Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | UNK | IM / LA |
New onset Atrial Fibrillation; This 78-year-old female subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, left deltoid) .5 ml on 15-AUG-2024, for prophylaxis. Previously administered products included Influenza vaccine (The subject was received Influenza Vaccine on 25-OCT-2023 via Intramuscular for prophylaxis). Concomitant products included metformin, glimepiride, lisinopril, furosemide, colecalciferol (Vitamin D3), salbutamol sulfate (Ventolin Hfa), biotin, paracetamol (Acetaminophen) and pioglitazone. On 23-JAN-2025, 161 days after receiving RSVPreF3 vaccine + AS01E, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: New onset Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with apixaban (Eliquis). The outcome of atrial fibrillation was resolved on 24-JAN-2025. Diagnostic results (reference ranges are provided in parenthesis if available): Cardiac stress test-In JAN-2025 normal. Chest X-ray-In JAN-2025 no acute lung findings. Echocardiogram-In JAN-2025 normal. Electrocardiogram-In JAN-2025 showing AFib, age heart rate score 5. Heart rate-In JAN-2025 anywhere from low 100s to 130s. 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. GSK Receipt Date: 19-FEB-2025 Subject presented to the hospital with new onset AFib (Atrial fibrilation). Did not had any chest pain or palpitations but did had frequent belching and dyspepsia. Cardiac monitor noted that heart rate was anywhere from low 100s to 130s.Subject given one dose of Cardizem which improved heart rate. Subject still bradycardic upon discharge so placed on Eliquis. ECHO (Echocardiogram) and stress test normal and cleared by cardiology and hospital for discharge. AE (adverse event) was not related to study treatment. Hospital Admission date was 23-Jan-2025 Hospital Discharge date was 24-Jan-2025 SAE (serious adverse event) was not Related to Study Participation Activities other than Study Treatment. Date event became serious: 23-Jan-2025 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow-up information received on 26-MAR-2025 Summary of changes: Treatment medication Eliquis was updated, Lab data was updated and General narrative comment was updated.; Sender's Comments: A case of Atrial fibrillation, 161 days after receiving 1st dose of RSVPreF3 vaccine + AS01E in a 78-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factors (Age, concomitant lisinopril and furosemide).
METFORMIN; GLIMEPIRIDE; LISINOPRIL; FUROSEMIDE; VITAMIN D3; VENTOLIN HFA; BIOTIN; ACETAMINOPHEN; PIOGLITAZONE
Test Date: 202501; Test Name: stress test; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Date: 202501; Test Name: X-ray of the chest; Result Unstructured Data: (Test Result:no acute lung findings,Unit:unknown,Normal Low:,Normal High:); Test Date: 202501; Test Name: ECHO; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Date: 202501; Test Name: EKG; Result Unstructured Data: (Test Result:showing AFib, age heart rate score 5,Unit:unknown,Normal Low:,Normal High:); Test Date: 202501; Test Name: heart rate; Result Unstructured Data: (Test Result:anywhere from low 100s to 130s,Unit:unknown,Normal Low:,Normal High:)