Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered to patient after more than 1 temperature excursion; Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 12:17 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-arterial) .5 milliliter. On 20-Mar-2021 at 12:01 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-arterial) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-arterial), the reporter did not provide any causality assessments.   Age of patient was reported as 46.75 for dose administered on 13-Feb-2021 and 46.85 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  On 13-Jan-2021, The vaccine with batch number 031L20A was moved to clinic. On 09-Feb-2021, Vial was moved to fridge and beyond use date for the vial was reported as 10-Feb-2021. On 13-Feb-2021 at 09:00 am, Temperature excursion reported as 32 degrees fahrenheit.  On 09-Mar-2021, The vaccine with batch number 031A21A was moved to fridge. On 20-Mar-2021, Product moved to clinic and temperature excursion reported as of 34 and 37 degrees fahrenheit at 09:00 AM and 10:00 AM. Beyond use date for the vial was reported as 08-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree fahrenheit. Temperature recordings were taken using a fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.