Received Apr 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
palsy-like" reaction at 6 months of age after receiving ACTHIB and VAXELIS; Initial information received on 08-Apr-2025 regarding an unsolicited valid serious case received from a other health professional. This case involves a 6 months old female patient who had palsy-like" reaction at 6 months of age 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. On 22-Jul-2024, the patient received a 0.5ml dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection standard strength, frequency-once, (lot number, expiry date-unknown) via unknown route in unknown administration site for Immunization. On an unknown date the patient developed a serious palsy-like" reaction at 6 months of age after receiving acthib and vaxelis (paralysis) (latency-6 months). Reportedly- The patient continues to see a neurologist since the adverse reaction. Caller didn't have any further information about current symptoms/treatment other than the patient sees a neurologist for ongoing problems. The patient received the products at another pediatrician's office, so the details of administration are limited. 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- This event is assessed as medically significant.; Sender's Comments: Sanofi company comment dated 11-Apr-2025: This case involves a 6 months old female patient who had palsy-like" reaction at 6 months of age after receiving HIB (PRP/T) vaccine [ACT-HIB].Further information regarding regarding allergic history, medical history, concomitant medication and tolerance, 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 suspect vaccine cannot be assessed.