Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1C741M | OT / RL |
Vaxelis was administered and extra dose of ipv (ipol) was also administered on the same day with no reported adverse event; Initial information received on 18-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who was administered with Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid [Vaxelis] and extra dose of Poliomyelitis Vaccine (Inactivated) (IPOL) was also administered on the same day 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 Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid [Vaxelis] for Immunisation. On 14-Mar-2025, the patient received 0.5mL of suspect IPV (Vero), Suspension for injection (lot W1C741M, expiry date 17-Nov-2025; strength standard and frequency once) via intramuscular route in right thighfor Immunisation and Vaxelis was administered and extra dose of IPV (IPOL) was also administered on the same day with no reported adverse event (extra dose administered) (latency same day). Reportedly, Office Manager called reporting that a patient was given Vaxelis and then another IPV (IPOL) on the same day and would like to know the safety or any possible adverse reactions. Action taken was 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.
VAXELIS