Age: 6.0
Sex: F
Vaccine: DTAPIPV, FLU3, HEPA, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called to report temperature excursion for the following vaccines:  VAQTA, PEDVAXHIB, ROTATEQ, and GARDASIL 9.  Upon reviewing excursion questions, Nurse stated unsure if vaccines had been administered as the vaccines had several prior excursio; This spontaneous report was received from nurse and refers to a unknown patients.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X017317, expiration date: 13-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided); hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X017083, expiration date: 13-DEC-2024 (strength, route of administration, and indication were not provided); rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1947620, expiration date: 01-MAY-2024, administered orally for prophylaxis (strength was not provided); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W034363, expiration date: 14-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided); and  hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X010373, expiration date: 13-NOV-2024, administered for prophylaxis (strength, and route of administration were not provided). Those vaccines underwent multiple temperature excursions as follows: on 20-DEC-2023 in 1.6 (units not provided) for 1  hour 47 minutes, on 21-DEC-2023 in 1.1 degree Celsius for 3 hours 41 minutes, on 22-DEC-2023 in 1.0 (units not provided) for 5 hours 24 minutes, on 23-DEC-2023 in 1.4 (units not provided) for 4 hours 25 minutes, on 24-DEC-2023 in 1.4 degree Celsius for 4 hours 47 minutes, on 25-DEC-2023 in 1.4 (units not provided) for 4 hours 24 minutes, on 25-DEC-2023 in 1 (units not provided) for 5 hours 36 minutes, on 27-DEC-2023 in 0.3 (units not provided) for 4 hours 37 minutes, 28-DEC-2023 in 1.7 (units not provided) for 4 hours 8 minutes, on 29-DEC-2023 in 1.7 (unites not provided) for 1 hour 44 minutes, on 30-DEC-2023 in 1.8 (units not provided) for 3 hours 21 minutes, on 31-DEC-2023 in 1.8 (units not provided) for 3 hours 19 minutes, on 01-JAN-2024 in 1.8 (unites not provided) for 3 hours 11 minutes, on 02-JAN-2024 in 1.6 (units not provided) for 3 hours 3 minutes, on 03-JAN-2024 in 1.5 (units not provided) for 2 hours 57 minutes andon 04-JAN-2024 in 1.9 (units not provided) for 34 minutes (Product storage error). No additional adverse event was reported.  Follow-up information was received on 17-JAN-2024:  The case 2401USA000094 was turned to be valid, the patient's identifiers were provided.  This spontaneous report as received from a nurse refers to a 6-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 28-DEC-2023, the patient was vaccinated with an improperly stored doses of hepatitis a vaccine, inactivated (VAQTA), formulation: intramuscular injection, lot # X017083, expiration date: 13-DEC-2024, intramuscular in the left deltoid (exact dose was not provided); measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: injection, lot # X011437, expiration date: 18-JUL-2024, intramuscular in the left deltoid (exact dose was not provided); diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) (GSK), lot # reported as 7343J, expiration date was reported as: 25-JAN-2025, intramuscular in right deltoid (formulation and exact dose were not provided); and influenza vaccine(FLUZONE [INFLUENZA VACCINE]) (Sanofi Pasteur), lot # was reported as U78240MA, expiration date was reported as 30-JUN-2024m intramuscular in the right deltoid for prophylaxis.  It was reported that the vaccines storage unit temperature excursion was identified after vaccines administered on 28-DEC-2024. Administered doses of vaccines were exposed to the temperature excursion on 20-DEC-2023 of 1.6 (units not provided); on 21-DEC-2023 of 1.1 C for 3 hours and 41 minutes; on 22-DEC-2023 of 1.0 (units not provided) for 5 hours and 24 minutes; on 23-DEC-2023 of 1.4 (units not provided) for 4 hours and 25 minutes; on 24-DEC-2023 of 1.4 C for 4 hours and 47 minutes; on 25-DEC-2023 of 1.0 (units not provided) for 5 hours and 36 minutes; on 27-DEC-2023 of 0.3 (units not provided) for 4 hours and 37 minutes; on 28-DEC-2023 of 2.4 (units not provided) for 4 hours and 8 minutes (product storage error). No additional adverse event reported (no adverse event).