Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | 2 | W1B511M | OT / LA |
temperature excursion of ipol; max/low temperature reached: 47.1°f duration: 10 mins with no reported adverse event; Initial information received on 28-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 10 years old female patient who received IPV (VERO) [IPOL] which was exposed to temperature excursion and max/low temperature reached: 47.1°f duration: 10 mins 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, mumps vaccine, rubella vaccine (MMR) for Immunisation; Varicella zoster vaccine (Varicella vaccine) for Immunisation; Hepatitis B vaccine for Immunisation; and Hepatitis A Vaccine for Immunisation. On 25-Feb-2025, the patient received 0.5 ml of dose 2 of IPV (VERO) Suspension for injection with standard strength (expiry date- 08-Sep-2025 and lot W1B511M) once via intramuscular route in the left deltoid for Immunization which was exposed to temperature excursion and max/low temperature reached: 47.1°f duration: 10 mins with no reported adverse event (product storage error) (latency- same day). Reportedly, reporter said that they were transferring the vaccines from their AccuVax to their fridge that was 10 feet away. There was no previous excursion. Human error was involved. 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.
MMR; Varicella vaccine; HEPATITIS B VACCINE; HEPATITIS A VACCINE