Received Sep 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | z004729 | — |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | Z004726 | — |
wrong vaccine; No additional AE; Product lot number issue; This spontaneous report has been received from a pharmacist, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On an unknown date, the patient was vaccine with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #Z004726, expiration date: 31-Oct-2026) or Hepatitis B Vaccine (Recombinant) (lot number z004729, expiration date) On an unknown date, the patient started therapy with Hepatitis B Vaccine (Recombinant) (lot #z004729) (expiration date ), both as prophylaxis, also it was reported a possible PQC, it was reported that lot #z004726 which was documented 70 times as administered doses for RECOMBIVAX HB, this agency placed the HCP on hold and caller with employee who stated lot# z004726 was associated with ROTATEQ and not RECOMBIVAX HB. The employee said he was unable to provide or confirm the NDC number for lot z004726 though so the NDC number was still unknown. The caller was informed the lot # z004726 was for ROTATEQ and the caller then provided additional details saying he had doses of RECOMBIVAX HB with the lot #z004729, but that he doesn't suspect this was user error as the lot #z004726. (Wrong product administered, Product lot number issue). No additional adverse events were reported in the patient. This case was determined to be non-valid due to the lack of patient identifiers.; Sender's Comments: Priority : 5 , Is case serious : No , number : 02864013-02863993 , number : , number : , number : 500UW00000k5Y55YAE|29082025170007|3316 , Central date : 2025-08-29 , Classification : , Attachment description : Call , Safety case number : , case number : 02864013 , interaction number : 02863993 , Integration log UniqueID : 500UW00000k5Y55YAE|29082025170007|3316 , Service cloud CaseID : 500UW00000k5Y55YAE