Received Dec 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | UNK | — | — |
HEPLISAV-B was Given to a 1 day old Neonate; Initial report received on 13-Nov-2025. A pharmacist reported that a 1-day-old neonate received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On an unknown date, the patient received a dose of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available). The patient was a 1-day-old neonate at the time of immunization. No adverse 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.