Age: 69.0
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 PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and 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) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021 at 11:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Nov-2021 at 3:34 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In 2021, 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, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and 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) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  On 20-Mar-2021, for vial with batch number 031A21A, excursion time was reported at 09 A.M and 10 A.M with temperature as 34 and 30 degrees Fahrenheit respectively, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD (beyond use date) was 08-Apr-2021.  On 03-Nov-2021, for vial with batch number 035C21A, excursion time was reported at 10 A.M with temperature as 35 degrees Fahrenheit respectively, total doses given for the day was 117 , condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-May-2021, vial was moved to clinic on 03-Nov-2021. 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was 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 Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).