Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 3 | Y014090 | OT |
The patient did not experience any symptoms; patient accidentally received their third dose of RECOMBIVAXHB prior to the suggested 6 months of age; HCP called to report that a patient accidentally received their third dose of RECOMBIVAXHB prior to the suggested 6 months of age; This spontaneous report was received from a healthcare professional regarding a 4-month-old female patient. The patient's medical, concurrent conditions, and concomitant therapies were not reported. On 11-JUL-2025, the patient was accidentally vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) injection, 0.5 mL administered intramuscularly as prophylaxis (lot number reported as Y014090, which has been verified as valid, expiration date reported and validated as 01-JUN-2027) (anatomical site of injection was not reported). This vaccine was administered prior to the suggested 6 months of age (Inappropriate schedule of product administration, Product administered to patient of inappropriate age). The patient did not experience any symptoms.