Received Jul 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | UNK | 946065 | IM / RA |
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.