Received Jul 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1A201M | OT / RL |
patient received both the Vaxelis and IPOL yesterday, with no reported adverse event; Initial information received on 08-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old male patient who was received both the vaxelis and IPV (VERO) [IPOL] yesterday, 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, HIB vaccine conj (menigococcal protein), Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Vaxelis); Rotavirus vaccine live oral 1v (Rotarix) and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) all for prophylactic vaccination (Immunisation). On 07-Jul-2025, the patient received a dose of 0.1 ml of suspect IPV (VERO), suspension for injection (lot Y1A201M and expiry date: 31-Jan-2027) (strength: standard and frequency: once) via intramuscular route in the right thigh for immunization and also received vaxelis yesterday with no reported adverse event (extra dose administered) (Latency: same day). Reportedly, The patient's mother did not bring him to the clinic for his 2-month old physical examination, so patient only received his first dose of Vaxelis yesterday. 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.; Sender's Comments: US-SA-2025SA193061:Vaxelis
Vaxelis; Rotarix; Prevnar 20