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Report #2851448

Received Jul 28, 2025

A note on interpretation. VAERS reports are unverified and may be incomplete or coincidental. A report does not establish that a vaccine caused an event, and counts should not be used to calculate incidence or infer causation. Full disclaimer

Overview

Sex
Female
Age
64 yrs
State
UT
Recovered
Unknown
Vaccinated
Jul 17, 2025
Onset
Jul 17, 2025
Days to onset
0
Hospital days
—

Vaccines (1)

TypeNameManufacturerDoseLotRoute / Site
HEPHEP B (HEPLISAV-B)DYNAVAX TECHNOLOGIES CORPORATIONUNK946065IM / RA

Symptoms (2)

No adverse eventProduct storage error

Symptom narrative

Given HEPLISAV-B that Went Out of Temperature Range for 3 1/2 Hours; Initial report received on 22-Jul-2025. A healthcare coordinator reported that a 64-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had been out of temperature range for 3.5 hours. No medical history or concomitant medications were reported. On 17-Jul-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 946065, expiration date 02-Nov-2027, and NDC number 43528-000 3-01) intramuscularly in the right deltoid. The HEPLISAV-B dose given was out of temperature range for 3.5 hours with a temperature low of -0.2 degrees Celsius. No other side effects reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.