Received Dec 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Y018582 | — |
No additional AE/No PQC; Medical Assistant reported administration of improperly stored vaccines to multiple patients beginning on 10/2/2025; This spontaneous report was received from a medical assistant and refers to a 1-year-old patient. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 27-Oct-2025, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) (involved lot # was Y018582, expiration date not provided but upon internal validation established as 03-Jul-2026); 0.5 mL, administered for prophylaxis (route and site of administration were not provided). Temperature excursion (TE) was below 34.3 Fahrenheit degrees (F) for 3 hours 57 minutes 30 seconds on 02-OCT-2025, below 34.8 F for unknown at time of call, below 34.7 F for 7 hours 45 minutes 0 seconds on 15-OCT-2025, below 35 F for unknown at time of call. The reporter called back, and TE was completed with another agent while this AE case was being worked on, TE case noted with caller stating that the two unknown dates/temps were a mistake, and that there were only two excursion dates. There was no previous temperature excursion nor report of adverse effect or product quality complaint involved. This is one of multiple cases from the same reporter.