Symptomtext
Now they have come to realize that one of those children received the diluent only rather than the actual vaccine. They are not sure which of the children received the diluent only with no reported adverse event; Initial information received on 15-Dec-2023 from country regarding an unsolicited valid non-serious case received from other health professional. This case involves a Child and unknown gender patient who received the diluent only rather than the actual vaccine, they are not sure which of the children received the diluent only with no reported adverse event after receiving HIB (PRP/T) vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Dec-2023, the patient received 0.5 mL dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (Frequency: once; Strength: standard) (lot number: UJ835AB; expiry date: unknown) via intramuscular route in unknown administration site for Immunization; patient received the diluent only (diluent is 0.4% saline) rather than the actual vaccine, they are not sure which of the children received the diluent only with no reported adverse event (product preparation error) (same day latency). Treatment- vaccines will be repeated 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 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.