Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 946904 | IM / LA |
Muscle Stiffness; Held Her Second Dose; Muscle Pain; Initial report received on 15-Sep-2025. A pharmacist reported that a 38-year-old female received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but did not receive the second dose yetand developed muscle stiffness and muscle pain. No medical history or concomitant medications were reported. On 11-Aug-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 946904; expiration date 17-Oct-2027, NDC number not available)] intramuscularly in the left deltoid. Concomitant vaccines administered included an influenza vaccine (lot # and route not provided) in the right deltoid. On 11-Aug-2025, after receiving HEPLISAV-B, the patient experienced muscle stiffness. The patient also has muscle pain when she raises her arm up and down. On 14-Sep-2025, 35 days after receiving the first dose of HEPLISAV-B, the patient presented to the pharmacy to receive the second dose. After the patient reported the muscle stiffness and muscle pain, the second dose was held and not administered. The pharmacist inquired if the patient can receive the second dose of HEPLISAV-B. No other information was available. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.