Received Apr 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK235AC | IM / LL |
administering pentacel with only the lyophilized component and reconstituting with the wrong diluent, was reconstituted wit sterile water with no reported adverse event; Initial information received on 27-Mar-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 year old male patient who was administered with suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine-[PENTACEL] only the lyophilized component and reconstituting with the wrong diluent, was reconstituted with sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history, concomitant medications were not provided. Concomitant medication(s) included varicella zoster vaccine live, measles vaccine live, mumps vaccine live, rubella vaccine live and hepatitis a vaccine inact. On 26-Mar-2026, the patient received 0.5ml Dose of Suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine powder and suspension for suspension for injection, frequency: once, batch: UK235AC, expiry: 31-Aug-2026, Strength = lyophilized component was reconstituted with sterile water, via intramuscular route in the left thigh for immunization, only the lyophilized component and reconstituting with the wrong diluent, 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.
Comments: NONE
Varivax; Mmr ii; Havrix