Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | UNK | IM |
Sinus Pause; atrial fibrillation; This 71-year-old female subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) on 22-MAR-2021, for prophylaxis. Concurrent medical conditions included hypothyroidism, hypertension, left bundle branch block, obesity and knee osteoarthritis (bilateral knees). On 01-JUN-2021, 71 days after receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 sinus pause (Verbatim: Sinus Pause). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 atrial fibrillation (Verbatim: atrial fibrillation) on 01-JUN-2021 with serious criteria of hospitalization. The subject was treated with warfarin. The action taken with RSVPreF3 vaccine + AS01E was no change. The outcome of sinus pause was resolved on 07-JUL-2021 10:47. The outcome(s) of the additional event(s) included atrial fibrillation (resolved on 07-JUL-2021 10:47). Relevant Tests: On 06JUL2021 Left subclavian venogram showed revealing patency and course of venous structure.. Diagnostic results (reference ranges are provided in parenthesis if available): Heart rate-In JUL-2021 124 bpm. The investigator considered that there was no reasonable possibility that the sinus pause and atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the sinus pause and atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. GSK Receipt Date: 30-SEP-2021 Subject was a 71-year-old female with history of left bundle branch block, obesity, hypothyroidism, hypertension, and osteoarthritis. Subject was seen in cardiology outpatient in May for atypical chest pain, and stress test and echocardiogram performed. Echo showed normal EF with normal wall motion but did have septal motion abnormal due to LBBB. Stress test was felt to be low risk. She wore a MCT monitor which showed the subject had atrial fibrillation with a 4 second pause. She was started on warfarin and referred to electrophysiology. Subject proceeded to elective permanent pacemaker implantation and received a dual chamber Medtronic device on 06JUL2021. Subject was admitted for procedure on 06JUL2021 and discharged in stable condition on 07JUL2021. subject enrolled into study on 22MAR2021 and received vaccine on 22MAR2021. This meets an AESI criteria per new protocol. Follow-up information received on 19-JUL-2022. This follow up was considered non-significant. Summary of Changes: Treatment product stop date updated Follow-up information received on 10-JUL-2024 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI) Summary of changes: General narrative comments were updated.; Sender's Comments: A case of Atrial fibrillation and sinus arrest, 71 days after receiving 1st dose of RSVPreF3 vaccine + AS01E in a 71-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factors (hypertension, left bundle branch block and obesity) based on medical history.
Hypertension; Hypothyroidism; Knee osteoarthritis (bilateral knees); Left bundle branch block; Obesity
Test Date: 202107; Test Name: Atrial fibrillation with heart rate; Test Result: 124 bpm; Comments: On 06JUL2021 Left subclavian venogram showed revealing patency and course of venous structure.