Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | UNK | 945665 | IM |
Arm is Yellow on the Underside Both Above the Elbow and Bellow the Elbow; Initial report received on 03-Jul-2025. A pharmacist reported that a female patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient's underside of her arm both above and below the elbow was yellow. No medical history or concomitant medications were reported. On 02-Jul-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 945665, expiration date 03-Jan-2027, and NDC number 43528-0003-05; site not available) intramuscularly. On 03-Jul-2025, 1 day after receiving HEPLISAV-B, the patient reported her arm is yellow on the underside both above and below the elbow. No other adverse effects 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.