Received Jul 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | UNK | 947931 | IM |
Temperature Excursion for a Total of Six Days, Four Patients Received it After the Excursion; Initial report received on 15-Jul-2025. A nurse reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the product had a temperature excursion for a total of 6 days. No medical history or concomitant medications were reported. On 20-Jun-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 947931, expiration date 15-May-2027, and NDC number 43528-003-01) intramuscularly. The reporter noted a temperature excursion for a total of 6 days prior to the vaccination. No adverse reactions were 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.