Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | UNK | — | — |
Hyperpigmentation On The Face; Initial report received on 21-May-2025. This report was retrieved from a social media post. A consumer reported that a patient (gender, race, and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the developed hyperpigmentation on their face. No medical history or concomitant medications were reported. On an unknown date, the patient received an unspecified dose of hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available). One day following administration of the vaccine, the patient underwent a laser hair removal procedure. After the procedure, the patient developed hyperpigmentation on their face. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.