Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 2:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 2:40 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) 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 45.43 years.  Concomitant products were not provided.  Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27 to 36 degrees Fahrenheit from 09:00 AM to 03:00 PM. On 24-Feb-2021, the vaccine with batch number 014M20A was moved to fridge. On 02-Mar-2021, 16 vials were moved to the clinic. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 26-Mar-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, 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 medications were not reported.  This case was linked to MOD-2022-566976 (Patient Link).