Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 3 | — | OT |
epilepsy; Initial information received on 18-Jul-2025 regarding an unsolicited valid serious case received from a other health professional. This case linked to US-SA-2025SA209519, US-SA-2025SA209950 and US-SA-2025SA209519 This case involves a 5 months old male patient who had epilepsy after receiving HIB (PRP/T) vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, HIB vaccine conj (tet tox), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Pentacel), Polio vaccine inact 3v (Vero) (Ipol) and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel) all for prophylactic vaccination (Immunisation). On an unknown date in 2017, the patient received an unknown dose (dose 1) of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On an unknown date, the patient received an unknown dose (dose 2) of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On 18-Sep-2018, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot U1915AA, strength: standard and frequency: once) via intramuscular route in the right thigh for prophylactic vaccination (Immunisation). On an unknown date in Nov-2017, the patient developed epilepsy (Latency: few days to few months approxmately) following the administration of (dose 1) of suspect HIB (PRP/T) vaccine [ACT-HIB]. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Not Recovered / Not Resolved for the event. Seriousness criteria: This event was assessed as medically significant; Sender's Comments: Sanofi company comment dated 23-Jul-2025: This case involves a 5 months old male patient who had epilepsy after receiving HIB (PRP/T) vaccine [ACT-HIB]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed US-SA-2025SA209519:pentacel US-SA-2025SA209950:ipol US-SA-2025SA209519:daptacel
Pentacel; Ipol; Daptacel