Received Dec 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 945665 | IM / LA |
Patient Received A Dose of Heplisav-B, and Was Mistakenly Given Engerix-B For The Second Dose; Initial report received on 09-Dec-2025. A pharmacist in the US (AZ) reported that a 19-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then ENGERIX-B as the second dose. No medical history or concomitant medications were reported. On 21-Oct-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 945665, expiration date 31-Jan-2027, and NDC number 43528-003-06)] intramuscularly in the left deltoid. On 03-Dec-2025, 43 days after receiving HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [ENGERIX-B (lot number 47D3S)] intramuscularly in the left deltoid. The patient was mistakenly given ENGERIX-B as the second dose. HEPLISAV-B was received at another pharmacy location. 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.
Engerix-b