Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; dose 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 (dose 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 9:27 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 9:02 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose 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). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered 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.   The age of patient was provided as 47.53 at vaccination on 14-Feb-2021 and 45.63 at vaccination on 21-Mar-2021.  No concomitant medications were reported.  The vial with batch number 031L20A was initially stored in the fridge on 09-Feb-2021, moved to clinic on 12-Feb-2021 and proposed beyond use date was 10-Mar-2021. On 12-Feb-2021, at 09:00 A.M., the temperature recorded was 29 degree Fahrenheit, at 10:00 A.M., the temperature recorded was 35 degree Fahrenheit and at 11:00 A.M., the temperature recorded was 35 degree Fahrenheit that has been reached by the vial. On 13-Feb-2021, at 09:00 A.M., the temperature recorded was 32 degree Fahrenheit, that has been reached by the vial. On 14-Feb-2021, from 09:00 A.M to 03:00 P.M, the temperature recorded was 32 and 35 degree Fahrenheit, that has been reached by the vial.  The vial with batch number 003B21A was initially stored in the fridge on 16-Mar-2021, moved to clinic on 21-Mar-2021 and proposed beyond use date was 15-Apr-2021. On 21-Mar-2021, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit, at 10:00 A.M., the temperature recorded was 32 degree Fahrenheit and at 11:00 A.M., the temperature recorded was 34 degree Fahrenheit that has been reached by the vial.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time 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 traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).