Received Dec 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Acute hepatitis B infections reported among appropriately vaccinated; Information has been received from the authors in a literature spontaneous article referenced below concerning to a 18 -year-old patient of unknown gender. The patient's concurrent conditions included HIV infection, Hepatitis B surface antibody Negative, HBsAg- negative, IgM core anti body reactive, and elevated liver function test results. The patient's past medications were not reported. The patient's concomitant medications were not reported. On an unknown date, the patient started therapy with hepatitis B vaccine (strength, dose, route, dose number, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date, although the patient received the three doses of hepatitis B vaccine with appropriate intervals, the patient develop chronic hepatitis B (vaccination failure) occurred from 2018 to 2023 (exact dates not provided) The Outcome of acute hepatitis B infection was not provided. The causal relationship between vaccination failure and hepatitis B vaccine was reported as related. Literature Report: A copy of the published article is attached as further documentation of the patient/s experience.
Anti-HBs antibody negative; Hepatitis B surface antibody negative (between 11 months and six years prior to acute hepatitis B infection); Hepatitis B virus core antigen IgM antibody positive; HIV infection; Liver function test increased