Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine 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 (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 4:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 4:09 PM, 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 (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered 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 reported as 68.69 on 31-Mar-2021 and 68.61 on 3-Mar-2021. Concomitant products were not provided. On 3-Mar-2021, Excursion time was at 09 AM temperature was 51, at 10 AM temperature was 34 and at 1 PM temperature was 35, total doses given for the day was 200, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 3-Mar-2021. 20 vials were sent to clinic respectively. Vaccine BUD date was 26-Mar-2021. On 3-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM: 35, 2 PM: 36, 3 PM: 36, and 4 PM: 36. On 31-Mar-2021, Excursion time was at 08 AM temperature was 32 and at 9 AM temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021 and 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 4 and 14 vials were sent to clinic respectively. Vaccine BUD date was 22-Apr-2021 and 29-Apr-2021 respectively. On 31-Mar-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: 46, 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 or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.