Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | — | IM |
new onset Atrial Fibrillation; This 69-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 12-JUL-2021, for prophylaxis. Concurrent medical conditions included coronary artery disease. On 06-MAR-2022, 237 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: new onset Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with rivaroxaban (Xarelto). The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial fibrillation was not resolved. Relevant Tests: requested records On Unk-Mar-2022 update -chest x-ray showed no evidence of acute cardio pulmonary disease On Unk-Mar-2022 Nuclear stress testing was performed demonstrating " This is a large inferior apical fixed perfusion defect at rest and at stress however with somewhat preserved wall motion suggesting attenuation artifact rather than old inferior MI.... Diagnostic results (reference ranges are provided in parenthesis if available): Ejection fraction-In MAR-2022 50 percent. The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. GSK Receipt Date: 22Mar2022 Subject was a 69 yo male with h/o CAD with HFrEF s/p PPM-ICD who had been experiencing intermittent tiredness, weakness, episodes of SOB for weeks. on 3/6/2022,while on vacation , his device alerted he was in Atrial Fibrillation. His cardiologist started Xarelto and follow up on return home. On 3/15/2022 symptoms worsening and went to ED and was found to be in Atrial Fibrillation. He was admitted to the hospital with successful cardioversion to NSR. TEE performed during hospitalization revealed EF of 50%. Nuclear stress testing was performed demonstrating " Clinical correlation recommended this is a low risk stress test without reversible ischemia. He otherwise had an uneventful hospitalization and was discharge on 3/19/2022 to f/u with cardiologist. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI Follow-up information received on 13-APR-2022. This follow-up was considered significant. Summary of Changes: Investigator text updated Follow-up information received on 26-APR-2022. This follow-up was considered significant. Summary of Changes: added diagnostic test. Follow-up Receipt date: 30-Jun-2022. This follow-up was considered significant. Summary of changes: The Outcome and SAE stop date were updated. Follow up information received on 25-Apr-2023. Summary of changes: Action taken for study vaccine updated. Upon internal review the case was updated on 27-Nov-2023. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Summary of changes: AESI sentence added in narrative. Lab data and general narrative updated. Follow up information received on 29-Nov-2023. Summary of changes: Narrative updated. Follow up information received on 20-DEC-2023 Summary of changes: Relevant medical condition updated, General Narrative comments updated. Follow up information received on 02-MAY-2024 Summary of changes: Event onset date was changed from 07-MAR-2022 to 06-MAR-2022 and event outcome was updated from recovered/resolved to not recovered/not resolved. Follow-up information received on 29-May-2024 Summary of changes: End date was updated for Treatment medication Xarelto as ongoing Follow up information received on 04-Jul-2024 End of study unblinding completed.; Sender's Comments: A case of atrial fibrillation, 237 days after receiving 1st dose of RSVPreF3, in a 69-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative etiology (known history of coronary heart disease with Heart failure with reduced ejection fraction [HFrEF] ) based on medical history.
Coronary artery disease
Test Date: 202203; Test Name: EF; Test Result: 50 %; Comments: requested records On Unk-Mar-2022 update -chest x-ray showed no evidence of acute cardio pulmonary disease On Unk-Mar-2022 Nuclear stress testing was performed demonstrating " This is a large inferior apical fixed perfusion defect at rest and at stress however with somewhat preserved wall motion suggesting attenuation artifact rather than old inferior MI...