Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | — | IM |
Supraventricular Tachycardia; This 61-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular) on 7th July 2021, for prophylaxis. Concurrent medical conditions included sleep apnea, atrial fibrillation and congestive heart failure. On 12th November 2021, 128 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 supraventricular tachycardia. Serious criteria included hospitalization. The subject was treated with metoprolol, adenosine and sotalol. The outcome of supraventricular tachycardia was recovered/resolved on 18th November 2021. The investigator considered that there was no reasonable possibility that the supraventricular tachycardia may have been caused by RSVPreF3 vs Placebo. Relevant Tests: In Nov-2021, EKG showed ST abnormality, possible inferolateral subendocardial injury, HR 193, Rhythm SVT, Diagnostic results (unless otherwise stated, normal values were not provided): In November 2021, Chest X-ray result was enlarged cardiac silhouette, Electrocardiogram result was see text and Heart rate result was 193. Linked case(s) involving the same subject: US2021199058 INVESTIGATOR TEXT pt went to er on 11/12/2021 with reports of palpitations and heart racing. he was found to be in tachycardia. pt was admitted to the hospital for treatment. Labs and ekg were performed. pt. has a documented medical history of: congestive heart failure, a-fib, allergies, sleep apnea, former smoker, and pt is obese. pt was discharged on 11/18/2021 Follow-up information received on 14-Oct-2022 Summary of changes: Demographic details (height and weight) and Treatment details updated (Treatment sotalol marked as ongoing) Follow up information received on 04-Jul-2024 End of study Unblinding completed. Upon internal review the case was updated on 20-Aug-2024. Correct suspect product added summary of change: Product tab updated.; Sender's Comments: A case of Supraventricular tachycardia, 128 days after receiving 1st dose of RSVPreF3 vs Placebo , in a 61-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 and congestive heart failure). US-GLAXOSMITHKLINE-US2021199058:
Atrial fibrillation; Congestive heart failure; Sleep apnea
Test Date: 202111; Test Name: Chest Xray; Result Unstructured Data: (Test Result:enlarged cardiac silhouette,Unit:unknown,Normal Low:,Normal High:); Test Date: 202111; Test Name: EKG; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Date: 202111; Test Name: HR; Result Unstructured Data: (Test Result:193,Unit:unknown,Normal Low:,Normal High:); Comments: In Nov-2021, EKG showed ST abnormality, possible inferolateral subendocardial injury, HR 193, Rhythm SVT,