Received Dec 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK216AB | OT / RL |
blue top DTAP and IPV components of PENTACEL were given to a patient without the ACT-HIB component with no reported adverse event; Initial information received on 04-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 months and 16 days old male patient who received blue top dtap and ipv components of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] without the act-hib component with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) and Rotavirus vaccine live reassort oral 5v (Rotateq) for Immunisation. On 25-Nov-2025, the patient received 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection lot UK216AB, expiry date:31-Jul-2026, Strength :standard, Frequency: once, via intramuscular route in the right thigh for Immunization in which blue top dtap and ipv components of vaccine were given without the act-hib component with no reported adverse event (single component of a two-component product administered) (latency: same day). 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.
Prevnar 20; Rotateq