Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; Vaccine administered following temperatur excursion; This spontaneous report was received from a nurse and referred to multiple patients of unknown age and gender.  The patients' medical history, concurrent conditions, drug reactions and allergies, and concomitant therapies were not reported.  On 11-DEC-2023, the patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (recombinant human albumin [rHA]) (lot number X000792 has been verified to be a valid lot number, expiration date reported and validated as 07-JUL-2024; lot number X019300  has been verified to be a valid lot number, expiration date reported and validated as 14-JAN-2025); and with varicella virus vaccine live (oka/merck) (VARIVAX) injection, (lot number X011424 has been verified to be a valid lot number, expiration date reported and validated as 19-APR-2025), both vaccines were administered as prophylaxis after two temperature excursions (that happened on unspecified date), the first one (reported as  a previous temperature excursion) of -12 Celsius degrees (C) (-14C to -10C) during a timeframe of 15 minutes and the second excursion of -12 Celsius degrees (C) (-14C to -10C) during a timeframe of 15 minutes, with a cumulative time of 30 minutes (product storage error) (vaccination details such as dose number, dose, strength, vaccination scheme, anatomical location and route of administration were not provided). There was no additional adverse event reported.  This case was considered non-valid due to multiple patients and lack of patients' identifiers.  Follow-up information was received from a nurse on 04-JAN-2024  It was confirmed that the report referred to a 15-month-old female patient. Additionally, it was reported that at the time, it was reported that refrigerator/freezer needed to be repaired, therefore, all the vaccines were moved to a different office (located 10-minutes-walking-distance). The vaccines were transported in a cooler filled with ice, in both ways. Furthermore, it was reported that the dose administered was the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) and the lot number X011429 (expiration date 19-APR-2025) (previously reported as was X011424 ) was an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX) and said vaccine was administered to the patient in the right thigh; moreover, it was reported that and no measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered to the patient.   Also, on 11-DEC-2023, the patient was vaccinated with the fourth dose (reported that there had been 3 previous doses) of Haemophilus influenzae type B vaccine (HIB), administered in the left thigh,  lot# US863AA, (expiration date: 25-MAR-2024) (manufacturer: Sanofi) (strength, dose, frequency, formulation, lot #, route of administration, and indication were not provided); diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), administered in the left thigh, lot# GG39D, (expiration date: 07-JUN-2025) (manufacturer: SKB) (strength,dose number, dose, frequency, formulation, lot #, route of administration, and indication were not provided); and  influenza vaccine (FLU VACCINE), administered in the right thigh, lot# 373195, (expiration date: 30-JUN-2024) (manufacturer: SEQ) (strength, formulation, lot #, route of administration, and indication were not provided). It was mentioned that after temperature excursion, the vaccines were safe to use.  Additionally, the patient's demographics were updated.  This case was considered valid as patient's identifiers were provided.