Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | — | IM |
A fib with rapid ventricular rate; Acute decompensated heart failure; This 74-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 27-AUG-2021, for prophylaxis. The subject's past medical history included myocardial infarction. Concurrent medical conditions included ischemic heart disease, atrial fibrillation, hypertension, congestive heart failure, hypercholesterolemia, coronary artery disease and type ii diabetes mellitus. Concomitant products included acetylsalicylic acid (Aspirin), rivaroxaban (Xarelto), spironolactone, pravastatin, metoprolol, metformin, glimepiride, furosemide and insulin glargine (Insulin Lantus). In 2022, less than 2 years after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 acute decompensated heart failure (Verbatim: Acute decompensated heart failure). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 atrial fibrillation with rapid ventricular response (Verbatim: A fib with rapid ventricular rate) on 15-SEP-2022 with serious criteria of hospitalization. The outcome of acute decompensated heart failure was resolved on 25-SEP-2022. The outcome(s) of the additional event(s) included atrial fibrillation with rapid ventricular response (resolved on 25-SEP-2022). Diagnostic results (reference ranges are provided in parenthesis if available): Blood creatinine-In SEP-2022 3.3. Troponin-In SEP-2022 elevated. The investigator considered that there was no reasonable possibility that the acute decompensated heart failure and atrial fibrillation with rapid ventricular response may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the acute decompensated heart failure and atrial fibrillation with rapid ventricular response may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2021GSK239453, US2022150567 GSK Receipt Date: 22-SEP-2022 Subject was admitted 15 SEP 2022 through 25 SEP 2022 His primary admitting diagnosis was acute decompensated heart failure and secondary diagnosis was atrial fibrillation with rapid ventricular rate. He presented 15 SEP to the hospital with progressive shortness of breath for approximately 10 days. He hadn't been taken Lasix for approximately 10 days and had subsequently gained 7 lbs. He was found to have an elevated troponin but there was no concern for acute MI during this hospitalization. he was found to have atrial fibrillation with rapid ventricular rate and was started on Amiodarone (discontinued due to intolerance by subject) Had a right heart catheterization that demonstrated elevated right sided filling pressures. Developed AKI (creatinine peaked at 3.3) during hospitalization. Acute decompensation of heart failure, afib, and AKI resolved prior to discharge 25 Sep 2022, and he was discharged in stable condition. Follow-up information received on 28-Sep-2022, 29-Sep-2022 this follow-up was consider significant. Summary of changes: event outcome updated Follow-up information received on 19-OCT-2022. Summary of changes: event term and onset date of event were updated. Follow-up information received on 21-OCT-2022. Summary of changes: Investigator text updated. Follow-up information received on 26-OCT-2023, 27-OCT-2023 and 31-OCT-2023. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Summary of changes: Medical history and concomitant medications added. Lab data updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of atrial fibrillation and Cardiac failure acute, 384 days after receiving 1st dose of RSVPreF3 in a 74-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, alternative risk factors (ischemic heart disease, hypertension, congestive heart failure, coronary artery disease and type ii diabetes mellitus) and alternate etiology (known atrial fibrillation) based in medical history. US-GSK-US2021GSK239453: US-GSK-US2022150567:
Atrial fibrillation; Congestive heart failure; Coronary artery disease; Hypercholesterolemia; Hypertension; Ischemic heart disease; Type II diabetes mellitus
Medical History/Concurrent Conditions: Myocardial infarction
ASPIRIN; XARELTO; SPIRONOLACTONE; PRAVASTATIN; METOPROLOL; METFORMIN; GLIMEPIRIDE; FUROSEMIDE; INSULIN GLARGINE
Test Date: 202209; Test Name: creatinine; Result Unstructured Data: (Test Result:3.3,Unit:unknown,Normal Low:,Normal High:); Test Date: 202209; Test Name: troponin; Result Unstructured Data: (Test Result:elevated,Unit:unknown,Normal Low:,Normal High:)