Received May 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U85648A | IM / RA |
75-years-old received Adacel who was above the recommended age with no reported adverse event; Initial information received on 17-Apr-2026 regarding an unsolicited valid non-serious case received from other or unknown health care professional (HCP). This case involves a 75-year-old male patient who received diphtheria, tetanus and acellular pertussis vaccine (ADACEL) who was above the recommended age with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 17-Apr-2026, the patient received diphtheria, tetanus and acellular pertussis vaccine (ADACEL) suspension for injection (strength: standard) as 0.5 mL once intramuscularly in Right deltoid for immunization, who was above the recommended age with no reported adverse event (Product administered to patient of inappropriate age) (latency same day) (batch: U85648A, expiry date: 30-Jun-2027). . No adverse event reported at the time of the report 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.
Comments: NONE