Received Jul 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK113AB | OT / LL |
administered ACTHIB with diluent from another vaccine, perhaps sterile water from MMR (with no reported adverse event); administered ACTHIB with diluent from another vaccine, perhaps sterile water from MMR (with no reported adverse event); Initial information received on 16-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 months old female patient who was administered HIB (PRP/T) vaccine [ACT-HIB] with diluent from another vaccine, perhaps sterile water from MMR with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 13-Jun-2025, the patient received an unknown dose of suspect HIB (PRP/T) vaccine with diluent from another vaccine, perhaps sterile water from mmr (formulation: Powder and solvent for solution for injection) (lot UK113AB) (strength and expiry date not reported) via unknown route in the left thigh with no reported adverse event (product preparation error) (poor quality product administered) (Latency: same day) Action taken was 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.
Prevnar 20