Received Feb 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK149AB | OT / RL |
diagnosed with infantile spasm; Initial information received on 04-Feb-2025 regarding an unsolicited valid serious case received from a other health professional. This case involves a 5 months old female patient who was diagnosed with infantile spasm after receiving Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)]. The patient's past vaccination(s) included HEPATITIS B VACCINE on 03-JAN-2025. The patient's past medical history, medical treatment(s) ,concomitant medications and family history were not provided. On 21-Jan-2025, the patient received a dose of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) lot UK149AB, Expiry date; 31-Aug-2025, strength was unknown via intramuscular route in the right thigh for Immunization. On 28-JAN-2025 the patient diagnosed with infantile spasm (infantile spasms) (latency: 7 days) following the administration of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (diagnosed with infantile spasm). At time of reporting, the outcome was Unknown for the event diagnosed with infantile spasm. Seriousness Criteria : This event was assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 07-Feb-2025 : This case involves a 5 months old female patient who was diagnosed with infantile spasm after receiving Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)].Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.