Received Jun 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | UNK | — | — |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | — | OT |
No additional AE; report inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion; This spontaneous report was received from a nurse practitioner and refers to a 5-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-MAY-2025, diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis b [recombinant] vaccine (VAXELIS) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# not reported) underwent a temperature excursion (1.4 degree Celsius, 18 minutes). There was no previous temperature excursions. On 21-MAY-2025, the patient was inadvertently vaccinated with improperly stored diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis b [recombinant] vaccine (VAXELIS) suspension for injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) and with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution administered by oral route (dose, lot # and expiration date were not reported) for prophylaxis (Product storage error). No additional adverse event was reported (No adverse event). Lot# is being requested and will be submitted if received.