Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X15141M | OT / RA |
punctured IPOL was administered to 1 patient post temperature excursion with no reported adverse event; Initial information received on 06-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 38 years old male patient who was administered with punctured IPV (VERO) [IPOL] - post temperature excursion with no reported adverse event. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix; Varicella zoster vaccine (Varicella vaccine); Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr); Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) and Influenza vaccine (Flu), all for Immunisation. On an unknown date, the patient had administered 0.5mL standard dose of suspect IPV (Vero), Suspension for injection (lot X15141M, expiry date 31-Oct-2026 and frequency: once) via subcutaneous route in the right arm for Immunisation and the patient was administered with punctured poliomyelitis vaccine (inactivated) - post temperature excursion with no reported adverse event (poor quality product administered). Action taken was not applicable. Reportedly, temperature excursion that occurred on the night of 04-Feb-2025. Reason: Power outage, Max/low temperature reached: MAX = 8.1 C LOW = 4.6C, Duration: 18 minutes. Human error was no. All products except punctured IPOL was covered and it was administered to a patient. 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.
Boostrix; Varicella vaccine; Mmr; Heplisav b; Flu