Received Sep 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | — | SYR / LA |
Given HEPLISAV-B In Their Vein; Pain At The Injection Site; Soreness At The Injection Site; Initial report received on 25-Aug-2025. A pharmacist reported that a 21-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in her vein and experienced soreness and pain at the injection site. No medical history or concomitant medications were reported. On 18-Jul-2025, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, and NDC number not available) intravenously in the left deltoid. The patient reported that she received HEPLISAV-B in her vein instead of her deltoid at her pharmacy. Documentation of the immunization showed that the patient received HEPLISAV-B in the left deltoid. The administering technician confirmed the patient received the product in her left deltoid and not a vein. On an unknown date, the patient received dose 2 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available. On an unknown date, after receiving HEPLISAV-B, the patient experienced soreness and pain at the injection site. No additional information was reported Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.