Received Feb 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | P7EE2 | — |
No additional AE; HCP called to report inadvertent administration of expired RECOMBIVAX HB to a patient. Vaccine expired on 09MAR2019 and was administered to a patient on 11MAR2019. No additional information was known by reporter. No additional AE/PQC.; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported. On 11-MAR-2019, the patient received inadvertent administration of expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, invalid lot P7EE2, expiration date: 09-MAR-2019, administered for prophylaxis (dosage, route of administration, and anatomical location were not provided) (Expired product administered). No additional adverse event was reported. This is non-valid because the patient is not identifiable. Follow-up information has been received from the nurse on 05-FEB-2025. It was confirmed that the patient was a 5-year-old male. This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2236723. The previous case ID: 2501USA003629. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report.