Received May 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK307AA | OT |
patient had initial dose of pentacel yesterday and ended up in the er overnight with a possible seizure; Initial information received on 06-May-2025 regarding an unsolicited valid serious case received from an other healthcare professional. This case involves a 2 months old and unknown gender patient where patient had initial dose of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] yesterday and ended up in the er (emergency room) overnight with a possible seizure. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-May-2025, the patient received a dose 1 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot UK307AA and expiry date- 31-AUG-2026) via unknown route in unknown administration site (strength: not provided) for Immunization. On 05-MAY-2025 the patient had initial dose of pentacel yesterday and ended up in the er overnight with a possible seizure (seizure) (latency- same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine. This event was assessed as medically significant. Reportedly, No other vaccines were administered at the time. Product used : Used, First time product used : Yes. Action taken- not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Recovering / Resolving for the event.; Sender's Comments: Sanofi Company Comment dated 07-May-2025: This case involves a 2 months old and unknown gender patient where patient had initial dose of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] yesterday and ended up in the er (emergency room) overnight with a possible seizure. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine can be denied.