Received Aug 4, 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: Cochlear implant status, with no reported adverse event; Initial information received on 30-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 78 years old male patient who had an intentional off label prescription by HCP (healthcare professional): diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was prescribed with off label diagnosis: cochlear implant 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 had an intentional off label prescription by HCP: diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection at a dose of 0.5 ml with frequency- 4 times (strength, expiry date and lot not reported) via intramuscular route in unknown administration site was prescribed with off label diagnosis: cochlear implant (Cochlea implant) status, with no reported adverse event (off label use) (same day latency). Information on the batch number could not be requested corresponding to the one at time of event occurrence. Action taken was not applicable.