Received Apr 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK307AA | — |
only the first component of PENTACEL was administered and not the second/ Only the liquid was given, patient did not receive the powder, with no reported adverse event; Initial information received on 02-Apr-2026 regarding an unsolicited valid non-serious case received from a nurse practitioner. This case involves a 4 months old male patient who had administered only the first component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL] was administered and not the second/only the liquid was given, patient did not receive the powder, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. Concomitant medication(s) included Hepatitis B vaccine and PCV 20. On 06-Mar-2026, the patient received a 0.5 mL 1X dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE powder and suspension for suspension for injection (batch: UK307AA, expiry: 31-Aug-2026) (strength: unknown) via unknown route in an unknown administration site for immunization and discovered that only the first component of PENTACEL was administered and not the second with no reporter adverse event (Single component of a two-component product administered, onset: 06-Mar-2026, 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
Hep; Pneumococcal vaccine