Received May 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | 3CA30C1 | IM / LA |
expired dose of ADACEL was administered to a patient, with no reported adverse event; Initial information received on 04-May-2026 regarding an unsolicited valid non-serious case received from other unknown healthcare professional. This case involves a 13-year-old female patient who received an expired dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. Concomitant medications: Menveo On 04-May-2026, the patient received a 0.5 mL of an expired diphtheria-2/tetanus/5 AC pertussis vaccine suspension for injection (batch number: 3CA30C1, expiration date: 30-Apr-2026) (strength: standard) via intramuscular route in left deltoid for immunization with no reported adverse event (Expired product administered, and 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 medication 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.
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