Received May 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK381AB | IM / LA |
ACTHIB was diluted with sterile water (not the ACTHIB diluent) and administered to a patient, with no reported adverse event; Initial information received on 05-May-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP) other. This case involves a 15-month-old female patient and is reported HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] was diluted with sterile water (not the ACTHIB diluent) and administered to a patient, with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history were not provided. Concomitant medication(s) included [Pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20)]. On 04-May-2026, the patient received a 0.5 mL dose 4 once dose of HIB (PRP/T) VACCINE [ACT-HIB] (batch: UK381AB, expiry: 31-Mar-2027) strength: standard via intramuscular route in left arm for Immunization which was diluted with sterile water (not the ACTHIB diluent) and administered to a patient, with no reported adverse event [(Product preparation issue, onset: 04-May-2026 and 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
Prevnar 20