Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 39-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 3:33 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 3:22 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) 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 39.56 for dose administered on 14-Feb-2021 and 39.66 for dose administered on 21-Mar-2021. No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 12-Feb-2021 with temperature of 29 degrees Fahrenheit on 09:00 AM and 34 degrees Fahrenheit from 10:00 AM to 11:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 12-Feb-2021. Batch number 031L20A underwent the temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit on 9 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021. Batch number 031L20A underwent the temperature excursion on 14-Feb-2021 with temperature 32 degrees Fahrenheit from 9:00 AM to 11:00 AM and 35 degrees Fahrenheit from 2:00 PM to 03:00 PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021. Batch number 003B21A underwent temperature excursion on 21-Mar-2021 with temperature 34 degrees Fahrenheit on 09:00 AM, 32 degrees Fahrenheit on 10:00 AM and 34 degrees Fahrenheit on 11:00 AM. This vial was moved to fridge on 16-Mar-2021 and beyond use date for the vial was reported as 15-Apr-2021. Product moved to clinic on 21-Mar-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.  No treatment was reported.   This case was linked to MOD-2022-566976 (Patient Link).