Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 64-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 02-Mar-2021 at 9:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:40 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F). 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 64.60 years on  30-Mar-2021 and 64.52 years on 02-Mar-2021.  On 02-Mar-2021, Excursion time was 9 AM, temp was 37 ,total doses given for the day was 173, Excursion time was 10 AM, temp was 29 ,Excursion time was 11 AM, temp was 32,  Excursion time was 12 AM, temp was 32,Excursion time was 02 PM, temp was 35, Excursion time was 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.  Vial was stored on cooler 1, Excursion duration At 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 AM: 33, 1PM : 36, 2 PM : 35, 3 PM: 36, 4 PM: 37 and 5PM: 37. On 30-Mar-2021, Excursion time was 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. Vial was stored on cooler 1 , Excursion duration At 8AM: 38 9 AM: 33, 10 AM: 36, 11 AM: 36, 12 AM: 40, 1PM : 40, 2 PM : 39, 3 PM: 38, 4 PM: 40 and 5PM: 40.  Concomitant products were not provided.  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.