Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK379AA | IM / LL |
pentacel was administered without the hib component with no reported adverse event; Initial information received on 24-Apr-2026 regarding an unsolicited valid non-serious case received from a health care professional (HCP). This case involves a 4-month-old male patient who was administered to Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine without the hib component with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, concomitant medications were not provided. Concomitant medication(s) included pneumococcal vaccine conj 20v (cRM197) (Prevnar20) and rotavirus vaccine (Rotavirus vaccine). On 24-Apr-2026, the patient received a 0.5 mL intramuscular dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection (batch/lot number: UK379AA, expiration date: 31-Mar-2027) (strength: unknown) via intramuscular route in left thigh for immunization [Immunisation]. The patient experienced pentacel was administered without the hib component with no reported adverse event (Single component of a two-component product administered, onset date: 24-Apr-2026 and latency: same day). Action taken: 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.
Comments: NONE
Prevnar 20; Rotavirus vaccine