Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccine which underwent temperature excursion started on 21-Feb-2023; Bivalent Vaccine underwent temperature excursion started on 21Feb2023; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion started on 21-Feb-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent Vaccine underwent temperature excursion started on 21Feb2023) 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 (Patient was administered with vaccine which underwent temperature excursion started on 21-Feb-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent Vaccine underwent temperature excursion started on 21Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion started on 21-Feb-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent Vaccine underwent temperature excursion started on 21Feb2023) 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 (Patient was administered with vaccine which underwent temperature excursion started on 21-Feb-2023) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent Vaccine underwent temperature excursion started on 21Feb2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that the bivalent vaccine for 6 months to 5 years, underwent temperature excursion started on 21-Feb-2023 which was to be used within 24 hours but was administered to the patient on unknown date. The excursion timeframe was reported as on 21-Feb-2023, maximum temperature of 8.60C for 10 hours and 57 minutes, on 22-Feb-2023, maximum temperature of 8.5 C for 24 hours and on 23-Feb-2023, maximum temperature of 8.5 C and minimum of 7.4 C for 17 hours and 56 minutes.  No treatment medications was reported.  This case contains information for the 9th  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 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713728: US-MODERNATX, INC.-MOD-2023-713757: US-MODERNATX, INC.-MOD-2023-713760: US-MODERNATX, INC.-MOD-2023-713748: US-MODERNATX, INC.-MOD-2023-713756: US-MODERNATX, INC.-MOD-2023-713747: US-MODERNATX, INC.-MOD-2023-713751: US-MODERNATX, INC.-MOD-2023-713742:Patient no 9