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 |
Obstructive nephropathy (left kidney obstruction); Atrial fibrillation with rapid ventricular rate; E. Coli pyelonephritis; left nephrolithiasis; Septic shock; This 74-year-old male subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 28-SEP-2022, for prophylaxis. The subject's past medical history included ex-smoker (former). Concurrent medical conditions included hypertension. On 05-DEC-2022, 68 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 obstructive nephropathy (Verbatim: Obstructive nephropathy (left kidney obstruction)). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 atrial fibrillation with rapid ventricular response (Verbatim: Atrial fibrillation with rapid ventricular rate) on 05-DEC-2022 with serious criteria of hospitalization, severe - grade 3 escherichia pyelonephritis (Verbatim: E. Coli pyelonephritis) on 05-DEC-2022 with serious criteria of hospitalization, severe - grade 3 nephrolithiasis (Verbatim: left nephrolithiasis) on 05-DEC-2022 with serious criteria of hospitalization and severe - grade 3 septic shock (Verbatim: Septic shock) on 05-DEC-2022 with serious criteria of hospitalization. The subject was treated with metoprolol tartrate (Metoprolol Xl), amiodarone and rivaroxaban (Xarelto). The action taken with RSVPreF3 vs Placebo was no change. The outcome of obstructive nephropathy was resolved on 03-FEB-2023. The outcome(s) of the additional event(s) included atrial fibrillation with rapid ventricular response (resolved on 30-DEC-2022), escherichia pyelonephritis (resolved on 30-DEC-2022), septic shock (resolved on 30-DEC-2022) and nephrolithiasis (resolved on 31-JAN-2023). Relevant Tests: On Unknown date in DEC2022,Spinal tap showed infection did not reach brain or spinal fluid. Requested records for more information.. The investigator considered that there was no reasonable possibility that the obstructive nephropathy, atrial fibrillation with rapid ventricular response, escherichia pyelonephritis, nephrolithiasis and septic shock may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the obstructive nephropathy, atrial fibrillation with rapid ventricular response, escherichia pyelonephritis, nephrolithiasis and septic shock may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2023027420 GSK Receipt Date: 05-JAN-2023 Subject went to the hospital for pain. Subject was transferred to a second hospital where he was admitted for sepsis and kidney stones. Subject will follow-up with urologist for kidney stones. Will request medical records for more information. Medical records reviewed. Present to hospital 05Dect2022 with left sided flank pain, nausea, vomiting, diarrhea, and chills. Also, head decreased appetite x2 days. Found to have left sided ureteral stone (8mm) in left distal ureter causing moderate up stream hydroureteronephrosis. Found E. Cli pyelonephritis. Developed septic shock secondary to pyelonephritis (which was due to obstructing renal stone). Required vasopressors and was transferred to tertiary medical center for urological procedure. Underwent left percutaneous nephrostomy tube 06DEC2022. Was treated with ciprofloxacin, later changed to cefazolin, then changed to ceftriaxone for pyelonephritis and septic shock. The hospital course was complicated with atrial fibrillation with RVR, treated with Xarelto, metoprolol and amiodarone. Also subject had delirium/encephalopathy for which he underwent a lumbar puncture and was placed on Seroquel. Was discharged in stable condition home 20DEC2022. Unclear if subject had pneumonia. Will request further records. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow-up information received on 06-JAN-2023 Summary of changes: Event term updated (Septic shock, Obstructing left nephrolithiasis, E. Coli pyelonephritis and Atrial fibrillation with rapid ventricular rate, concomitant medication (Xarelto, Amiodarone and metoprolol XL) and investigator text were updated. Follow-up information received on 10-Jan-2023. Summary of Changes: SAE term splited to Left kidney obstruction and left nephrolithiasis. Follow-up information received on 13-Jan-2023. Summary of Changes: Event start date updated and TTO updated. Concomitant updated as treatment medication. Event term updated. Follow-up information received on 02-MAR-2023. Summary of Changes: SAE outcome for Obstructive nephropathy (left kidney obstruction) was updated Follow-up information received on 17-MAR-2023. Summary of Changes: Xarelto end date updated Follow-up information received on 25-APR-2023 and 27-APR-2023 Summary of Changes: Action taken and outcome of event for left nephrolithiasis updated Follow-up information received on 31-Oct-2023. Summary of Changes: Medical history former smoker and hypertension added. Upon internal review the case was updated on: 04-Dec-2023. Summary of changes: AESI statement added. Follow-up information received on 28-MAY-2024 Summary of changes: End date was updated for Treatment medication Amiodarone and ongoing was updated for treatment medication Metoprolol xl. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of obstructive nephropathy , nephrolithiasis, atrial fibrillation, escherichia pyelonephritis and septic shock, 459 days after receiving 1st dose of RSVPreF3, in a 74-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, and alternative etiology nephrolithiasis for the event obstructive nephropathy and hypertension for atrial fibrillation. US-GSK-US2023027420:
Hypertension
Medical History/Concurrent Conditions: Ex-smoker (former)
Comments: On Unknown date in DEC2022,Spinal tap showed infection did not reach brain or spinal fluid. Requested records for more information.