Received Apr 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1D49P1 | IM / RA |
IPOL max/low temperature reached: 10.7 c duration: 56 minutes/human error: no/reason: power outage due to weather/administered post-excursion: yes, with no reported adverse event; Initial information received on 09-Apr-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves a 10-year-old female patient who had a poor quality product POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] max/low temperature reached: 10.7 c duration: 56 minutes/human error: no/reason: power outage due to weather/administered post-excursion: yes, with no reported adverse event. The patient's past medical history, past drugs, vaccinations, family history, and concomitant medications were not provided. Concomitant medication(s) included Varicella zoster vaccine (VARICELLA). On 06-Apr-2026, the patient received a 0.5 mL once dose of IPV (VERO) [IPOL] (batch: Y1D49P1, expiry: 30-Sep-2027) (strength: standard) via intramuscular route in the right deltoid for immunization. The patient had a poor quality product administered [Poor quality product administered, onset: 06-Apr-2026, latency: same day]. The event details included a temperature excursion with maximum/low temperature reached of 10.7°C for a duration of 56 minutes due to a power outage caused by weather. The product was administered post-excursion with no reported adverse event. Human error was reported as no. 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
Varicella vaccine