Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Product storage error, underwent temperature excursion started on 21Feb2023; 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 (Product storage error, underwent temperature excursion started on 21Feb2023), 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 (Product storage error, underwent temperature excursion started on 21Feb2023), 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 (Product storage error, underwent temperature excursion started on 21Feb2023), 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 (Product storage error, underwent temperature excursion started on 21Feb2023) and POOR QUALITY PRODUCT ADMINISTERED (They were to be used within 24 hours but administered to 17 patients on unknown dates).    No concomitant medication were reported.  Dosage text for suspect product was reported as unknown. 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. Consent for safety follow up provided via email. LOT 214K22A expiration Date 29Aug2023 Excursion Timeframe was reported on 21Feb2023, Max 8.60C for 10 hours and 57 minutes 22Feb2023. Max 8.5 C Duration: 24 hours 23Feb2023. 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 8th of 17 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713728, US-MODERNATX, INC.-MOD-2023-713748, US-MODERNATX, INC.-MOD-2023-713760, US-MODERNATX, INC.-MOD-2023-713747, US-MODERNATX, INC.-MOD-2023-713742, 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-2023-713757, US-MODERNATX, INC.-MOD-2023-713758, US-MODERNATX, INC.-MOD-2023-713759, US-MODERNATX, INC.-MOD-2023-713761, US-MODERNATX, INC.-MOD-2023-713762 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713728:Patient 1 US-MODERNATX, INC.-MOD-2023-713760: US-MODERNATX, INC.-MOD-2023-713747: US-MODERNATX, INC.-MOD-2023-713748: US-MODERNATX, INC.-MOD-2023-713742: 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-2023-713757: US-MODERNATX, INC.-MOD-2023-713758: US-MODERNATX, INC.-MOD-2023-713759: US-MODERNATX, INC.-MOD-2023-713761: US-MODERNATX, INC.-MOD-2023-713762: