Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | — | — |
Pediatric Patient (7 day old) Received Heplisav-B; Initial report received on 12-Feb-2025. A medical assistant reported that a 7-day-old (gender, race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On 12-Feb-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available)]. The patient was 7 days old when vaccinated with HEPLISAV-B. No adverse reactions were reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.