Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 3 | C5294AA | OT / LL |
epilepsy after taking pentacel; Initial information received on 18-Jul-2025 regarding an unsolicited valid serious case received from a other health professional. This case is linked to the following cases- US-SA-2025SA209738, US-SA-2025SA209950 and US-SA-2025SA209519. This case involves a 2 months old male patient who had epilepsy after taking Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel); HIB vaccine conj (tet tox) (Act hib) and Polio vaccine inact 3v (Vero) (Ipol) for Immunisation. On 22-Aug-2017 , the patient received 0.5mL (dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot C5370AA) via intramuscular route in the left thigh , on 23-Oct-2017, he also received 0.5mL (dose 2) (lot C5374AA) and on 18-Dec-2017, he also received 0.5mL (dose 3) of vaccine (lot C5294AA) (strength standard and frequency once) (expiry date not reported) via intramuscular route in the left vastus lateralis for Immunisation. On an unknown date in Nov-2017, the patient developed epilepsy after taking pentacel (epilepsy) (latency approximately few few days following the administration of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine. Action taken was not applicable. A corrective treatment was received for the event. At time of reporting, the outcome was Not Recovered / Not Resolved 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 2 months old male patient who had epilepsy after taking Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)]. 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-2025SA209738:Act-hib US-SA-2025SA209950:IPOL US-SA-2025SA209519:Daptacel
Daptacel; Act hib; Ipol