Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023; Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023) 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 POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023) 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 was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023) and PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023).    No concomitant medications were reported.  It was reported that vaccine had undergone temperature excursion on 21-Feb-2023, Max 8.60C for 10 hours and 57 minutes, on 22-Feb-2023. Max 8.5 C Duration: 24 hours, on 23-Feb-2023. Max 8.5 C min 7.4 C Duration: 17 hours and 56 minutes. On an unknown date, the vaccine was administered to 24 patients. No treatment medications were reported.  This case contains information for the 11th of 24 patients described by the reporter   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-2023-713471, US-MODERNATX, INC.-MOD-2023-713476, US-MODERNATX, INC.-MOD-2023-713478, US-MODERNATX, INC.-MOD-2023-713479, US-MODERNATX, INC.-MOD-2023-713480, US-MODERNATX, INC.-MOD-2023-713481, US-MODERNATX, INC.-MOD-2023-713486, 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-2023-713505 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713467:Patient 1 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713484: US-MODERNATX, INC.-MOD-2023-713485: US-MODERNATX, INC.-MOD-2023-713471: US-MODERNATX, INC.-MOD-2023-713476: US-MODERNATX, INC.-MOD-2023-713478: US-MODERNATX, INC.-MOD-2023-713479: US-MODERNATX, INC.-MOD-2023-713480: US-MODERNATX, INC.-MOD-2023-713481: US-MODERNATX, INC.-MOD-2023-713486: 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-2023-713505: