Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | — | LA |
Numbness On Left Side Of Body Experienced After Heplisav-B Injection; Initial report received on 05-Sep-2025. A consumer reported that she, a 36-year-old female, received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced numbness to the left side of the body. The patient had received the hepatitis B vaccine series previously, but was not sure which she had. No concomitant medications were reported. On 11-Aug-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, and not reported)] intramuscularly in the left deltoid. The patient had started a new job and received the series because her hepatitis B titer was low. On 12-Aug-2025, 1 day after being vaccinated with HEPLISAV-B, the patient experienced numbness in the left elbow and arm extending down to the torso, then down to the left leg. It progressed to numbness of the entire left side of her body, from the top of her head down to her toes. The patient reported that the numbness in her hand comes and goes, while the rest of her arm remains numb. She stated there is a decrease in sensation but no tingling. She went to the Emergency Room (ER) to rule out a stroke. The patient underwent a CT scan of the head and cervical spine without contrast, which did not show any acute findings or changes. The reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Test Name: CT Scan; Result Unstructured Data: Nothing acute, no changes; Comments: Of head and cervical spine without contrast