Received Oct 13, 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 | — | — |
No additional AE; doses were given too close together; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 12-May-2011, the patient was vaccinated with first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), 0.5 mL, administered for prophylaxis (route, anatomical site, lot # and expiration date were not reported). On 28-Jul-2011, the patient was vaccinated with second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), 0.5 mL, administered for prophylaxis (route, anatomical site, lot # and expiration date were not reported). On 13-Sep-2011, the patient was vaccinated with third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), 0.5 mL, administered for prophylaxis (route, anatomical site, lot # and expiration date were not reported). The vaccine doses were given too close together (Inappropriate schedule of product administration). No symptoms reported. No additional adverse event (AE) (No adverse event). Lot# is being requested and will be submitted if received.