Report #2853857

Overview

Sex

Female

Age

12 yrs

State

NY

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

patient received a Tdap dose after DTaP earlier than the recommendation from the prescribing information with no reported adverse event; Initial information received on 07-Aug-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 12 years old female patient who received a Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] dose after dtap earlier than the recommendation from the prescribing information 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 an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunisation and a tdap dose received after dtap earlier than the recommendation from the prescribing information with no reported adverse event (incorrect dose administered) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, se received Dtap at 4 yrs 7mos, and then Tdap at 7yrs 10 mos, then she received her 3rd dose of Tdap when she was almost 8 yrs old. Caller stated that she was now 12 yrs old and has an appointment today to receive the Tdap and she wantwd to know if it would be okay. 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.