Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | — | — |
HEPLISAV-B was Administered to a Child Under 18 Years Old; Initial report received on 24-Oct-2025. A physician reported that a 9-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. The patient was under 18 years old when HEPLISAV-B was administered. No medical history or concomitant medications were reported. On 24-Oct-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. The patient was under 18-years-old at the time of vaccination. 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.