Symptomtext
YF-VAX was administered today and inadvertently reconstituted with sterile water instead of the provided sodium chloride with no reported adverse event; Initial information received on 20-Nov-2023 regarding an unsolicited valid non-serious case received from a nurse. This case involves 1 years old female patient who was administered yellow fever vaccine - [YF-VAX] today and inadvertently reconstituted with sterile water instead of the provided sodium chloride 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 measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination (Immunization). On 20-Nov-2023, the patient was administered a standard dose of suspect yellow fever vaccine - Solution for injection at a dose of 0.5 ml total (lot UJ951AA, expiry date- 30-NOV-2024) via subcutaneous route in unknown administration site for Immunization and inadvertently reconstituted with sterile water instead of the provided sodium chloride with no reported adverse event (product preparation error) latency- same day). Reportedly, Caller reporting the dose was given using the diluent for a dose of MMR. Caller declined to provide patient data until discussed with parent. Caller with question on if dose needs repeating in what time frame can it be administered. 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.