Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 3CA55C1 | OT / RL |
2-year-old was administered dose of DAPTACEL which was not due again until 4 years of age with no reported adverse event; Initial information received on 17-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked t oUS-SA-2025SA113271 (cluster case) This case involves a 2 years old female patient who received a dose of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] which was not due again until 4 years of age 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) and Varicella zoster vaccine (Varicella vaccine) both for Immunisation. On an unknown date, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine, Suspension for injection, (unknown strength, expiry date and lot number not reported,) via unknown route in unknown administration site for immunization On 17-Apr-2025, the patient received an extra 0.5ml dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine, Suspension for injection, Strength Standard, frequency once, Expiry date 31-Aug-2026, lot 3CA55C1 via intramuscular route in the right thigh for immunization, which was not due again until 4 years of age with no reported adverse event (Extra dose administered) (Latency Same day). 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.; Sender's Comments: US-SA-2025SA113271:IPOL
Mmr; Varicella vaccine