Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 23-Dec-2022; No adverse event; Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) 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. 216K22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 26-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022).    Concomitant medication was not provided.  It was reported that the vial size was 0.4 ml per vial. The vial was initially stored in refrigerator on 23-Dec-2023. The vial did not undergo any temperature excursion. Treatment information was not provided.  This case contains information for the 1st patient out of 42 pediatric patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718304, US-MODERNATX, INC.-MOD-2023-718309, US-MODERNATX, INC.-MOD-2023-718310, US-MODERNATX, INC.-MOD-2023-718312, US-MODERNATX, INC.-MOD-2023-718319, US-MODERNATX, INC.-MOD-2023-718334, US-MODERNATX, INC.-MOD-2023-718315, US-MODERNATX, INC.-MOD-2023-718337, US-MODERNATX, INC.-MOD-2023-718333, US-MODERNATX, INC.-MOD-2023-718340, US-MODERNATX, INC.-MOD-2023-718313, US-MODERNATX, INC.-MOD-2023-718317, US-MODERNATX, INC.-MOD-2023-718335, US-MODERNATX, INC.-MOD-2023-718341, US-MODERNATX, INC.-MOD-2023-718343, US-MODERNATX, INC.-MOD-2023-718318, US-MODERNATX, INC.-MOD-2023-718342, US-MODERNATX, INC.-MOD-2023-718332, US-MODERNATX, INC.-MOD-2023-718344, US-MODERNATX, INC.-MOD-2023-718347, US-MODERNATX, INC.-MOD-2023-718345, US-MODERNATX, INC.-MOD-2023-718339, US-MODERNATX, INC.-MOD-2023-718356, US-MODERNATX, INC.-MOD-2023-718359, US-MODERNATX, INC.-MOD-2023-718331, US-MODERNATX, INC.-MOD-2023-718346, US-MODERNATX, INC.-MOD-2023-718363, US-MODERNATX, INC.-MOD-2023-718349, US-MODERNATX, INC.-MOD-2023-718351, US-MODERNATX, INC.-MOD-2023-718352, US-MODERNATX, INC.-MOD-2023-718361, US-MODERNATX, INC.-MOD-2023-718360, US-MODERNATX, INC.-MOD-2023-718358, US-MODERNATX, INC.-MOD-2023-718367, US-MODERNATX, INC.-MOD-2023-718350, US-MODERNATX, INC.-MOD-2023-718353, US-MODERNATX, INC.-MOD-2023-718355, US-MODERNATX, INC.-MOD-2023-718390, US-MODERNATX, INC.-MOD-2023-718391, US-MODERNATX, INC.-MOD-2023-718392, US-MODERNATX, INC.-MOD-2023-718394, US-MODERNATX, INC.-MOD-2023-718350, US-MODERNATX, INC.-MOD-2023-718353, US-MODERNATX, INC.-MOD-2023-718355 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718334:patient no. 17 US-MODERNATX, INC.-MOD-2023-718333:patient no. 27 US-MODERNATX, INC.-MOD-2023-718359:(Patient no-34 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718346:(Patient no- 14 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718319:patient no. 07 US-MODERNATX, INC.-MOD-2023-718335:patient no. 37 US-MODERNATX, INC.-MOD-2023-718363:(Patient no- 35 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718313:(Out of 42 patients case for patient 9) US-MODERNATX, INC.-MOD-2023-718317:(Out of 42 patients case for patient 29) US-MODERNATX, INC.-MOD-2023-718312:(Out of 42 patients case for patient 41) US-MODERNATX, INC.-MOD-2023-718339:(Patient no- 04 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718340:(Out of 42 patients case for patient 20) US-MODERNATX, INC.-MOD-2023-718342:(Out of 42 patients case for patient 40) US-MODERNATX, INC.-MOD-2023-718343:(Patient no- 13 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718341:(Out of 42 patients case for patient 30) US-MODERNATX, INC.-MOD-2023-718347:(Patient no- 24 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718332:(Out of 42 patients case for patient 10) US-MODERNATX, INC.-MOD-2023-718337:(Patient no-03 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718318:(Out of 42 patients case for patient 39) US-MODERNATX, INC.-MOD-2023-718331:(Out of 42 patients case for patient 8) US-MODERNATX, INC.-MOD-2023-718349:(Out of 42 patients case for patient 18) US-MODERNATX, INC.-MOD-2023-718356:(Patient no- 36 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718315:(Out of 42 patients case for patient 19) US-MODERNATX, INC.-MOD-2023-718344:(Patient no-23 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718310:(Out of 42 patients case for patient 31) US-MODERNATX, INC.-MOD-2023-718345:(Patient no-33 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718304:(Out of 42 patients case for patient 11) US-MODERNATX, INC.-MOD-2023-718309:(Out of 42 patients case for patient 21) US-MODERNATX, INC.-MOD-2023-718351:(Out of 42 patients case for patient 28) US-MODERNATX, INC.-MOD-2023-718352:(Out of 42 patients case for patient 38) US-MODERNATX, INC.-MOD-2023-718361:(Patient no- 25 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718358:(Patient no- 5 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718360:(Patient no- 15 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718367:(Patient no- 2 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718390:(Patient no- 12 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718391:(Patient no- 22 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718392:(Patient no- 32 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718394:(Patient no- 42 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718350:(Patient no- 6 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718353:(Patient no- 16 out of 42 patients) US-MODERNATX, INC.-MOD-2023-718355:(Patient no- 26 out of 42 patients)