Age: 28.0
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; 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 28-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 02-Mar-2021 at 4:26 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 4:35 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, 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 28.64  for dose administered on 02-Mar-2021 and 28.71 for dose administered on 30-Mar-2021 Concomitant products were not provided. On 24-Feb-2021, the vaccine with batch number 014M20A was moved to fridge. On 27-Feb-2021,20 vials were moved to the clinic.on 27-Feb-2021 at 9:00 to 17:00, vials underwent temperature excursion with temperature of 22 to 35 degrees Fahrenheit.The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 26-Mar-2021. For batch number 014M20A, 199 doses given for the day.Temperature excursion for For batch number 014M20A was reported for cooler 1 of the device On 23-Mar-2021, the vaccine with batch number 019B21A was moved to fridge. On 27-Mar-2021,15 vials were moved to the clinic. On 28-Mar-2021 at 10AM, vials underwent temperature excursion with temperature 35 degrees Fahrenheit.On 23-Mar-2021,the vaccine with batch number 019B21A was moved to fridge. On 27-Mar-2021,  15  vials were moved to the clinic. On 27-Mar-2021 at 9:00 AM to 10AM, vials underwent temperature excursion with temperature 35 degrees Fahrenheit.The condition of vaccine prior to vaccination was not frozen.The vaccine beyond use date was reported as 22-Apr-2021, For batch number 019B21A, 195 doses given for the day.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 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,data logger registered 34 or 35 degree Fahrenheit