Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023; Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023), POOR QUALITY PRODUCT ADMINISTERED (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023), POOR QUALITY PRODUCT ADMINISTERED (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023), POOR QUALITY PRODUCT ADMINISTERED (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023) 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 (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023) and POOR QUALITY PRODUCT ADMINISTERED (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023).    The concomitant medication was not reported by reporter. It was reported that Nurse manager reporting that Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023. They were to be used within 24 hours but administered to 24 patients on unknown dates. The vaccine administration dates, and patient information were unknown. The excursion timeframe 21-Feb-2023, Max 8.60C for 10 hours and 57 minutes, on 22-Feb-2023, Max 8.5 C and duration was 24 hours. On 23-Feb-2023, Max 8.5 C min 7.4 C and duration 17 hours and 56 minutes. The treatment medication was not reported by reporter.  This case was for the Patient 16 out of 24 Patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-713467, US-MODERNATX, INC.-MOD-2023-713484, US-MODERNATX, INC.-MOD-2023-713485, US-MODERNATX, INC.-MOD-2023-713504, US-MODERNATX, INC.-MOD-2023-713471, US-MODERNATX, INC.-MOD-2023-713476, US-MODERNATX, INC.-MOD-2023-713480, US-MODERNATX, INC.-MOD-2023-713481, US-MODERNATX, INC.-MOD-2023-713486, US-MODERNATX, INC.-MOD-2023-713487, US-MODERNATX, INC.-MOD-2023-713488, US-MODERNATX, INC.-MOD-2023-713489, US-MODERNATX, INC.-MOD-2023-713490, US-MODERNATX, INC.-MOD-2023-713492, US-MODERNATX, INC.-MOD-2023-713493, US-MODERNATX, INC.-MOD-2023-713494, US-MODERNATX, INC.-MOD-2023-713495, US-MODERNATX, INC.-MOD-2023-713498, US-MODERNATX, INC.-MOD-2023-713499, US-MODERNATX, INC.-MOD-2023-713500, US-MODERNATX, INC.-MOD-2023-713502, US-MODERNATX, INC.-MOD-2023-713505 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713467:Patient 1 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713485:Same Reporter US-MODERNATX, INC.-MOD-2023-713504: US-MODERNATX, INC.-MOD-2023-713484:Same Reporter US-MODERNATX, INC.-MOD-2023-713471: US-MODERNATX, INC.-MOD-2023-713476: US-MODERNATX, INC.-MOD-2023-713480: US-MODERNATX, INC.-MOD-2023-713481: US-MODERNATX, INC.-MOD-2023-713486: US-MODERNATX, INC.-MOD-2023-713487: US-MODERNATX, INC.-MOD-2023-713488: US-MODERNATX, INC.-MOD-2023-713489: US-MODERNATX, INC.-MOD-2023-713490: US-MODERNATX, INC.-MOD-2023-713492: US-MODERNATX, INC.-MOD-2023-713493: US-MODERNATX, INC.-MOD-2023-713494: US-MODERNATX, INC.-MOD-2023-713495: US-MODERNATX, INC.-MOD-2023-713498: US-MODERNATX, INC.-MOD-2023-713499: US-MODERNATX, INC.-MOD-2023-713500: US-MODERNATX, INC.-MOD-2023-713502: US-MODERNATX, INC.-MOD-2023-713505: