Report #2840381

Overview

Sex

Female

Age

2 yrs

State

ME

Recovered

Unknown

Vaccinated

Apr 22, 2025

Onset

Apr 22, 2025

Days to onset

0

Hospital days

—

Symptoms (2)

Symptom narrative

2-year-old QUADRACEL with DAPTACEL, so patient received two DTap with no reported adverse event; Initial information received on 22-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 years old female patient who had received Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine [Quadracel (Vero)] And Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel], so the patient received two dtap with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Apr-2025, the patient received doses with dosage 0.5 ml of suspects Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine Suspension for injection (lot U8009AB, Expiry: 31-Jan-2026) and Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot 3CA11C1, Expiry: 31-DEC-2025) (Strength: Standard) via unknown route in unknown administration site as immunization, so patient received two dtap with no reported adverse event (extra dose administered) (Latency: same day). Reportedly, Reporter is calling to make there is no reaction or anything. Action taken: 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.; Sender's Comments: US-SA-2025SA119219: