Received Apr 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1A212M | IM / RA |
Only the punctured IPOL was administered to 1 patient post excursion with no adverse event; Initial information received on 09-Apr-2026 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 7-year-old male patient who received IPV (VERO) [IPOL] post excursion with no adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. Concomitant medication(s) included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix). On 08-Apr-2026, the patient received a 0.5 mL once dose of IPV (VERO) suspension for injection (batch: Y1A212M, expiry: 31-Jan-2027) (strength: standard) via intramuscular route in right deltoid for Immunisation post excursion with no reported adverse event (Poor quality product administered) (latency- same day). Reason: Unknown; They're looking into it. Max/Low Temperature reached: 1.3C Duration out of labelled range: 360 minutes or 6 hours Human Error: Unknown. Does extended stability data cover the excursion: No for punctured IPOL. 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.
Boostrix