Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 dose administered to patient after more than 1 temperature excursion; dose 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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 10:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:03 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 dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose 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 65.30 for dose administered on 14-Feb-2021 and 65.40 for dose administered on 20-Mar-2021. No concomitant medications were reported. Batch number 031L20A administered on 14-Feb-2021 underwent temperature excursion with temperature range of 32 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 13-Jan-2021. Batch number 031A21A administered on 20-Mar-2021 underwent temperature excursion with temperature range of 34-37 degrees Fahrenheit from 09:00 AM to 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).