Received May 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1D03P1 | IM / LA |
punctured IPOL have power outage temp of 51.8 F for 1 hour and 16 minutes with no human error, has been administered post excursion with no reported adverse event; Initial information received on 06-May-2026 regarding an unsolicited valid non-serious case received from a physician. This case involves a female patient of unknown age who received IPV (Vero) [IPol] from punctured vial which was exposed to temperature excursion due to power outage at temperature of 51.8-degree Fahrenheit for 1 hour and 16 minutes with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. Concomitant medication(s) included [Varicella zoster vaccine (Varicella)]. On 04-May-2026, the patient received 0.5 mL (once) dose of IPV (VERO), Suspension for injection of standard strength (Lot Number: Y1D03P1 and Expiration Date :31-Aug-2027) via intramuscular route in left arm for immunisation. The punctured IPOL vial was exposed to a power outage with a temperature of 51.8-degree Fahrenheit for 1 hour and 16 minutes with no reported adverse event. (Poor quality product administered) (latency: same day). It was reported, "this excursion did not occur due to a human error, extended stability data did not cover the excursion, Vaccine did not have any previous 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
Varicella vaccine