Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 946064 | IM / LA |
HEPLISAV-B Exposed to a Temperature 32.8 C and Out of Range For 93 Hours, And It Was Administered to a Patient; Initial report received on 11-Sep-2025. A pharmacist reported that a 57-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had been exposed to a temperature above 27°C. No medical history or concomitant medications were reported. On 10-Sep-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 946064; expiration date 31-Aug-2027, and NDC # not reported)] administered intramuscularly in the left deltoid. The HEPLISAV-B had been exposed to a temperature above 27°C. The product was exposed to a temperature of 32.8°C and was out of range for 93 hours. The patient did not experience any adverse events after receiving HEPLISAV-B. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Test Date: 20250923; Test Name: Blood Pressure; Comments: Hypotensive