Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 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.; Vaccine administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of 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.) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 9:13 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:25 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced 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, 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.) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 50.66 for dose administered on 02-Mar-2021 and 50.74 for dose administered on 30-Mar-2021.  No concomitant medications were reported.  On 24-Feb-2021, The vial with batch number 014M20A was moved to the fridge. On 02-Mar-2021, Product moved to clinic, at 09:00 A.M., the temperature recorded was 27 degree fahrenheit, at 10:00 A.M., the temperature recorded was 29 degree fahrenheit, At 11:00 A.M., the temperature recorded was 32 degree fahrenheit, at 12 P.M., the temperature recorded was 33 degree fahrenheit, at 2 P.M., the temperature recorded was 35 degree fahrenheit, at 3 P.M., the temperature recorded was 36 degree fahrenheit and beyond use date was reported as 26-Mar-2021.  On 23-Mar-2021, The vial with batch number 019B21A was initially moved to the fridge. On 30-Mar-2021, Product moved to clinic, at 09:00 A.M., the temperature recorded was 33 degree fahrenheit and beyond use date was reported as 22-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. 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.