Received Feb 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (PEDVAXHIB) | MERCK & CO. INC. | UNK | Y006392 | — |
No adverse event; Caller reported AE on behalf of a patient who was administered improperly stored PEDVAXHIB on 2/4/2025 that experienced a TE on 1/31/2025. No symptoms reported. No additional AE details reported. Obtained consent to contact HCP. TE Filed (Case; This spontaneous report was received from a nurse referring to a patient, age and gender not provided. Information regarding the patient's pertinent medical history, drug allergies or reactions, or concomitant medications was not provided. On 04-FEB-2025, the patient was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PEDVAX) injection, 0.5 ml for prophylaxis (route of administration, vaccination scheme frequency, anatomical location were not reported, lot number Y006392 with and expiration date on 08-NOV-2025). The administered dose of the vaccine experienced a temperature excursion 10.22 degrees Celsius for 22 hours and 50 minutes. It was not reported if the information was recorded by a data logger or not. There was no adverse effect reported.