Received Jun 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 947341 | IM / RA |
Itchy Reaction; Rash; Initial report received on 09-Jun-2026. A consumer reported that she, a female (age, race, and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced itchiness and rash. No medical history was reported. No concomitant medications were reported. On 30-Apr-2026, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 947341, expiration date, NDC number, route not reported)] in the right arm. On 31-Apr-2026, after having been vaccinated with HEPLISAV-B, the patient developed a "kind of itchy reaction." She thought she had a sunburn and later thought that the reaction may have been related to laundry detergent; but she reported that she was sure it was like having hives or eczema. At the time of reporting, the reaction had been ongoing for nearly 6 weeks. It reportedly comes and goes. The reaction was initially located on her back and then extended around to the front. The reaction was worse under the bra, appeared like a bite, and if scratched became more of a rash. The rash was nowhere around the injection site. The consumer was evaluated by a dermatologist and was treated with 5 mg cortisone cream for 2 weeks, however the cream had not been effective. On 08-Jun-2026, the patient contacted her healthcare provider and had a blood test performed that morning. Results were not yet available. A follow-up appointment with the healthcare provider was scheduled. At the time of the report, the outcome of the itchy reaction and rash had not resolved. 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.