Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 1 | — | — |
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 2 | — | — |
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 3 | — | — |
HCP reported to FBE that "she did not show immunity to the HEPATITIS B vaccine after 3 doses".; This spontaneous report was received from a nurse referring to herself a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On an unknown dates, the patient was vaccinated with first dose of hepatitis B vaccine (recombinant) (manufacturer unknown), then with second dose, and subsequently with third dose, completing 3 doses vaccination scheme (strength, dose, anatomical site of injection, vaccination scheme frequency, lot number and expiration date were not reported) as prophylaxis. On an unknown date, the patient she did not show immunity to the hepatitis B vaccine after 3 doses (Hepatitis B antibody negative). The outcome of the event of hepatitis B antibody negative was not provided. The causal relationship between the event of hepatitis B antibody negative and hepatitis B vaccine (recombinant) (manufacturer unknown) was not reported.