Received Nov 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 946913 | IM / RA |
16 Year Old Received HEPLISAV-B; Initial report received on 07-Nov-2025. A medical assistant reported that a 16-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. Medical history included the patient previously receiving a three dose series of an unknown hepatitis B vaccine in early childhood of which the patient was not showing immunity based on titers drawn on an unknown date. No concomitant medications were reported. On 06-Nov-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 946913, expiration date 02-Mar-2029, and NDC number 43528-003-01)] intramuscularly in the right deltoid. The patient was 16 years and 8 months old at the time of vaccination. The patient was accidentally prescribed HEPLISAV-B. 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.