Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 4 | Y009551 | OT |
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 3 | — | OT |
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 2 | — | OT |
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 1 | — | OT |
No symptoms reported and no additional details provided. No other AE/PQC; Caller states a patient received 3 pediatric doses prior to the age of 19, however the third dose was administered too early at 4 months instead of 6 months.; Caller states the office inadvertently administered another 0.5ml dose instead of a 1.0 ml dose; This spontaneous report was received from a nurse and refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates, prior to the age of 19, the patient was administered 3 pediatric does of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 0,5 ml administered intramuscularly for prophylaxis (lot # and expiry dates were not provided), however third dose was administered too early at 4 months instead of 6 months (inappropriate schedule of product administration). The reporter stated that as a result, the office chose to administer a booster dose to this patient that was now an adult and who already received 3 pediatric doses. On 13-May-2025, the patient was administered the fourth dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot #Y009551, expiration date: 08-Dec-2026) 0.5 mL administered intramuscularly for prophylaxis. The office inadvertently administered another 0.5ml dose instead of a 1.0 ml dose (accidental underdose). No symptoms were reported and no additional details were provided. No other adverse event (AE) or product quality complaint (PQC) was noted (no adverse event).