Received Jan 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | — | — |
diagnosed with HEP B; died because he did not have immunity; This spontaneous report was received from a physician, concerning a 51-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), (dose, route, lot # and expiration date were not reported), as prophylaxis. On an unknown date, the patient was diagnosed with Hepatitis B (Hepatitis B) and had a liver transplant as treatment. It was reported that with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) did not have sustained immunity (Vaccination failure). On an unknown date, the patient died due to Hepatitis B, since he did not had immunity (also reported as died because he did not have immunity). The causal relationship between the event Hepaitis B and Hepatitis B Vaccine (Recombinant) was not provided. The event of vaccination failure was determined to be related to Hepatitis B Vaccine (Recombinant) Upon internal review, the event of Hepatitis B was determined to be medically significant. Lot# would be requested and submitted if received.; Reported Cause(s) of Death: diagnosed with HEP B who had to get a liver transplant and died because he did not have immunity