Received Feb 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 2 | 3CA25C1 | OT / RL |
patient received DAPTACEL two days in a row with no reported adverse event; Initial information received on 31-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 27 months old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] two days in a row with no reported adverse. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB vaccine; Hepatitis a vaccine; Pneumococcal vaccine conj 7v (CRM197) (Prevnar) and Fluvacil for Immunisation. On 30-Jan-2025, the patient received 0.5 ml (dose 2) of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) ( lot 3CA25C1 and expiry date: 30-Apr-2026) via unknown route in the right thigh and on 31-Jan-2025 he again received 0.5 ml (dose 3 ) of the same vaccine, two days in a row, with an unknown batch number and expiry date (strength: standard, frequency twice) via unknown route in the left vastus lateralis for Immunization (extra dose administered) (latency: same day). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested Action taken was not applicable. Reportedly, Pediatric charge nurse reported that a patient received DAPTACEL two days in a row, yesterday and today. Patient only needed 1 shot of the vaccine. Nurse wanted to make sure that patient is not going to have any adverse reactions. Nurse said that patient missed a bunch of shots so the DAPTACEL dose yesterday was only the patient's second dose. Today's extra dose is the third. Nurse mentioned it was a medical assistant who administered both of the injections. 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.
HIB vaccine; Hepatitis A; Prevnar