Received Oct 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 945665 | IM / LA |
On September 2, 2025, a 15-year-old patient received a dose of Heplisav-B (Hepatitis B Vaccine [Recombinant], Adjuvanted) at our pharmacy. The vaccine was administered in error, as Heplisav-B is not FDA-approved for individuals under 18 years of age. The error was identified on October 29, 2025, when the patient returned for a second Hepatitis B vaccination. At the time of discovery, the patient was asymptomatic and in good health, with no adverse effects or complications reported since the initial administration. The patient?s parent/guardian was informed of the error and advised that the dose may not count toward completion of the Hepatitis B series. The parents reported that the patient does not currently have a pediatrician. They were counseled to establish care with a healthcare provider. Per current clinical data and CDC guidelines, the decision was made to administer two doses of Recombivax HB 10 mcg (1.0 mL) intramuscularly at month 0 and 4-6 months to appropriately complete the Hepatitis B vaccination series. No treatment or medical intervention was required. The patient continues to remain healthy and symptom-free. The event has been documented internally for quality assurance review, and staff have been re-educated to verify vaccine age indications prior to administration.
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