Received Apr 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 947358 | IM / LA |
11 Year Old Who was Accidentally Given HEPLISAV-B; Initial report received on 17-Mar-2026. A nurse reported that an 11-year-old female accidentally received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On 16-Mar-2026, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 947358, expiration date 17-May-2028, and NDC number 43528-003-05)] intramuscularly in the left deltoid. The patient is an 11-year-old who was accidentally given HEPLISAV-B. The patient was at a well-visit and standard vaccination schedule visit and was accidentally administered HEPLISAV-B. The patient's mother was notified, who confirmed the patient had experienced no adverse effects. 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.