Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | UNK | — | OT |
reaction to it was kind of like reaction where she had like a type of palsy; Initial information received on 15-Apr-2025 regarding an unsolicited valid serious courtesy case received from a other health professional. This case involves a 15 months old female patient who experienced reaction to it was kind of like reaction where she had like a type of palsy after receiving pneumococcal vaccine CONJ 13V (CRM197) [Prevnar 13], hepatitis B vaccine,HIB (PRP/T) Vaccine [ACT-HIB] and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid [Dtap]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection, an unknown dose hepatitis B vaccine produced by unknown manufacturer via unknown route in unknown administration site, received an unknown dose of Prevnar 13 not produced by Sanofi Pasteur via unknown route in unknown administration site, and received an unknown dose of Dtap not produced by Sanofi Pasteur (formulation not reported) (strength, expiry date and lot number not reported for all) via unknown route in unknown administration site as all for Immunization. On an unknown date the patient developed a reaction to it was kind of like reaction where she had like a type of palsy (paralysis) (unknown latency). Reportedly, the patient was followed by an allergist and this made the allergist think there was an egg or animal component that could had caused the episode. Caller was unable to clarify palsy further to include location on body. 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 was assessed as medically significant. Additional information was received on 06-May-2025 from consumer/non-healthcare professional. Trade name of non-company suspect updated to Prevenar13. Narrative amended accordingly. Additional information was received on 09-Jun-2025 from consumer/non-healthcare professional- Suspect- HIB (PRP/T) Vaccine [ACT-HIB] has been added. Narrative amended accordingly.; Sender's Comments: Sanofi company comment for follow up dated 09-JUN-2025: This case involves a 15 months old female patient who experienced reaction to it was kind of like reaction where she had like a type of palsy after receiving pneumococcal vaccine CONJ 13V (CRM197) [Prevnar 13], hepatitis B vaccine,HIB (PRP/T) Vaccine [ACT-HIB] and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid [Dtap]. Further information regarding concurrent condition during 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 cannot be assessed.