Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: 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; 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 (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021 at 11:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 11:56 AM, 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 (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). 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 (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 86.29 for dose administered on 12-Feb-2021 at 11:56 AM.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 12-Feb-2021 with temperature 29 degrees Fahrenheit at 09:00 AM and 35 degrees Fahrenheit at 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. Vial was in cooler storage during high-pace COVID-19 vaccination clinic 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).