Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
patient who had already received a tdap vaccine in 2022 at an outside clinic. they stated that the additional tdap dose, adacel, was administered, with no reported adverse event; Initial information received on 20-Nov-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 23 years old male patient who had already received a tdap vaccine in 2022 at an outside clinic. they stated that the additional DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] dose, was administered, 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 Influenza vaccine inact split 3v (Afluria); and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. On an unknown date in 2022, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (lot number, strength, dose and expiry not reported) via unknown route in unknown administration site. On 19-Nov-2025 he also received another dose with dosage 0.5 ml of vaccine (Lot: UT8669AA, expiry: 30-Sep-2027, Strength: Standard) via intramuscular route in the left deltoid as Immunization, additional tdap dose, was administered, with no reported adverse event (extra dose administered) (Latency: same day) following the second dose administration. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported, "the patient had not reported any adverse events". 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.
Afluria; PFIZER BIONTECH COVID-19 VACCINE