Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | — | — |
Face Swelling, 2-3 Times Larger; Eye Swelling; Redness All Over; 1st Injection in July 2024 and Never Returned; Hives All Over; Initial report received on 18-Mar-2025. A reporter reported that a 22-year-old female (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced incomplete course of vaccination, facial swelling, eye swelling, hives all over, and redness all over. No medical history or concomitant medications were reported. In Jul-2024, dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, site and route not reported)]. The patient never returned for the next dose. On 18-Feb-2025, dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, site and route not reported)] to begin a new series. On 18-Mar-2025, 28 days after the first dose, dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot # 945663, expiration date 31-Jan-2027, NDC # not reported) was administered intramuscularly in the right deltoid. On 18-Mar-2025, two hours after injection, the patient came back to the clinic with facial swelling (described as 2-3 times larger), eye swelling, hives all over, and redness all over. The patient was treated with 50 mg of BENADRYL (diphenhydramine) intramuscularly. The patient left the facility with a parent. No other information was reported. Company Comment: ?The company assessed the events as non-serious.; Sender's Comments: ?The company assessed the events as non-serious.