Age: 46.0
Sex: M
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 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 11:34 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:49 AM, received 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 46.12 for dose administered on 13-Feb-2021 and 46.21 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 12-Feb-2021 with temperature 29 degrees Fahrenheit on 9 AM, 35 degrees Fahrenheit from 10 AM to 11 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 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit on 09:00 AM and 37 degrees Fahrenheit on 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-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 medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).