Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 945659 | IM / RA |
Chest Tightness; Difficulty Breathing; Feverish; Initial report received on 13-Mar-2025. A nurse reported that a 33-year-old male (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced chest tightness, difficulty breathing, and felt feverish. No medical history or concomitant medications were reported. On 05-Mar-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot # 945659, 31-Jan-2025, NDC # 43528-003-05)] intramuscularly in the right deltoid. Concomitant vaccines administered included an unknown dose of a typhoid vaccine (Lot #, expiration date, NDC #, route not reported)] in the right deltoid, and an unknown dose of a hepatitis A vaccine (Lot #, expiration date, NDC #, route not reported) in the left deltoid. The vaccines were given in preparation for travel. On 07-Mar-2025, the patient called and reported that he went to the ER with chest tightness and difficult breathing. The patient also reported feeling feverish. The patient had "testing" completed at the ER which ruled out any potential issues. The patient was discharged home. 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.