Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 3 | — | SC / RA |
Received Second Dose of Heplisav-B In May 2025, Received A Third Dose One Day Later; Extra Dose Administered; Arm Soreness; Rash on the Right Arm at Site of Subcutaneous Injection; Received dose 2 Subcutaneously; Initial report received on 25-Sep-2025. A consumer reported that she, a female, received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization subcutaneously one day later she received a third dose intramuscularly, experienced arm soreness after each dose, and developed a rash on the right arm. Medical history included an allergy to sulfa. No concomitant medications were reported. In May 2025, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC # not reported)] subcutaneously in the right arm. The patient had arm soreness and developed a rash on the right arm at the subcutaneous dose site. In May 2025, approximately one day after having with the second dose of HEPLISAV-B, the patient received a third dose of HEPLISAV-B (lot #, expiration date, NDC #, and site not reported)] intramuscularly. The patient had arm soreness after the dose was given. The event of rash on the right arm lasted "a few weeks" and has since resolved. No other information was provided.; Sender's Comments: The company assessed the events as non-serious.
Drug allergy (Sulfa)