Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK346AA | IM / LL |
due to administration of PENTACEL after reconstitution with a different diluent with no reporter adverse event; Initial information received on 28-Apr-2026 regarding an unsolicited valid non-serious case received from an other health care professional (HCP). This case involves a 5-month-old male patient who was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (PENTACEL) after reconstitution with a different diluent with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. Concomitant medication(s) included pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) and rotavirus vaccine live reassort oral 5v (rotateq). On 20-Apr-2026, the patient received 0.5 ml (dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (PENTACEL) powder and suspension for suspension for injection, Strength = standard, frequency: once via intramuscular route in the left thigh for immunization after reconstitution with a different diluent with no reported adverse event (Product preparation issue and latency: same day) (batch: UK346AA, expiry date: 31-Jan-2027). It was reported "A vaccine coordinator stated that a medical assistant gave a patient the Hib portion of PENTACEL with a diluent meant for live vaccines of Merck. The healthcare professional (HCP) administered the Hib portion of PENTACEL to the patient using a diluent made for Merck's live vaccine. The caller sought guidance regarding PENTACEL and wanted to know if there were any adverse events they should look out for, and asked what guidelines they would need to follow". 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.
Comments: NONE
Prevnar 20; Rotateq