Received Jul 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
Intentional Off Label Prescription by HCP: Pentacel is prescribed with off label diagnosis Stem cells transplant status with no reported adverse event; Initial information received on 08-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 65 years old male patient who had prescription by hcp (healthcare professional) intentional off label: Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] is prescribed with off label diagnosis stem cells transplant status with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5mL of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (frequency 4 times) (lot number, expiry date and strength not reported) via intramuscular route in unknown administration site and intentional off label prescription by hcp: pentacel is prescribed with off label diagnosis stem cells transplant status with no reported adverse event (off label use). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. No follow up possible since reporter denied to respond to Sanofi PV Follow up.