Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK233AA | IM / LL |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK233AA | OT / LL |
used sterile water as a diluent instead of the actual diluent; soreness and stiffness in the leg; soreness and stiffness in the leg; diaper rash prior to the administration of the vaccine but the father reported that it worsened after the injection; rash in the genitals; 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 is linked to (US-SA-2025SA311990). This case involves a 21 months old male patient who was administered HIB (PRP/T) vaccine [ACT-HIB] and used sterile water as a diluent instead of the actual diluent and experienced rash in the genitals, soreness and stiffness in the leg, diaper rash prior to the administration of the vaccine but the father reported that it worsened after the injection, rash and redness around the injection site. The patient's past vaccination(s) included Pentacel for the last 3 visits with the last dose given on 30Jul2024. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Dermatitis diaper. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap); Influenza vaccine (Flu); and pneumococcal vaccine CONJ 20V (CRM197) (Pneumococcal Vaccine CONJ 20V (CRM197)) all for Immunisation. On 14-Oct-2025, the patient received a dose 4 of 0.5 ml once of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot UK233AA; expiry date: 30-Jun-2026; strength: standard) via intramuscular route in the left thigh for Immunization and used sterile water as a diluent instead of the actual diluent (product preparation error) (latency: same day). On an unknown date in Oct-2025 the patient had rash in the genitals (genital rash); soreness and stiffness in the leg (musculoskeletal stiffness) (pain in extremity); 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 (vaccination site rash) (vaccination site erythema) (unknown latency). It was reported, "Immunization/Vaccine coordinator added that they are unsure if the rash in the genitals was related to the injection or the diaper rash." Action taken was not applicable. No corrective treatment was received for the events (soreness and stiffness in the leg, rash and redness around the injection site, rash in the genitals, diaper rash prior to the administration of the vaccine but the father reported that it worsened after the injection). At time of reporting, the outcome was Unknown for the events (soreness and stiffness in the leg, rash and redness around the injection site, rash in the genitals, diaper rash prior to the administration of the vaccine but the father reported that it worsened after the injection). 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.; Sender's Comments: US-SA-2025SA311990:02693277 (twin patient)
Diaper rash
Dtap; Flu; PNEUMOCOCCAL VACCINE CONJ 20V (CRM197)