Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 3CA25C1 | OT / RL |
They gave it to the child 1 week early with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 1 years old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [daptacel] 1 week early 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 VACCIN, hepatitis A vaccine (hepatitis A) for Immunisation and HIB vaccine (HIB vaccine), all for Immunisation. On 25-Feb-2025, the patient received standard dose of 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection once with lot 3CA25C1 and expiry date 30-Apr-2026 via intramuscular route in the right thigh for Immunization 1 week early with no reported adverse event (inappropriate schedule of product administration) (Latency same day). Action taken was not applicable. Reportedly, they gave it to the child 1 week early and she seeking for recommendations and what adverse reaction to watch for. 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.
MMR VACCIN; HEPATITIS A; HIB VACCINE