Received Jul 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (IMOVAX) | SANOFI PASTEUR | UNK | 5PA40P1 | IM / LA |
IMOVAX highest/lowest temperature reached: 0°C,duration of excursion: 3 hours,reason: the vaccines were placed in the freezer, and product was used, with no reported adverse event; Initial information received on 25-Jun-2026 regarding an unsolicited valid non-serious case received from a physician. This case involves a 48-year-old female patient and reporter reported RABIES (HDC) VACCINE [IMOVAX RABIES], highest/lowest temperature reached: 0°C, duration of excursion: 3 hours, reason: the vaccines were placed in the freezer, and product was used, with no reported adverse event. The patient's past medical history, past drug history, vaccination(s), family history, were not provided. No other immunizations A physician reported a temperature excursion, highest/lowest temperature reached: 0°C, duration of excursion: 3 hours, reason: the vaccines were placed in the freezer, and product was used on 23-Jun-2026. The patient received a 1 mL once dose of RABIES (HDC) VACCINE [IMOVAX RABIES] powder and solvent for suspension for injection (batch number: 5PA40P1, expiry date: 31-Mar-2028) (strength: standard) via intramuscular route in Left Deltoid for immunization with no reported adverse event (product storage error). The vaccines were placed in the freezer; the highest/lowest temperature reached was 0°C; human error was confirmed as yes; the duration of excursion was 3 hours; there was no previous excursion; extended stability data did not cover the excursion; and the product was administered post-excursion. Action taken: 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.
Comments: NONE