Received Feb 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | — | IM |
Second Dose of HEPLISAV-B Not Received; Rash; Red Skin; Initial report received on 05-Feb-2025. A reporter reported that a 48-year-old female (ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed red skin and rash. No medical history or concomitant medications were reported. On 22-Aug-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC # 43528-002-01, site not available)] intramuscularly. At the time of reporting, more than a year after receiving the first dose, the patient presented to receive the second dose, but the site would not administer it. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.