Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 944918 | IM / LA |
Received Heplisav-B In Late February, and A Second Dose of Engerix Pediatric Dose Today; Initial report received on 27-Mar-2025. A medical assistant reported that a 57-year-old female (race, ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) as the first dose for hepatitis B immunization and received ENGERIX-B as the second dose. No medical history or concomitant medications were reported. On 11-Feb-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot# 944918, NDC # 43628-0003-05, expiration date not available)] intramuscularly in the left deltoid. On 27-Mar-2025, 44 days after having been vaccinated with HEPLISAV-B, the patient was given a pediatric dose of a hepatitis B vaccine [ENGERIX-B (Lot#, expiration date, site and route not reported)].. 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.