Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK233AA | OT / LL |
report that they have administered ACTHIB that was administered with sterile water instead of the diluent it came with to twin patients; mentioned that the parents reported both patients have rash in the genitals; soreness and stiffness in the leg; soreness and stiffness in the leg; also have diaper rash prior to the administration of the vaccine but the father reported that it worsened after the injection; condition aggravated; rash and redness around the injection site; rash and redness around the injection site; Initial information received on 17-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 21 months old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] with sterile water instead of the diluent with no ae (adverse event) and had rash in the genitals, soreness and stiffness in the leg, soreness and stiffness in the leg, also have diaper rash prior to the administration of the vaccine but that it worsened after the injection. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Dtap) For Immunisation; Pneumococcal Vaccine (Pneumococcal Vaccine) For Immunisation; And Influenza Vaccine (Flu [Influenza Vaccine]) for Immunisation. On 14-Oct-2025, the patient received an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UK233AA and expiry date-30-Jun-2026) (strength-unknown) via intramuscular route in the left thigh with sterile water instead of the diluent it came with no ae (adverse event) (product preparation error) (latency-same day). On an unknown date in Oct-2025 the patient developed have rash in the genitals (genital rash), soreness and stiffness in the leg (pain in extremity), soreness and stiffness in the leg (musculoskeletal stiffness), diaper rash prior to the administration of the vaccine but the father reported that it worsened after the injection (dermatitis diaper), rash and redness around the injection site (vaccination site erythema) and condition aggravated (unknown latency). Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events of (genital rash), (pain in extremity), (musculoskeletal stiffness), (dermatitis diaper), (vaccination site erythema) and condition aggravated. At time of reporting, the outcome was Unknown for the events of (genital rash), (pain in extremity), (musculoskeletal stiffness), (dermatitis diaper), (vaccination site erythema) and condition aggravated. 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.
DTAP; PNEUMOCOCCAL VACCINE; FLU [INFLUENZA VACCINE]