Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | UNK | 946907 | IM |
Burning Hand; Initial report received on 10-Dec-2025. A nurse reported that a 46-year-old female patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced a burning in the hand. No medical history or concomitant medications were reported. On 03-Dec-2025, at 09:00 AM, the patient received an unknown dose of a hepatitis B vaccine [HEPLISAV-B (lot # 946907, expiration date 23-Nov-2027; NDC number, route, and site not available)]. On 03-Dec-2025, in the evening, the patient said that there was burning in the hand. 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.