Received Apr 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK333AA | IM / RL |
powder component of PENTACEL was reconstituted with sterile water, with no reported adverse event; Initial information received on 01-Apr-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 9 months old male patient who was administered with powder component of diphtheria/tetanus/5 hybrid AC pertussis/IPV (VERO)/HIB(PRP/T) vaccine (PENTACEL) was reconstituted with sterile water, 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 Prevnar. On 26-Mar-2026, the patient received a 0.5 mL once dose 1 of diphtheria/tetanus/5 hybrid AC pertussis/IPV (VERO)/HIB(PRP/T) vaccine powder and suspension for suspension for injection (batch: UK333AA, expiry: 30-Sep-2026) (strength: unknown) via intramuscular route in an right thigh for immunization and powder component of Pentacel was reconstituted with sterile water, with no reported adverse event (Single component of a two-component product administered) (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.
Prevnar