Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; fridge being out of range on 12/02/22 for one hour; patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (fridge being out of range on 12/02/22 for one hour) and NO ADVERSE EVENT (No adverse event) in an 8-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. On 02-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (fridge being out of range on 12/02/22 for one hour). In December 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (fridge being out of range on 12/02/22 for one hour) 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 POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened) and PRODUCT TEMPERATURE EXCURSION ISSUE (fridge being out of range on 12/02/22 for one hour).    No concomitant products reported.  It was reported that the fridge was being out of range on 02 Dec 2022 for one hour. The reporter was advised to go on the Temperature Excursion Tool which she did and it said no action required. HCP 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 on 16 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.   No treatment products reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-695843, US-MODERNATX, INC.-MOD-2023-695834, US-MODERNATX, INC.-MOD-2023-695859, 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: Non significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695843:Same reporter US-MODERNATX, INC.-MOD-2023-695834:Same reporter US-MODERNATX, INC.-MOD-2023-695859: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