Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 2 | — | IM |
Atrial Fibrillation; severe three vessel coronary artery disease; This 68-year-old male subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 20-SEP-2022, for prophylaxis. Concomitant products included carvedilol and amlodipine. On 05-MAY-2023, 227 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 triple vessel disease (Verbatim: severe three vessel coronary artery disease). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 atrial fibrillation (Verbatim: Atrial Fibrillation) on 23-MAY-2023 with serious criteria of hospitalization. The subject was treated with amiodarone and metoprolol. The action taken with RSVPreF3 vs Placebo was no change. The outcome of triple vessel disease was resolved on 18-MAY-2023. The outcome(s) of the additional event(s) included atrial fibrillation (resolved on 24-MAY-2023). Relevant Tests: On 05-MAY-2023; stress test showed left lower anterior descending coronary artery ligation. On an unknown date in 2023; Coronary Artery Bypass Graft x3. Diagnostic results (reference ranges are provided in parenthesis if available): Electrocardiogram-In MAY-2023 QTc was prolonged and in MAY-2023 QTc was improved. The investigator considered that there was no reasonable possibility that the triple vessel disease and atrial fibrillation may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the triple vessel disease and atrial fibrillation may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2023095341 GSK receipt date: 19-MAY-2023. Subject was seen by his cardiologist on 05 MAY 2023 for a stress test. He was scheduled for a heart catherization procedure on 15 MAY 2023. Subject's wife notified the site that he would be having bypass surgery on 18 MAY 2023. She contacted site to report that he had triple bypass surgery. Site would request hospital records upon subjects discharge and update accordingly. Site would also get updates from the subject's wife for any changes in condition. Subject was admitted to hospital on 5/18/23 and discharged home on 5/25/23. Still awaiting the hospital records. After numerous requests, hospital records were received on 11 JUL 2023. Event term was updated. During review of this event the subject was noted to have gone into atrial fibrillation on post op 5 while he was being prepared for discharge. Additional event had been noted for the atrial fibrillation. Spoke to subjects wife today 13 JUL 2023. She reported he was continuing to do well. We discussed medications noted in the hospital records. Site did not have 2 amlodipine 5 mg QD and carvedilol 3.125 mg BID captured in source/EDC. Questioned about diagnosis of hypertension. She indicated that he has had it since being diagnosed with hyperlipidemia. Med history and con med page updated. Reviewed ongoing post operative medications. He stopped the pain meds and muscle relaxer on 30 MAY 2023. Doctor stopped the potassium chloride and changed the dose of atorvastatin to 80 mg daily and metoprolol 12.5mg BID. Deleting Atrial Fibrillation as additional SAE(serious adverse event) and adding to this SAE(serious adverse event). Both events were in same hospitalization. Received and reviewed hospital medical records that were received on 11 JUL 2023. During review the subject was noted to have experience atrial fibrillation on post op day 5 (s/p coronary artery bypass graft x3). He was ready for discharge and had just had his chest tube removed we he went into atrial fibrillation. PICC line was placed and bolus of amiodarone was give and drip was started. On post op day 6 he converted back to normal sinus rhythm however his QTc was prolonged. Amiodarone was stopped and he was monitored for another day. Post op day 7 he remained hemodynamically stable in normal sinus rhythm and repeat ECG QTc was improved. He was discharged home with home health services. Admitted on 18 MAY 2023 and Discharged on 25 MAY 2023. Follow-up information received on 25-May-2023. Summary of changes: Narrative updated. Follow-up information received on 12-JUN-2023. Summary of changes: Hospitalization details and narrative updated. Follow-up information received on 10-JUL-2023. Summary of changes: Event term updated from coronary artery block to severe three vessel coronary artery disease. Follow-up information received on 11-JUL-2023 and 13-JUL-2023. Summary of changes: Relevant test and narrative updated. Follow-up information received on 14-JUL-2023. Summary of changes: Concomitant medications were updated. Follow-up information received on 30-OCT-2023. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). On 30/Oct/2023 case US2023095341 was identified as duplicate case of US2023071797. All the future correspondence will be added US2023071797. Summary of changes: Additional event Atrial fibrillation was added. General narrative comment updated. Metoprolol changed from concomitant to treatment medication. Upon internal review case was updated on 30-MAY-2024. Summary of changes: AESI statement was updated for AE atrial fibrillation. Start date for treatment drug metoprolol was updated from 23-JUN-2023 to 19-MAY-2023. Frequency of metoprolol was updated from BID to once daily. Treatment drug amiodarone was added. Narrative updated. Follow up information received on 12-Jun-2024. Summary of changes: Dosage regimen of metoprolol (start date: 22-Jun-2023) was deleted. Lab data and narrative updated. Follow up information received on 04-JUL-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial fibrillation and Coronary artery disease, 227 days after receiving the 2nd dose of RSVPreF3, in a 68-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility for the event Coronary artery disease and alternate etiology (h/o hypertension, hyperlipidemia) based on medical history. US-GSK-US2023095341:
CARVEDILOL; AMLODIPINE
Test Date: 202305; Test Name: ECG; Result Unstructured Data: (Test Result:QTc was prolonged,Unit:unknown,Normal Low:,Normal High:); Test Date: 202305; Test Name: ECG; Result Unstructured Data: (Test Result:QTc was improved,Unit:unknown,Normal Low:,Normal High:); Comments: On 05-MAY-2023; stress test showed left lower anterior descending coronary artery ligation. On an unknown date in 2023; Coronary Artery Bypass Graft x3..