Received Dec 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 946909 | IM |
13 Year Old Patient Received A Dose of Heplisav-B; Initial report received on 01-Dec-2025. A nurse reported that a 13-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On 10-Nov-2025, the patient received a dose of a hepatitis B vaccine [HEPLISAV-B (lot number 946909, expiration date 26-Jan-2025, and NDC number 43528-003-05; site not provided)] intramuscularly. The patient was 13 years old at the time. No adverse 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.