with rapid ventricular response. Repeated at 2224.HR 96, Normal Sinus Rhythm.