Received Nov 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HBHEPB | HIB + HEP B (COMVAX) | MERCK & CO. INC. | UNK | Z003041 | — |
No symptoms reported. No additional AE; HCP reported that one dose of PEDVAX HIB which was improperly stored was administered. No symptoms reported. No additional AE/no PQC. ? Names of vaccines involved (including lot/exp) PEDVAX HIB Z003041 10/04/2027 ? Temperature In; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-Oct-2025 (discrepant information also reported as 24-Oct-2027), the patient was vaccinated with and improper storage dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #Z003041, expiration date: 04-Oct-2027) 0.5 mL (anatomical location and administration route were not reported) for the treatment of Prophylaxis. The temperature information of the excursion was unknown by the reporting nurse, as the temperature was not monitored. It was confirmed that two current temperature excursions occurred. For both, the product was in a cooler with ice packs. The first excursion was for 14 minutes. The second excursion was for 15 minutes, and no previous temperature excursions occurred. No symptoms or additional adverse events were reported.