Received Aug 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 1 | — | OT |
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 2 | — | OT |
Child was administered a 2nd dose, too early, 1 week after the first dose.; FBE said there were no adverse side effects reported.; This spontaneous report was received from a nurse and refers to an adolescent patient (also reported as child, discrepancy) of unknown exact age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), suspension for injection (dose, route of administration, lot # and expiration date were not reported) as prophylaxis; then, 1 week after the first dose, the patient was vaccinated with the second dose of this vaccine which was too early (dose, route of administration, lot # and expiration date were not reported) as prophylaxis (inappropriate schedule of product administration). No adverse side effects reported (No adverse event). Batch/Lot number is being requested and will be submitted if received.