Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: our fridge being out of range on 12/02/22 for one hour; No adverse event; pediatric patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happned; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour), POOR QUALITY PRODUCT ADMINISTERED (pediatric patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happned) and NO ADVERSE EVENT (No adverse event) in an 11-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In December 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (pediatric patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happned). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour), POOR QUALITY PRODUCT ADMINISTERED (pediatric patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happned) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour) and POOR QUALITY PRODUCT ADMINISTERED (pediatric patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happned).    Concomitant medication list was not provided. It was reported that 10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened. One patient was vaccinated on 09-Dec-2022 and 9 patients were vaccinated on16-Dec-2022. Excursion happened on 02-Dec-2022. during 1 hour and minimum temperature reached was 1.2 A degree C. No adverse events were reported. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-695834, US-MODERNATX, INC.-MOD-2023-695859, US-MODERNATX, INC.-MOD-2023-695862, US-MODERNATX, INC.-MOD-2023-695864, US-MODERNATX, INC.-MOD-2023-695865, US-MODERNATX, INC.-MOD-2023-695867, US-MODERNATX, INC.-MOD-2023-695868, US-MODERNATX, INC.-MOD-2023-695869, US-MODERNATX, INC.-MOD-2023-695870 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2023: Live follow up: non significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695834:Same reporter US-MODERNATX, INC.-MOD-2023-695859:Same reporter US-MODERNATX, INC.-MOD-2023-695862:Same reporter US-MODERNATX, INC.-MOD-2023-695864:Same reporter US-MODERNATX, INC.-MOD-2023-695865:Same reporter US-MODERNATX, INC.-MOD-2023-695867:Same reporter US-MODERNATX, INC.-MOD-2023-695868:Same reporter US-MODERNATX, INC.-MOD-2023-695869:Same reporter US-MODERNATX, INC.-MOD-2023-695870:Same reporter US-MODERNATX, INC.-MOD-2023-695869:Same reporter