Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 10:59 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 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 64.44 and 64.52 for dose 1 and 2 respectively.  Concomitant products were not provided.  On 24-Feb-2021, vaccines with batch number 014M20A were moved to the fridge. On 03-Mar-2021, vials were moved to clinic. On the same day between 09 AM to 05 PM, vials underwent temperature excursion with temperature ranging from 33 to 35 degrees Fahrenheit. On 28-Feb-2021 at 09 AM and 01 PM, 20 vials underwent temperature excursion with temperature 27 to 26 degrees Fahrenheit respectively. On 02-Mar-2021 between 09 AM to 11 AM, 16 vials underwent temperature excursion with temperature ranging from 27 to 32 degrees Fahrenheit. On 03-Mar-2021 at 09 AM and 10 AM, 20 vials underwent temperature excursion with temperature 51 to 34 degrees Fahrenheit respectively. The vaccine beyond use date was reported as 26-Mar-2021.  On 30-Mar-2021, vaccines with batch number 030B21A were moved to the fridge. On 31-Mar-2021, 14 vials were moved to clinic. On the same day between 08 AM to 09 PM, vials underwent temperature excursion with temperature of 32 degrees Fahrenheit. The vaccine beyond use date was reported as 29-Apr-2021.  The condition of vaccine prior to vaccination was not frozen. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).