Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 2 | C5190AA | OT / LL |
epilepsy; Initial information received on 18-Jul-2025 regarding an unsolicited valid serious case received from a other health professional. This case is linked with the following cases- US-SA-2025SA209950, US-SA-2025SA209738 and US-SA-2025SA209387. This case involves a 3 months old male patient who had epilepsy after receiving Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB vaccine conj (tet tox) (Act hib), Diphtheria Vaccine Toxoid, Hib Vaccine Conj (Tet Tox), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Mrc 5), Tetanus Vaccine Toxoid (Pentacel) and Polio vaccine inact 3v (Vero) (Ipol) for Immunisation. On 18-Sep-2017, the patient received 0.5mL (dose 1) of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot C5190AA) via intramuscular route in the left thigh and on 21-Jun-2021 he also received 0.5mL (dose 2) (lot C5743AA) (strength standard and frequency once) (expiry date unknown) via intramuscular route in the right deltoid for prophylactic vaccination (Immunisation). On an unknown date in Nov-2017, the patient developed epilepsy (epilepsy) (latency approximately two months) following the administration of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine. 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 Unknown for the event. Seriousness criteria - The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 22-JUL-2025: This case involves a 3 months old male patient who had epilepsy after receiving Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel]. Further information regarding allergic history, laboratory investigations, medical history and tolerance, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. US-SA-2025SA209387:pentacel US-SA-2025SA209950:IPOL
PENTACEL; Act hib; Ipol