Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 66.31. Concomitant products were not provided. On 03-Mar-2021, Excursion time was 09 AM and 10 AM, and 1pm with temperature as 51, 34 and 35 respectively. Total doses given for the day was 200 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9 AM vaccine was moved to fridge on 09-mar-2021 and. Vial was moved to clinic on 20-mar-2021. 20 vials from 9 AM and 4 vials from 10 AM were sent to clinic. Vaccine BUD date was 26-mar-2021 for 9AM,10 AM and 1PM respectively. On 03-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 51, 10 AM: 34 11 AM: 44, 12 AM: 46, 1PM: 35, 2 PM: 36, 3 PM: 36, and 4 PM: 36. and 5 PM: 45. On 31-Mar-2021, Excursion time was 08 AM and 9 AM, and 1pm with temperature as 32, and 32 respectively. Total doses given for the day was 199 for 8AM vials. Condition of vaccine prior to administration was not frozen. 8 AM vaccine was moved to fridge on 23-mar-2021 and 9 AM was moved on 30-mar-2021. Vial was moved to clinic on 31-Apr-2021 vials from 9 AM and 8 vials from were sent to clinic. Vaccine BUD date was 31-Apr-2021 for 9 AM 22-apr-2021 and 9pm 29-apr-2022 for 10AM respectively. On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM: 4 6, 3 PM: 46, 4 PM: 44 and 5 PM: 44. 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. 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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour.