Age: 82.0
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 POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 11:22 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 11:28 AM, received second 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 (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 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 82.63 for dose administered on 28-Feb-2021 and 82.71 for dose administered on 28-Mar-2021.  Concomitant products were not provided.   On 24-Feb-2021, vaccines with batch number 014M20A were moved to the fridge. On 27-Feb-2021, 20 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, vials underwent temperature excursion with temperature 27 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 26-Mar-2021.   On 23-Mar-2021, the vaccine with batch number 019B21A was moved to fridge. On 27-Mar-2021, 20 vials were moved to the clinic. On the same day between 09 AM to 10 AM, vials underwent temperature excursion with temperature of 35 degrees Fahrenheit. On 28-Mar-2021 at 10 AM, 15 vials underwent temperature excursion with temperature of 35 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 22-Apr-2021.   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 Fisherbrand 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).