Received May 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | 3CA17C1 | OT / LA |
patient was not given the full dose, as some of the medication spilled down the arm of the patient with no reported adverse event; patient was not given the full dose, as some of the medication spilled down the arm of the patient with no reported adverse event; Initial information received on 14-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old male patient who had experienced an event was not given the full dose of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] vaccine, as some of the medication spilled down the arm of the patient 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 Meningococcal vaccine A/C/Y/W conj (tet tox), (Menquadfi); and HPV vaccine VLP rL1 4v (yeast) (Gardasil). On 14-May-2025, the patient received a less than 0.5 ml dose once (1x) of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine suspension for injection (batch number: 3CA17C1, expiry date: 28-Feb-2026) via intramuscular route in the left deltoid for prophylactic vaccination. On 14-MAY-2025 the patient was not given the full dose, as some of the medication spilled down the arm of the patient with no reported adverse event (accidental exposure to product) (exposure via skin contact) (latency: 1 day) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. Action taken: not applicable. It was not reported if the patient received a corrective treatment for both the events At time of reporting, the outcome was Unknown for both the events. 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.
MENQUADFI; GARDASIL