Received Apr 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK370AA | IM / RL |
Only the ACTHIB portion of PENTACEL had been administered and it was reconstituted with an incorrect diluent with no reported adverse event; Initial information received on 30-Mar-2026 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 4 months old female patient who received only the ActHIB portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV (VERO)/HIB(PRP/T) vaccine [Pentacel] had been administered and it was reconstituted with an incorrect diluent 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 PCV 20 and ROTAVIRUS. On 27-Mar-2026, the patient received a 0.5 mL once dose 2 of diphtheria/tetanus/5 hybrid AC pertussis/IPV (VERO)/HIB(PRP/T) vaccine powder and suspension for suspension for injection (batch: UK370AA, expiry: 31-Mar-2027) (strength: standard) via intramuscular route in right vastus lateralis for immunization and only received the ActHIB portion of PENTACEL and it was reconstituted with an incorrect diluent (single component of a two-component product administered) (latency: same day). The patient only received the ACTHIB portion, which was reconstituted with sterile water from Merck. The patient did not receive the DTAP IPV liquid portion of the vaccine. 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.
Prevenar 20; Rotavirus vaccine