Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 946063 | IM / RA |
Given HEPLISAV-B When They were 14 Years Old; Initial report received on 06-Aug-2025. A pharmacist reported that a 14-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On 17-Apr-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 946063, expiration date 31-Aug-2027; NDC number not available) intramuscularly in the right arm. The patient was 14 years old at the time of immunization. No side effects 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.