Sex: U
Vaccine: 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; Bivalent 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 POOR QUALITY PRODUCT ADMINISTERED (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), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent 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 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 POOR QUALITY PRODUCT ADMINISTERED (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), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent 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, POOR QUALITY PRODUCT ADMINISTERED (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), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent 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 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 POOR QUALITY PRODUCT ADMINISTERED (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) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent Vaccine 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023).    Concomitant medications details were not reported by the reporter. Nurse manager reported that Bivalent Vaccine 6 months to 5 years. underwent temperature excursion started on 21Feb2023.They were to be used within 24 hours but administered to 17 patients on unknown dates. Vaccine administration dates and patient information were unknown. Excursion Timeframe: 21-Feb-2023, Max 8.60C for 10 hours and 57 minutes, 22-Feb-2023. Max 8.5 C Duration 24 hours, 23-Feb-2023 Max 8.5 C min 7.4 C Duration: 17 hours and 56. Treatment details was not reported by the reporter.  This case contains information of patient number 14 out of 17.   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:Master case (Crosslink case with same reporter) US-MODERNATX, INC.-MOD-2023-713747:Same reporter US-MODERNATX, INC.-MOD-2023-713756:Same reporter US-MODERNATX, INC.-MOD-2023-713748:Same reporter US-MODERNATX, INC.-MOD-2023-713757:Same reporter US-MODERNATX, INC.-MOD-2023-713760:Same reporter US-MODERNATX, INC.-MOD-2023-713751:Same reporter US-MODERNATX, INC.-MOD-2023-713742:Same reporter