Age: 76.0
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 7-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021 at 9:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Nov-2021 at 12:52 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced 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). 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 the patient was reported as 77.54 for the vaccination date 03-Nov-2021 and 76.84 for the vaccination date 17-Feb-2021. Concomitant products were not provided. Batch number 035C21A underwent temperature excursion on 03-Nov-2021, Excursion time was 10 AM, temp was 35 , total doses given for the day was 117, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021, 6vial was moved to clinic. Vaccine BUD date was 05-Nov-2021. Batch number 022M20A underwent temperature excursion on 17-Feb-2021, Excursion time was 8AM, temp was 20 , total doses given for the day was 62, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 17-Feb-2021, 1 vial was moved to clinic. Vaccine BUD date was 10-Mar-2021. Batch number 022M20A underwent temperature excursion on 17-Feb-2021, Excursion time was 9AM, temp was 22 , total doses given for the day was 62, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021, 5 vial was moved to clinic. Vaccine BUD date was 13-Mar-2021. Batch number 035C21A  Vial was stored on cooler 1, on 03-Nov-2021, Excursion duration at 8 AM:36,  9 AM:36, 10 AM: 36, 11 AM:35, 12 AM:36, 1PM : 37, 2 PM : 36, 3 PM: 36, 4 PM: 37 and 5 PM : 42. 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. Vials only punctured right before administration  Treatment medications were not reported.