Received Jul 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | — | — |
No other AE/No PQC.; HCP called stating that a male 16 year old patient was inadvertently given the adult formulation 1mL dose of RECOMBIVAX HB "last week". No further information provided. No other AE/No PQC. 1 mL RECOMBIVAX - last week male 00006-4094-02; This spontaneous report was received from a Physician and refers to a 16-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On an unknown date in July 2025 (reported as last week), the patient was inadvertently vaccinated with an adult formulation of Hepatitis B Vaccine (Recombinant) 10MCG/1.0ML Injection, at a dose of 1mL, prefilled syringe, administered as prophylaxis (route of administration, anatomical site of injection, lot number and expiration date were not reported) (Accidental overdose). No additional adverse event was reported for the patient. No further information provided.