Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (PEDVAXHIB) | MERCK & CO. INC. | 1 | X028614 | — |
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | 1 | Y005465 | — |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 1 | Y009341 | OT |
No additional AE reported; T/E for PEDVAX HIB , ROTATEQ, VAXNEUVANCE that was administered; This spontaneous report was received from a nurse, concerning to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-FEB-2025, a the vaccines Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), and Pneumococcal 15-valent Conjugate Vaccine (Vaxneuvance); suffered a temperature excursion (TE) of 2 hours and 12 minutes at 32.0 F. On 25-Feb-2025, the patient was vaccinated with the vaccines involved in the TE: first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #Y009341 has been verified to be valid for this vaccine, expiration date reported and confirmed as 24-Nov-2025), administered orally; with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #X028614 has been verified to be valid for this vaccine, expiration date reported as 24-Nov-2025 and confirmed as 05-Jul-2026) (dose and route of administration not provided); and with the first dose of pneumococcal 15-valent Conjugate Vaccine (Vaxneuvance) (lot #Y005465 has been verified to be valid for this vaccine, expiration date reported and confirmed as 08-Jan-2027) (dose and route of administration not provided). All of them administered as prophylaxis. (Product storage error). No additional adverse events were reported (No adverse event).