Received Sep 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 1 | — | — |
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 2 | — | — |
No adverse event; HCP calling to report a 12 year old patient has received first two doses of RECOMBIVAX HB outside of the 3 dose series regimen within the Prescribing Information. Caller stated patient received first dose in March of 2025, second dose in August 2025; This spontaneous report was received from a Physician and refers to a(n) 12-year-old female patient. The patient's medical history , concurrent conditions and concomitant therapies were not reported. In March 2025, the patient started therapy with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), dose number 1, 0.5 mL as prophylaxis (route of administration, lot # and expiration date were not reported). In August 2025, the patient started therapy with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), dose number 2, 0.5 mL as prophylaxis (route of administration, lot # and expiration date were not reported) (Inappropriate schedule of vaccine administered). No adverse event reported. The reporter stated that they only wanted to receive answer to their question that they asked and did not want to provide information for adverse event report. Caller stated that the patient was in their office and they just want to give her the shot and if she had to report every patient that had received a vaccine outside of the schedule then the company should change their policy. Lot # is being requested and will be submitted if received.