Age: 38.0
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 38-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 27-Feb-2021 at 9:29 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:04 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Feb-2021 at 9:29 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 38.10 for dose administered on 27-Feb-2021 and 38.18 for dose administered 27-Mar-2021.  Concomitant medication information was not provided by the reporter.  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 vials underwent temperature excursion with temperature of 33, 34 and 35 degrees Fahrenheit from 09:00 AM to 01:00 PM. 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 27-Mar-2021 vials underwent temperature excursion with temperature of 35 degrees Fahrenheit from 09:00 AM to 10:00 AM. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 22-Apr-2021.  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 each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degrees Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).