Received Nov 19, 2025
| 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 | — | — |
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | — | — |
administration of RECOMBIVAX HB Dialysis Formulation to a patient on 23OCT2025 instead of the regular adult formulation.; administration of RECOMBIVAX HB Dialysis Formulation to a patient on 23OCT2025 instead of the regular adult formulation.; RECOMBIVAX HB on 06DEC2021, 03JAN2022; Patient's titers came back "not immune"; This spontaneous report was received from a nurse and refers to a 37-years-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 06-Dec-2021, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), dose number 1, (lot # and expiration date were not reported). On 03-Jan-2022, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), dose number 2, (lot # and expiration date were not reported) (inappropriate schedule of product administration). On 06-Jun-2022, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), dose number 3, (lot # and expiration date were not reported as a prophylaxis. On 14-Oct-2025, the patient titers came back not immune (antibody NOS negative). Therefore, on 23-Oct-2025, the patient was inadvertently administrated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), (Booster dose), (lot # and expiration date were not reported) dialysis formulation to a patient instead of the regular adult formulation, as a prophylaxis (accidental overdose, wrong dosage formulation). The causal relationship between the event of antibody NOS negative and Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) was not provided. Lot # is being requested and will be submitted if received.