Age: 66.0
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 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 11:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 10:32 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced 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). 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.   No Concomitant product use was reported.  It was reported that unknown number of patients were 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 time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 14-Feb-2021, the excursion time on initial supply was 09 am, temperature was 32, At 10:00 AM temperature was 32, at 11 AM temperature was 32, at 2PM temperature was 35, at 3PM temperature was 35. Total 162 doses were administered for that day, condition of vaccine prior to vaccination was not frozen. Vaccine moved to fridge on 09-Feb-2021 and moved to clinic on 13-Jan-2021. 30 vials were moved to the clinic. Vaccine BUD date was 10-Mar-2021. The vaccine was administered on 14-Feb-2021 and poor quality vaccine was administered, and the vaccine undergone product temperature excursion.  On 21-Mar-2021, the excursion time on initial supply was 9am and the temperature was 34, At 10:00 AM temperature was 32, at 11 AM temperature was 34, total 94 doses were administered for that day, vaccine was not frozen prior to administration. Vaccine moved to fridge on 16-Mar-2021 and moved to clinic on 21-Mar-2021. 10 vials were moved to the clinic. Vaccine BUD date was 15-Apr-2021. The vaccine was administered on 21-Mar-2021 and poor quality vaccine was administered, and the vaccine undergone product temperature excursion.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.