Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Product storage error/our fridge being out of range on 12/02/22 for one hour; No adverse event; 10 pediatric patients vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened; 10 pediatric patients 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 (10 pediatric patients vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (10 pediatric patients vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT STORAGE ERROR (Product storage error/our fridge being out of range on 12/02/22 for one hour) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (10 pediatric patients vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened). On 09-Dec-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error/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, POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (10 pediatric patients vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT STORAGE ERROR (Product storage error/our 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) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (10 pediatric patients vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened) and PRODUCT STORAGE ERROR (Product storage error/our fridge being out of range on 12/02/22 for one hour).    No concomitant medications were reported. HCP stated 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 09Dec2022 and 9 patients were vaccinated on 16Dec2022. Excursion happened on 02Dec2022 during 1 hour and minimum temperature reached was 1.2°C. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-695843, US-MODERNATX, INC.-MOD-2023-695862 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2023: Live Significant Follow up appended-Patient Information, Vaccination date, Narrative updated. On 09-Jan-2023: Live Follow-up received contains no new information..; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695843:Same reporter US-MODERNATX, INC.-MOD-2023-695862:Same reporter