Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | 1 | — | — |
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 1 | Y004552 | — |
No additional AE reported.; Customer called and reported that at a 2 month well baby checkup, a 1 month and 30-day old consumer inadvertently received the RECOMBIVAX HB concomitantly with the VAXELIS vaccine. No additional AE reported. No PQC reported. No additional information; This spontaneous report was received from a nurse and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-Apr-2025, the patient was vaccinated with a dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot #Y004552, expiration date: 14-Oct-2026) (dose, route of administration and vaccination site were not reported) for prophylaxis; and with a dose of Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Outer Membrane Protein Complex), and Hepatitis B (Recombinant) Vaccine (VAXELIS) (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered from prophylaxis. On that day, a 1 month and 30-day old consumer inadvertently received the Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) concomitantly with the Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Outer Membrane Protein Complex), and Hepatitis B (Recombinant) Vaccine (VAXELIS) (overdose). No additional adverse event (AE) was reported (no adverse event). No product quality complaint (PQC) was reported. No additional information was provided. Lot # is being requested and will be submitted if received.; Reporter's Comments: