Received Mar 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK345AB | IM / LL |
received the PENTACEL vaccine but the liquid portion was a regular sterile diluent and not the liquid that came with the PENTACEL, with no reported adverse event; Initial information received on 11-Mar-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP) other. This case involves a 4-month-old female patient who received the suspect diphtheria/tetanus/2 AC pertussis/IPV (VERO)/HIB (PRP/T) vaccine, but the liquid portion was a regular sterile diluent and not the liquid that came PENTACEL 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 rotavirus vaccine live reassort oral 5v and pneumococcal conjugate vaccine. On 10-Mar-2026, the patient received 0.5 ml (dose 2) of suspect diphtheria/tetanus/2 AC pertussis/IPV (VERO)/HIB (PRP/T) vaccine Powder and suspension for suspension for injection (Strength = standard) frequency: once via intramuscular in Left Vastus Lateralis for immunization but the liquid portion was a regular sterile diluent and not the liquid that came with the PENTACEL (Product preparation error) (onset: 10-Mar-2026 and latency: same day) (batch: UK345AB, expiry: 31-Jan-2027). Action taken: not applicable Event outcome: Unknown for product preparation error. 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
Rotateq; Pneumococcal conjugate vaccine