Received Jul 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 1 | — | OT |
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 2 | — | OT |
no additional AE; HCP reports pediatric (0.5ml) dose of RECOMBIVAX HB was inadvertently given to an adult patient today 07/15/2025.; This spontaneous report has been received from a medical assistant and refers to an adult (exact age was not provided) patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided. On an unknown date in June 2025, the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) suspension for injection, 1 ml (adult dose) (route of administration, anatomical location, lot# and expiry date were not provided), for prophylaxis. On 15-JUL-2025, the patient was inadvertently vaccinated with the second dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB), 0.5 ml (pediatric dose) (Accidental underdose). No additional adverse event was provided. Lot# is being requested and will be submitted if received.