Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F; Doses administered 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 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 2:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 2:23 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 68.99. No concomitant medication was reported by reporter. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 8:00 Am and 9:00 AM . This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time 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 by using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).