Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1A191M | OT / LA |
administration of an expired vaccine with no reported adverse event; Initial information received on 06-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old male patient who had received an expired IPV (VERO) [IPOL] with no reported adverse event. This case is linked to US-SA-2025SA070267 The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles vaccine; mumps vaccine; rubella vaccine; varicella zoster vaccine, Diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), and Hepatitis B vaccine (hepatitis B vaccine) all for Immunisation. On 06-Mar-2025 at 11:00 am, the patient received an expired 0.5ml dose of suspect IPV (VERO) Suspension for injection (strength-standard, frequency-once, lot W1A191M, expiry date-16-Feb-2025) via intramuscular route in the left deltoid for Immunization, with no reported adverse event (expired product 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.; Sender's Comments: US-SA-2025SA070267:2nd patient
MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE; TDAP; HEPATITIS B VACCINE