Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion; Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) in an 84-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 1:04 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 1:18 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Mar-2021 at 1:04 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 84.72 and 84.80.  Concomitant products were not provided.  For Batch number 014M20A On 02-Mar-2021, Excursion time were at 09 AM was 27, at 10PM, temp was 29, at 11 AM, temp was 32, at 12PM, temp was 33, at 02PM, temp was 35, at 03 PM, temp was 36, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vial was moved to clinic. Vaccine BUD date was 26-Mar-2021.  For Batch 019B21A On 30-Mar-2021, Excursion time were 9 AM, temp was 33 , total doses given for the day was 173, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 3 vial was moved to clinic. Vaccine BUD date was 22-Apr-2021.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Temperature recordings were taken by using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).