Received Sep 12, 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 |
Acute Kidney Injury; Diabetic Ketoacidosis; Worsening Atrial Flutter; Worsening Atrial Flutter; This 61-year-old male subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 12-SEP-2022, for prophylaxis. Concurrent medical conditions included atrial flutter, hypertension and type ii diabetes mellitus. On 29-NOV-2022, 78 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 acute kidney injury (Verbatim: Acute Kidney Injury). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 diabetic ketoacidosis (Verbatim: Diabetic Ketoacidosis) on 29-NOV-2022 with serious criteria of hospitalization, moderate - grade 2 atrial flutter (Verbatim: Worsening Atrial Flutter) on 29-NOV-2022 with serious criteria of hospitalization and moderate - grade 2 condition aggravated (Verbatim: Worsening Atrial Flutter) on 29-NOV-2022 with serious criteria of hospitalization. The subject was treated with sodium chloride and insulin nos (Insulin, Regular). The action taken with RSVPreF3 vs Placebo was no change. The outcome of acute kidney injury was resolved on 03-DEC-2022. The outcome(s) of the additional event(s) included diabetic ketoacidosis (resolved on 03-DEC-2022), atrial flutter (not resolved) and condition aggravated (not resolved). Diagnostic results (reference ranges are provided in parenthesis if available): Blood creatinine- 29-NOV-2022 2.43 mg/dL, (0.70-1.20). Blood glucose- 29-NOV-2022 640 mg/dL, (70.00-90.00). Cardiac telemetry-In NOV-2022 atrial flutter/atrial fibrillation at 2.91 %. Heart rate-In NOV-2022 135 - 178 with maximum interval of 18 hours bpm. The investigator considered that there was no reasonable possibility that the acute kidney injury, diabetic ketoacidosis, atrial flutter and condition aggravated may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the acute kidney injury, diabetic ketoacidosis, atrial flutter and condition aggravated may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2023113435, US2023115567 GSK receipt date: 24-AUG-2023. Subject is a 61 year old male with a history of diabetes mellitus type 2 and hypertension who presented to the office for visit 5 on 21AUG2023. At that time, he informed the site that he has been treated for atrial fibrillation since spring of 2022. On review of requested medical records, he was diagnosed with atrial flutter by a cardiac electrophysiologist. No treatment started secondary to arrhythmia spontaneously converted. On 29NOV2022, subject presented to hospital with palpitations, light headedness, and chest pain. He was admitted to the hospital with worsening atrial flutter, diabetic ketoacidosis, and acute kidney injury. Mobile cardiac telemetry revealed atrial flutter/atrial fibrillation at 2.91% with a heart rate range of 135 - 178 bpm with maximum interval of 18 hours. Electrophysiologist diagnosed/interpreted these results as atrial flutter and Subject underwent intracardiac radio-frequency ablation on 02DEC2022. He was treated with IV fluids and insulin for the diabetic ketoacidosis. Glucose was corrected and the diabetic ketoacidosis was resolved. He was also treated with IV fluids for his acute kidney injury with resolution. Subject discharged in stable condition 03DEC2022. This episode of atrial flutter was resolved 02DEC2022. However, this was a chronic condition, so this is not recovered/ not resolved at end of study. Follow up information received on 31-Aug-2023. Summary of changes: Lab data and narrative updated. Follow up information received on 05-SEP-2023. Summary of changes: medical history updated. Follow up information received on 26-SEP-2023. Summary of changes: Treatment medication 0.9 % sodium chloride and Insulin regular added. Follow up information received on 25-JUN-2024. Summary of changes: General narrative updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of Acute kidney injury, Diabetic ketoacidosis, Atrial flutter and Condition aggravated ,456 days after receiving 2nd dose of RSVPreF3 ,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, alternative risk factor (diabetes mellitus type 2) based on medical history for the event Diabetic ketoacidosis and alternate etiology (previous known atrial flutter) based on medical history for Atrial flutter event. US-GSK-US2023113435: US-GSK-US2023115567:
Atrial flutter; Hypertension; Type II diabetes mellitus
Test Date: 20221129; Test Name: Creatinine; Test Result: 2.43 mg/dl; Test Date: 20221129; Test Name: Blood glucose; Test Result: 640 mg/dl; Test Date: 202211; Test Name: Mobile cardiac telemetry; Result Unstructured Data: (Test Result:atrial flutter/atrial fibrillation at 2.91 %,Unit:unknown,Normal Low:,Normal High:); Test Date: 202211; Test Name: heart rate; Result Unstructured Data: (Test Result:135 - 178 with maximum interval of 18 hours,Unit:bpm,Normal Low:,Normal High:)