Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1A201M | OT |
patient received ipol in the left leg and pediarix right leg. the ipol dose was an extra dose against polio because pediarix contains a dose against polio as one of its components with no reported ae; Initial information received on 05-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 weeks old male patient who received IPV (VERO) [IPOL] in the left leg and pediarix right leg the ipol dose was an extra dose against polio because pediarix contains a dose against polio as one of its components with no reported ae (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, Diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid, Tetanus vaccine toxoid (Pediarix), HIB vaccine (HIB vaccine) and Rotavirus vaccine for Immunisation. On 05-May-2025, the patient received IPV (VERO) dose 0.5 ml 1x(once) Suspension for injection lot Y1A201M expiry date-31-Jan-2027 via unknown route in the left leg for Immunization (strength unknown) and pediarix right leg. the ipol dose was an extra dose against polio because pediarix contains a dose against polio as one of its components with no reported ae (extra dose administered) (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.
Pediarix; HIB vaccine; Rotavirus vaccine