Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: undergone several temperature excursions and was administered prior to the viability of the vaccine being known; The max temperature reached was 10.9F; poor quality vaccine administered; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (undergone several temperature excursions and was administered prior to the viability of the vaccine being known), PRODUCT STORAGE ERROR (The max temperature reached was 10.9F), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (undergone several temperature excursions and was administered prior to the viability of the vaccine being known), PRODUCT STORAGE ERROR (The max temperature reached was 10.9F), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (undergone several temperature excursions and was administered prior to the viability of the vaccine being known), PRODUCT STORAGE ERROR (The max temperature reached was 10.9F), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (undergone several temperature excursions and was administered prior to the viability of the vaccine being known), PRODUCT STORAGE ERROR (The max temperature reached was 10.9F) and POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered).    Concomitant medication was not reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Moderna product was stored in the freezer and experienced multiple warm excursions starting on 3/15/2023. Temperature data shows the vaccine was above 5F for a total of approximately 57 hours.  Two boxes of Moderna (Bivalent vaccine) Lot 066H22A was delivered on 3/15/2023 and placed in the freezer upon delivery. One box with Lot was relocated to fridge on 4/21/2023 and did not experience further excursions. This was an opened box with 9 vials. One vial was used on 4/21/2023. There was one full box impacted in the freezer that has not been relocated.   Treatment drug was not reported.