Received Jun 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 946912 | — |
Did Not Respond to The Series; Initial report received on 02-Jun-2026. A physician reported that a 54-year-old female (gender, race, and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and did not respond to the series. Medical history included rheumatoid arthritis. Concomitant medications included methotrexate. On 02-Feb-2026 the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 946912, expiration date, NDC #, route, and site not reported)]. On 02-Mar-2026, the patient received dose 2 of HEPLISAV-B (lot number, expiration date, NDC #, route, site not reported). On an unknown date, the patient was noted to be "in the rare population that did not respond" to the series. No additional information was reported. Company Comment: The company assessed the event as non-serious. The event is not immunologically confirmed due to lack of information on the serological test performed.; Sender's Comments: The company assessed the event as non-serious. The event is not immunologically confirmed due to lack of information on the serological test performed.
Rheumatoid arthritis
Methotrexate