Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | — | — |
Chills 24 Hours a Day; Initial report received on 12-Sep-2025. A consumer reported that a male patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced chills 24 hours a day. No medical history or concomitant medications were reported. On 08-Sep-2025, the patient received dose 1 of hepatitis B vaccine [HEPLISAV-B (lot, expiration date, NDC, site and route not reported)]. On 08-Sep-2025, after having been vaccinated with HEPLISAV-B, the patient has had chills 24 hours a day. 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.