Age: 1.83
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No Adverse event; 3 doses administered from vials that underwent a temperature excursion; 3 doses administered from vials that underwent a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) in a 22-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Sep-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses administered from vials that underwent a temperature excursion). On 22-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses administered from vials that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion).    No concomitant medication information was provided.  No vaccines in this lot have been administered since the temperature excursion.  Date of excursion was 02-Sep-2022 and duration of the excursion was1 hour. There were no remaining doses. Storage condition at the time of the excursion was frozen storage. Individual vials or unbroken cartons was in the box. Vial size was 2.5 ml. Maximum or minimum temperatures reached was maximum minus 12.5 degree Celsius. No date was provided for vials moved from freezer to refrigerator. Visual inspection showed no change in any vaccine state. Vial does not undergo any temperature excursions.  Reportedly, The affected vaccine inventory encountered a temperature excursion for approximately one hour on 02-Sep-2022 while reporter were doing vaccine inventory and during that time were exposed to a maximum temperature of minus 12.5 degrees Celsius. Additionally In-house stability data indicate that so long as it was now back within minus 50 degree to minus 15 degree Celsius, the vaccine experiencing the conditions reported was expected to remain stable to its published expiry. The vaccines were considered as viable. Each patient received one dose each and no information received from patient or families of any adverse reactions.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654338, US-MODERNATX, INC.-MOD-2022-654059, US-MODERNATX, INC.-MOD-2022-654306, US-MODERNATX, INC.-MOD-2022-654318, US-MODERNATX, INC.-MOD-2022-654323, US-MODERNATX, INC.-MOD-2022-654332 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2022: Follow-up received updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654338:same reporter US-MODERNATX, INC.-MOD-2022-654059:same reporter US-MODERNATX, INC.-MOD-2022-654306:same reporter US-MODERNATX, INC.-MOD-2022-654318:same reporter US-MODERNATX, INC.-MOD-2022-654323:same reporter US-MODERNATX, INC.-MOD-2022-654332:same reporter