Received Apr 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | UNK | — | — |
I Did Not Have Any Immunity; Initial report received on 13-Mar-2025. A consumer reported that she, an 84-year-old female (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and did not have any immunity. The patient has an allergy to penicillin that results in swelling under tongue. No concomitant medications were reported. On an unknown date, the patient received 2 doses of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available). The patient stated that after having her hepatitis B vaccine, she did not have any immunity. She was not completely sure she was given HEPLISAV-B, but she thought it was a 2-dose vaccine. No other information was available. Company Comment: The company assessed the event as non-serious and not immunologically confirmed for vaccine failure. The dosing schedule and serological marker and time to testing were not reported.; Sender's Comments: The company assessed the event as non-serious and not immunologically confirmed for vaccine failure. The dosing schedule and serological marker and time to testing were not reported.
Penicillin allergy (Swelling under tongue)