Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | — | IM |
New onset of atrial fibrillation; This 64-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 21-JUL-2021, for prophylaxis. Concurrent medical conditions included hyperlipidemia, diabetes mellitus, coronary artery disease and hypertension. Concomitant products included amlodipine besilate (Norvasc), atorvastatin calcium (Lipitor) and aspirin. On 13-AUG-2021, 23 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 atrial fibrillation (Verbatim: New onset of atrial fibrillation). Serious criteria included hospitalization. The subject was treated with heparin, diltiazem (Cardizem), metoprolol succinate, apixaban (Eliquis) and amiodarone hydrochloride (Pacerone). The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial fibrillation was resolved on 15-AUG-2021. Relevant Tests: On 13-Aug-20221 ECG showed atrial fibrillation 13AUG2021 echocardiogram showed significant finding.. 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. Linked case(s) involving the same subject: US2021175285, US2021175286 Subject presented to site for Visit 2. Reported that he was in the hospital due to waking up with chest pain and very sweaty. Went to ER on Friday 13 Aug 2021 via ambulance and after several tests and blood work Atrial Fibrillation was diagnosed. Admitted until 15AUG 2021, upon discharge stated felt much better an went home with increased Metoprolol, new RX Amiodarone, new RX of Eliquis. Medications prior to hospitalization aspirin, amlodipine, diuretics, atorvastatin Hospital records obtained and reviewed with subject. PI performed a physical exam and deemed no relationship to the vaccine. Follow-up information received on 03-MAY-2023. Summary of changes: action taken updated. Follow-up information received on 10-MAY-2023. Summary of changes: Narrative updated. Follow-up information received on 19-Sep-2023. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Summary of changes: Lab data, AESI sentence and treatment medication added. Follow up information received on 07-Nov-2023. Summary of changes: Concomitant products added. Narrative updated. Follow up information received on 28-MAY-2024 Summary of changes: Treatment medication metoprolol succinate ER (Toprol-xl), amiodarone (pacerone) Continuing at the end of the study updated as Yes, Treatment medication apixaban (eliquis) End date updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of atrial fibrillation, 23 days after receiving 1st dose of RSVPreF3 vaccine, in a 64-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering alternative etiology (hyperlipidemia, diabetes mellitus, coronary artery disease and hypertension) as risk factors based on medical history. US-GLAXOSMITHKLINE-US2021175285: US-GLAXOSMITHKLINE-US2021175286:
Coronary artery disease; Diabetes mellitus; Hyperlipidemia; Hypertension
NORVASC; LIPITOR; ASPIRIN
Comments: On 13-Aug-20221 ECG showed atrial fibrillation 13AUG2021 echocardiogram showed significant finding.