Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 2 | — | — |
Titer Drawn and it was Low; Initial report received on 21-Mar-2025. A pharmacist reported that a 57-year-old female (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had a titer drawn and it was low. Medical history and concomitant medications at the time of vaccination were not reported. On 28-Jul-2023, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot #, expiration date, NDC #, route, and site not available)]. 29-Aug-2023, 32 days after having been vaccinated with first dose of HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (Lot #, expiration date, NDC #, route, and site not available)]. On an unknown date, the patient had a titer drawn and it was low. Her physician recommended to get another dose of HEPLISAV-B. No additional information was reported. Company Comment: The company assessed the event as non-serious. The event is not immunologically confirmed for vaccination failure since the serological marker and time to serological testing was not reported.; Sender's Comments: The company assessed the event as non-serious. The event is not immunologically confirmed for vaccination failure since the serological marker and time to serological testing was not reported.