Received Dec 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (PEDVAXHIB) | MERCK & CO. INC. | UNK | Y018677 | — |
No additional AE; Incorrect product storage; This Spontaneous report was received from Nurse and referred to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. The nurse reported a temperature excursion for haemophilus b conjugate vaccine (meningococcal protein conjugate (PEDVAX HIB) with multiple excursion that occurred over 02-Sep-2025 through 31-Oct-202; with a cumulative maximum temperature of 8.9°C for a cumulative total of 44 minutes (Incorrect product storage). A stability evaluation could not be performed during as the nurse was unable to verify if any of the products had undergone any previous temperature excursions. On 30-Sep-2025, the patient was inadvertently vaccinated with for haemophilus b conjugate vaccine (meningococcal protein conjugate (PEDVAX HIB) lot number Y018677 (expiration date not reported, but upon internal validation established as 10-Apr-2027) for prophylaxis (dose, route of administration and anatomical location were not reported). Any adverse issues or side effects adverse issues or side effects.