Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | 3 | 785555 | OT |
child was given 4.0 ml of IPOL rather than the usual 0.5 ml, with no reported adverse event; Initial information received on 30-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 years old female patient who received 4.0 ml of IPV (VERO) [IPOL] rather than the usual 0.5 ml, 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 Measles vaccine live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3), Varicella zoster vaccine live (Oka/Merck) [Proquad] for Immunisation. On 30-Jul-2025, the patient received 4 ml of dose 3 of IPV (VERO) Suspension for injection (strength- unknown, expiry date- 31-Oct-2026 and lot 785555) via unknown route in the thigh NOS (not otherwise specified) for Immunization rather than the usual 0.5 ml, with no reported adverse event (extra dose administered) (latency- same day). 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.
Proquad