Age: 39.0
Sex: M
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; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; 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) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 14M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 02-Mar-2021 at 4:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 4:27 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). 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 (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 53.95 for dose administered on 02-Mar-2021  No concomitant medications were reported. Batch number 008C21A underwent temperature excursion on 27-Feb-2021 with temperature 33 degrees Fahrenheit from 09:00 AM and 35 degrees Fahrenheit from 11:00 AM-02:00 PM  and 35 degrees Fahrenheit from 03:00 PM-04:00 PM and 35 degrees Fahrenheit from 05:00 PM. This vial was moved to fridge on 27-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021 . Product moved to clinic on 24-Feb-2021.  Batch number 008C21A underwent temperature excursion on 28-Feb-2021 with temperature 27 degrees Fahrenheit from 09:00 AM and 26 degrees Fahrenheit from 01:00 PM. This vial was moved to fridge on 27-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021 . Product moved to clinic on 24-Feb-2021. Batch number 008C21A underwent temperature excursion on 02-Mar-2021 with temperature 27 degrees Fahrenheit from 09:00 AM and 29 degrees Fahrenheit from 10:00 AM and 32 degrees Fahrenheit from 11:00 AM  and 33 degrees Fahrenheit from 12:00 PM and 35 degrees Fahrenheit from 02:00 PM  and 36 degrees Fahrenheit from 03:00 PM. This vial was moved to fridge on 02-Mar-2021 and beyond use date for the vial was reported as 26-Mar-2021 . Product moved to clinic on 24-Feb-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 temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).