Received May 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK422AA | IM / LL |
administration of an extra dose/15-month old kid got an additional dose of PENTACEL with no Adverse event; Initial information received on 08-May-2026 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 15-month-old male patient who had administration of an extra dose/ got an additional dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (PENTACEL) with no adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 22-Apr-2026, the patient received a standard dose 4 of 0.5 mL single dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE powder and suspension for suspension for injection (batch number: UK422AA, expiration date: 30-Jun-2027) via intramuscular route in left thigh for immunization. On 04-May-2026, the patient had administration of an extra dose/ got an additional standard dose 5 of 0.5 mL single dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE powder and suspension for suspension for injection (batch number: UK422AA, expiration date: 30-Jun-2027) via intramuscular route in left thigh for immunization, with no adverse event (extra dose administered, latency: same day). As per the clinical manager, it was a mistake on the medical assistant's part and they were just calling to make sure there was not anything specific to do from a medical perspective. The clinic manager also stated that it was supposed to be just DTaP (diphtheria, tetanus, and acellular pertussis) being ordered; however, PENTACEL was given to the patient. 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 medication 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