Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Bivalent 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 17 patients on unknown dates.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent Vaccine 6 months to 5 years underwent temperature excursion started on 21-Feb-2023), POOR QUALITY PRODUCT ADMINISTERED (They were to be used within 24 hours but administered to 17 patients on unknown dates.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent Vaccine 6 months to 5 years underwent temperature excursion started on 21-Feb-2023), POOR QUALITY PRODUCT ADMINISTERED (They were to be used within 24 hours but administered to 17 patients on unknown dates.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent Vaccine 6 months to 5 years underwent temperature excursion started on 21-Feb-2023), POOR QUALITY PRODUCT ADMINISTERED (They were to be used within 24 hours but administered to 17 patients on unknown dates.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (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 (Bivalent Vaccine 6 months to 5 years underwent temperature excursion started on 21-Feb-2023) and POOR QUALITY PRODUCT ADMINISTERED (They were to be used within 24 hours but administered to 17 patients on unknown dates.).    No concomitant medications were reported.  Vaccines were to be used within 24 hours but administered to 17 patients on unknown dates. Excursion Timeframe were reported as 21-Feb-2023, Max 8.60C for 10 hours and 57 minutes, 22-Feb-2023. Max 8.5 C Duration 24 hours and 23-Feb-2023 Max 8.5 C min 7.4 C Duration 17 hours and 56 minutes.  No treatment information was provided.  This case contains information for the 16 of 17 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713728, US-MODERNATX, INC.-MOD-2023-713756, US-MODERNATX, INC.-MOD-2023-713757, US-MODERNATX, INC.-MOD-2023-713760, US-MODERNATX, INC.-MOD-2023-713748, US-MODERNATX, INC.-MOD-2023-713747, US-MODERNATX, INC.-MOD-2023-713751, US-MODERNATX, INC.-MOD-2023-713742 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713728:Patient 1 (master case) US-MODERNATX, INC.-MOD-2023-713760: US-MODERNATX, INC.-MOD-2023-713748: US-MODERNATX, INC.-MOD-2023-713757: US-MODERNATX, INC.-MOD-2023-713756:Patient no 16 US-MODERNATX, INC.-MOD-2023-713742:Patient no 16 US-MODERNATX, INC.-MOD-2023-713751: US-MODERNATX, INC.-MOD-2023-713747: