Report #2847827

Overview

Sex

Female

Age

Age unknown

State

NY

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

received PENTACEL out of sequence, got it one-month early and now she is due for the 15-month dose with no reported AE; Initial information received on 26-Jun-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves Infant female patient who had received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] out of sequence, got it one-month early and now she is due for the 15-month dose with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection, (lot number, strength and expiry date not reported) frequency: once via unknown route in unknown administration site for immunisation, out of sequence, got it one-month early and now she is due for the 15-month dose with no reported ae (inappropriate schedule of product administration) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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.