Received May 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 2 | 945664 | IM / LA |
A Red Face; Shortness of Breath; Itchiness; Hives; Initial report received on 17-Apr-2025. A reporter reported that a 19-year-old female (ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed hives, a red face, itchiness, and shortness of breath. No medical history was reported. No concomitant medications were reported. On 16-Apr-2025, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot #945664, expiration date 31-Jan-2027, NDC # 43528-003-01)] intramuscularly in the left deltoid. On an unknown date, after receiving dose 2 of HEPLISAV-B, the patient developed hives, a red face, itchiness, and shortness of breath. No other side effects were reported. 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.