Received Mar 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (PEDVAXHIB) | MERCK & CO. INC. | UNK | Y005248 | — |
No additional AE; Medical Assistant reports another HCP at their office gave PEDVAXHIB to a patient with STERILE DILUENT however PEDVAXHIB does not require reconstitution. The incident occurred as they; This spontaneous report was received from an Other health professional (medical assistant) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 18-Mar-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Suspension for injection (valid lot #Y005248, expiration date: 17-Sep-2026), 0.5 mL administered once for prophylaxis (dose number, anatomical location, and route of administration were not provided) that was incorrectly reconstituted with sterile diluent (BAXTER STERILE DILUENT, reported as DILUENT MRK) Solution for injection, formulation pre-filled syringe (valid lot #1960083, expiration date: 04-Feb-2026) at clinic. Medical Assistant reported that another health care professional (HCP) at their office gave Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) to a patient with sterile diluent (BAXTER STERILE DILUENT), however suspect vaccine did not require reconstitution (product preparation error). The incident occurred as they were vaccinating siblings, one sibling needed measles mumps and rubella vaccine (MMRII) and one needed Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), so sterile diluent (BAXTER STERILE DILUENT) was mixed into Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) and given to one patient. No side effects or symptoms were reported. The whole vial of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) was given with the sterile diluent (BAXTER STERILE DILUENT) pre-filled syringe mixed in. Only one patient was involved as other sibling received their MMRII properly. No additional adverse event (AE) was reported (no adverse event).
DILUENT MRK