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 21Feb2023; Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that 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 21Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that 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 21Feb2023), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that 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 21Feb2023) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion that started on 21-Feb-2023).    No concomitant medications were reported. It was reported 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. Vaccine administration dates and patient information were unknown.  Excursion Timeframe, on 21-Feb-2023, Max 8.60C for 10 hours and 57 minutes, on 22-Feb-2023 Max 8.5 C for 24 hours, on 23-Feb-2023 Max 8.5 C min 7.4 C for 17 hours and 56 minutes. No treatment information was provided by the reporter. This case pertains to patient 8 th 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 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713467:Patient 1 out of 24 Patients US-MODERNATX, INC.-MOD-2023-713504:Same Reporter US-MODERNATX, INC.-MOD-2023-713484:Same Reporter US-MODERNATX, INC.-MOD-2023-713485:Same Reporter