Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1C891M | OT / RA |
temperature excursion of ipol; max/low temperature reached: 46.7 f (8. 2 c)for 20 minutes, which was administered post excursion with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves temperature excursion of IPV (Vero) [IPOL]; max/low temperature reached: 46.7 f (8. 2 c) for 20 minutes, which was administered to a 18 years old female patient, post excursion 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 Influenza vaccine [Fluzone (Influenza Vaccine)]; and Meningococcal vaccine A/C/Y/W conj (Tet Tox) (Menquadfi) both for Immunisation. On 11-Mar-2025, caller reported that 0.5ml dose of suspect IPV (VERO) (opened), Suspension for injection (Strength Standard) (Frequency once) lot X1C891M with Expiry date 31-Oct-2026, via intramuscular route in the right arm for Immunization, was exposed to a max/low temperature reached: 46.7 f (8. 2 c) for 20 minutes was administered to patient with no reported adverse event (poor quality product administered) (Latency Same day). Reportedly, Product/s: fluzone NP, menquadfi and IPOL (Unopened), IPOL (opened); Reason: Power outage; Human error: no; Administered post-excursion: yes; Previous Excursion: none; Does extended stability data cover the excursion: No, for opened IPOL. 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.
FLUZONE [INFLUENZA VACCINE]; Menquadfi