Received May 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8906AA | IM |
ADACEL prefilled syringe leaked from the syringe tip after needle attachment but right before administration,more than half the dose leaked out with exposure to patient's skin, with no reported adverse event; ADACEL prefilled syringe leaked from the syringe tip after needle attachment but right before administration,more than half the dose leaked out with exposure to patient's skin, with no reported adverse event; Initial information received on 07-May-2026 regarding an unsolicited valid non-serious case received from a nurse (healthcare professional). This case involves a 63-year-old male patient who had DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] prefilled syringe that leaked from the syringe tip after needle attachment but right before administration, more than half the dose leaked out with exposure to patient skin, with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 04-May-2026, the patient received a 0.5 mL once dose of ADACEL suspension for injection PRE-FILLED SYRINGE (batch: U8906AA, expiry: 31-May-2028) strength: standard via intramuscular route in left upper arm for immunisation (Immunisation) that leaked from the syringe tip after needle attachment but right before administration, more than half the dose leaked out with exposure to patient skin, with no reported adverse event (Accidental exposure to product and Exposure via skin contact) (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 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