Age: 20.0
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 20-year-old male 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 27-Feb-2021 at 11:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 11:28 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Feb-2021 at 11:57 AM, 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 20.97 for dose administered on 27-FEB-2021 and 21.06 for dose administered on 30-Mar-2021.  Concomitant medication was not reported.  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.  On 23-Mar-2021, the vaccine with batch number 019B21A was moved to fridge. On 27-Mar-2021, 15 vials and on 27-Mar-2021, 20 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. On 28-Mar-2021 at 10AM, vials underwent temperature excursion with temperature 35 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. On 29-Mar-2021, 20 vials were moved to the clinic. On 29-Mar-2021 at 10AM, vials underwent temperature excursion with temperature 35 degrees Fahrenheit. On 30-Mar-2021, 03 vials were moved to the clinic. On 30-Mar-2021 at 9AM, vials underwent temperature excursion with temperature 33 degrees Fahrenheit. The vaccine beyond use date was reported as 22-Apr-2021.  It was reported that, 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 information was not provided.