Received Sep 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 4 | Y007989 | — |
| 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 reported side effects.; Caller also stated the 3rd dose was administered late; 2 year old child was administered an additional dose of RECOMBIVAX HB; This spontaneous report was received from a nurse and refers to a 2-year-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 an unknown date, the patient started therapy with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), Suspension for injection, dose number 1, (lot # and expiration date, route of administration and anatomical location were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), Suspension for injection, dose number 2, (lot # and expiration date, route of administration and anatomical location were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), Suspension for injection, dose number 3, (lot # and expiration date, route of administration and anatomical location were not reported) for prophylaxis and that dose was administered late (Inappropriate schedule of vaccine administered). On 11-AUG-2025, the patient was vaccinated with additional dose of Hepatitis B Vaccine (Recombinant) Suspension for injection (RECOMBIVAX HB) (lot #Y007989 was valid for formulation pre-filled syringe, expiration date: 06-DEC-2026, dose number 4, route of administration and anatomical location were not reported) for prophylaxis (Extra dose administered). No additional information to report. No reported side effects (No adverse event). No product quality complaint (PQC).