Received Feb 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (PEDVAXHIB) | MERCK & CO. INC. | UNK | Y006392 | — |
No additional AE; 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 #02749; This spontaneous report has been received from a nurse, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 04-FEB-2025, the patient was vaccinated with an improperly stored dose of with improperly storage dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) at a dose of 0.5 milliliter (ml), lot number Y006392 which was determined to be valid, with an expiration date on 08-NOV-2026) as prophylaxis (vaccination scheme, route of administration, and anatomical site of injection were not reported). Administered doses were stored at a temperature of 10.22 degrees Celsius (C), during a time frame of 22 hours and 50 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported in the patient.