Received Sep 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8564A | OT / LA |
patient got additional adacel in error , with no reported adverse event; Initial information received on 12-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old female patient who was administered with an additional dose of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] in error, 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 live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3), Varicella zoster vaccine live (Oka/Merck) (Proquad), Polio vaccine (Polio), Hepatitis a vaccine (Hepatitis A) and Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for Immunisation. On 04-Sep-2025, the patient received 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, lot U8564A, expiry date: 23-Feb-2027, via unknown route in the left arm For prophylactic vaccination (immunisation) On 11-Sep-2025, patient also received an additional extra 0.5 ml dose of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, Strength: standard, frequency: once (lot, expiry date and strength not reported) via unknown route in the left arm for prophylactic vaccination (immunisation) in error with no reported adverse event (extra dose administered) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence Reportedly, the error occurred due to the patient has two charts; that another chart was used on the 11-Sep-2025; that chart did not show that the consumer just had the vaccination on 04-Sep-2025. 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.
Proquad; Polio; Hepatitis A; Menquadfi