Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 2 | — | — |
Feeling Terrible After Receiving Vaccines; Initial report received on 18-Sep-2025. A male patient, reported that he received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and felt terrible. Medical history included previous vaccination with ENGERIX-B (total of 6 rounds completed) over the last 25 years with no immunity. No concomitant medications were reported. On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, site and route not reported)]. On an unknown date, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, site and route not reported)]. Concomitant vaccines administered included flu vaccine (lot #, expiration date, NDC #, site and route not reported)] and COVID-19 vaccine (lot #, expiration date, NDC #, site and route not reported)]. On an unknown date, after having been vaccinated with HEPLISAV-B, the patient reported feeling terrible after receiving all three vaccines co-administered together. Symptoms were not specified. No additional information is available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.