Received Feb 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 2 | 4CA03C2 | OT / RA |
administration of daptacel to a patient over 7 years old with no reported adverse event; Initial information received on 03-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 years 11 months old male patient reporter reported administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] to a patient over 7 years old 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;VARICELLA ZOSTER VACCINE; Hepatitis a vaccine (Hepa), Hepatitis b vaccine (Hep) and PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (20-VALENT, ADSORBED) for Immunisation. On 19-Jan-2026, the patient over 7 years old received dose 2 of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (dose 0.5 ml) frequency once (strength standard) lot 4CA03C2 expiry date-31-Oct-2026 via intramuscular route in the right deltoid for immunization with no reported adverse event (product administered to patient of inappropriate age) (latency same day). 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.
MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE; Hepa; Hep; PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (20-VALENT, ADSORBED)