Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | IM |
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | — | IM |
Atrial Flutter; 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 26-SEP-2022, for prophylaxis. Concurrent medical conditions included atrial fibrillation (A-Fib). Concomitant products included apixaban (Eliquis). On 30-DEC-2022, 95 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 atrial flutter (Verbatim: Atrial Flutter). Serious criteria included hospitalization. The subject was treated with diltiazem, acetylsalicylic acid (Aspirin), paracetamol (Acetaminophen), sodium chloride and heparin. The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial flutter was resolved on 04-JAN-2023. Relevant Tests: On 31DEC2022 Echocardiogram showed Normal On unknown Dec 2022 normal chest x-rays we do not have the ECG tracings but have the readings of A. Flutter with RVR On 04JAN2023 Echo Transesophageal No evidence of intracardiac thrombus. Diagnostic results (reference ranges are provided in parenthesis if available): Troponin-In DEC-2022 elevated. The investigator considered that there was no reasonable possibility that the atrial flutter may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial flutter may have been caused by RSVPreF3 vs Placebo. GSK Receipt date: 17-JAN-2023 Subject was hospitalized from 31DEC2022 until 04JAN2023 for atrial fibrillation. On 04JAN2023 had cardioversion on 04JAN2023 and was given Eliquis started taking on 04JAN2023 and continues. 17JAN2023 +/+ subj stated 31DEC2022 (to) 04JAN2023 'heart flutter' (atrial fib) Eliquis 04JAN2023 'shock heart in place' Clarification 'cardioversion' Subj went to PCP on 16JAN2023 for follow up and stated 'all clear.' Also asked subject about releasing medical records; subj stated he was not sure he should allow this since he told me all the information needed for his condition. 23FEB2023 medical release signed Per PI, further discussion of Adverse Event of Special Interest. Clinical considerations, - subject has AFIB since 1990, no known history of hyperthyroidism or amyloidosis or other predisposing pathologies for Fib/flutter. He was admitted for A flutter on 31DEC2022. Concurrent medical conditions nonsignificant for atrial flutter/fibrillation genesis of continuation. He does have thrombocytopenia. Subject had successful cardioversion on 04JAN2023. He also had presumptive diagnosis of NSTEMI treated with Cardizem IV, anticoagulation was begun, we do not have the ECG tracings but have the readings of A. Flutter with RVR. Per medical records troponin assessed approx 30Dec2022. Follow-up information received on 18-JAN-2023 Summary of change: Eliquis was updated to treatment medication from concomitant medication. Follow-up information received on 23-JAN-2023 Summary of change: Lab data removed (Atrial Fibrillation) Follow-up information received on 25-Jan-2023 Summary of change: Concomitant medication was updated to treatment medication and investigator text was updated. Follow-up information received on 27-APR-2023 Summary of changes: Action taken updated. Follow-up information received on 09-MAY-2023 Summary of changes: Narrative updated. Follow-up information received on 01-Jun-2023. Summary of changes: Narrative updated, event updated from Atrial Fibrillation to Atrial Flutter. Follow-up information received on 05-JUN-2023. Summary of changes: Relevant medical condition updated. Follow-up information received on 14-JUN-2023. This case contains an event assessed by the investigator as a adverse event of special interest (AESI). Summary of changes: Narrative updated Follow-up information received on 22-JUN-2023. The subject received concomitant medication Heparin from 31/Dec/2022 to 14/Jan/2023, 12.0 unknown at Continuous infusion for the Indication of Stroke Prophylaxis Intravenously. Summary of changes: Concomitant medication and lab data added. Follow-up information received on 11-JUL-2023 Summary of changes: Narrative updated. Follow-up information received on 17-JUL-2023 Summary of changes: Lab test updated. Follow-up information received on 29-AUG-2023 Summary of changes: Narrative updated. Follow-up information received on 25-OCT-2023 Summary of changes: Narrative updated. Follow-up information received on 03-JUN-2024 Summary of changes: concomitant drugs updated to treatment drugs. Follow up information received on 04-JUL-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial flutter, 527 days after receiving 2nd dose of RSVPreF3 vaccine + AS01E 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 and alternative risk factor (h/o atrial fibrillation).
Atrial fibrillation (A-Fib)
ELIQUIS
Test Date: 202212; Test Name: troponin; Result Unstructured Data: (Test Result:elevated,Unit:unknown,Normal Low:,Normal High:); Comments: On 31DEC2022 Echocardiogram showed Normal On unknown Dec 2022 normal chest x-rays we do not have the ECG tracings but have the readings of A. Flutter with RVR On 04JAN2023 Echo Transesophageal No evidence of intracardiac thrombus