Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered 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 after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 12:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 1:00 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (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 reported as 30.97 on 14-Feb-2021 and 31.06 on 21-Mar-2021.  Concomitant products were not provided.  Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature of 32 degrees Fahrenheit at 09:00 AM, 32 degrees Fahrenheit at 10:00 AM, 32 degrees Fahrenheit at 11:00 AM, 35 degrees Fahrenheit at 02:00 PM and 35 degrees Fahrenheit at 03:00 PM. These vials were moved to fridge on 09-Feb-2021.The vaccines moved to clinic on 13-Jan-2021. BUD date for the vials was reported as 10-Mar-2021.  Batch number 003B21A underwent temperature excursion on 21-Mar-2021 with temperature of 34, 32 and 34 degrees Fahrenheit at 09:00 AM, 10:00 AM, 11:00 AM. These vials were moved to fridge on 16-Mar-2021. Product moved to clinic on 21-Mar-2021. Vaccine BUD date was 15-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 traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021.   This case was linked to MOD-2022-566976 (Patient Link).