Received May 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK346AA | IM / LL |
received a dose of Pentacel that was unsuitable for use due to an extended temperature excursion with no AE; administration of first dose of the series at 6 months rather than 2 months of age with no AE; Initial information received on 22-Apr-2026 regarding an unsolicited valid non-serious case received from other or unknown healthcare professional. This case involves a 6-month-old male patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] rather than 2 months that was unsuitable for use due to an extended temperature excursion with no adverse event. The patient's past medical history, past drugs, vaccination(s), family history, concomitant medications were not provided. No concomitant vaccines were given. On 13-Apr-2026, the patient at 6 months of age received a dose 1 with dosage 0.5 ml of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO)/HIB(PRP/T) VACCINE powder and suspension for suspension for injection (batch: UK346AA, expiry: unknown) (strength: unknown) via intramuscular route in an left thigh for immunization rather than 2 months that was unsuitable for use due to an extended temperature excursion with no adverse event (Poor quality product administered) (Off label use) (Latency: same day). It was reported, "Reason for excursion was Technical failure of equipment, Max temperature reached was 15 degrees Celsius from 08 April 2026 to 21 April 2026 (13 days), No Previous Excursion, No Human error and extended stability data does not cover the excursion. The product administered to a patient after excursion." 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.