Received Feb 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 4CA34C1 | OT / LA |
8 year old patient received a dose of daptacel with no adverse event; Initial information received on 24-Feb-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 8 years old male patient who received a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Prophylactic vaccination (Immunisation). On 10-Feb-2026, the patient received a dose 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection (lot 4CA34C1 and expiry 31-MAY-2027) via intramuscular route in the left deltoid for immunization with no adverse event (product administered to patient of inappropriate age) (latency same day) (strength:-standard). 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.
HEPATITIS B VACCINE; HEPATITIS A VACCINE