Received Jan 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | — | — |
Caller had initially requested information regarding side effects associated with providing an adult dose (1.0 mL) to a pediatric patient.; No adverse event; This spontaneous report was received from a health professional and refers to a pediatric 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 was vaccinated with an adult dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), Injection 1 mL (1.0 mL), (administration route, anatomical site, lot # and expiration date were not reported) indicated as prophylaxis (Incorrect dose administered). No additional adverse event was provided. The outcome of the events was not provided. The action taken with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), was not applicable.