Received Aug 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 3 | — | OT |
received PENTACEL at 3 months, 5 months and 6 months. Patient's mother was concerned about the patient's 3rd dose because it only has a 1 month interval from the second dose with no reported adverse event; Initial information received on 21-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 7 months old female patient who received 3 doses of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel] at 3 months, 5 months and 6 months, patient's mother was concerned about the patient's 3rd dose because it only has a 1 month interval from the second dose 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 3 doses of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization at 3 months, 5 months and 6 months, patient's mother was concerned about the patient's 3rd dose because it only has a 1 month interval from the second dose with no reported adverse event (inappropriate schedule of product administration) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.