Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Nurse manager reporting that Bivalent Vaccine underwent temperature excursion started on 21-Feb-2023 and was administered on an unknonw date; Nurse manager reporting that Bivalent Vaccine 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 (Nurse manager reporting that Bivalent Vaccine underwent temperature excursion started on 21-Feb-2023 and was administered on an unknonw date), PRODUCT TEMPERATURE EXCURSION ISSUE (Nurse manager reporting that Bivalent Vaccine 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 (Nurse manager reporting that Bivalent Vaccine underwent temperature excursion started on 21-Feb-2023 and was administered on an unknonw date), PRODUCT TEMPERATURE EXCURSION ISSUE (Nurse manager reporting that Bivalent Vaccine 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 (Nurse manager reporting that Bivalent Vaccine underwent temperature excursion started on 21-Feb-2023 and was administered on an unknonw date), PRODUCT TEMPERATURE EXCURSION ISSUE (Nurse manager reporting that Bivalent Vaccine 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 (Nurse manager reporting that Bivalent Vaccine underwent temperature excursion started on 21-Feb-2023 and was administered on an unknonw date) and PRODUCT TEMPERATURE EXCURSION ISSUE (Nurse manager reporting that Bivalent Vaccine underwent temperature excursion started on 21-Feb-2023).    No concomitant medications were reported.  Nurse manager reported that 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. Vaccine administration dates and patient information were unknown. Excursion Timeframe was reported on 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 minutes.  No treatment medications were reported.  This case contains information for the 2nd 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-2023-713748, US-MODERNATX, INC.-MOD-2023-713757, US-MODERNATX, INC.-MOD-2023-713760, US-MODERNATX, INC.-MOD-2023-713746, US-MODERNATX, INC.-MOD-2023-713749, US-MODERNATX, INC.-MOD-2023-713750, US-MODERNATX, INC.-MOD-2023-713754, US-MODERNATX, INC.-MOD-2023-713755, US-MODERNATX, INC.-MOD-2023-713756, US-MODERNATX, INC.-MOD-2023-713758, US-MODERNATX, INC.-MOD-2023-713759, US-MODERNATX, INC.-MOD-2023-713761, US-MODERNATX, INC.-MOD-2023-713762, US-MODERNATX, INC.-MOD-2023-713747, US-MODERNATX, INC.-MOD-2023-713751 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713728:Patient no 1 US-MODERNATX, INC.-MOD-2023-713756:Patient no 11 US-MODERNATX, INC.-MOD-2023-713748:Patient no 5 US-MODERNATX, INC.-MOD-2023-713757:Patient no 12 US-MODERNATX, INC.-MOD-2023-713760:Patient no 15 US-MODERNATX, INC.-MOD-2023-713746:Patient no 3 US-MODERNATX, INC.-MOD-2023-713749:Patient no 6 US-MODERNATX, INC.-MOD-2023-713750:Patient no 7 US-MODERNATX, INC.-MOD-2023-713754:Patient no 9 US-MODERNATX, INC.-MOD-2023-713755:Patient no 10 US-MODERNATX, INC.-MOD-2023-713756:Patient no 11 US-MODERNATX, INC.-MOD-2023-713758:Patient no 13 US-MODERNATX, INC.-MOD-2023-713759:Patient no 14 US-MODERNATX, INC.-MOD-2023-713761:Patient no 16 US-MODERNATX, INC.-MOD-2023-713762:Patient no 17 US-MODERNATX, INC.-MOD-2023-713747:Patient no 4 US-MODERNATX, INC.-MOD-2023-713751:Patient no 8