Age: 42.0
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 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 11:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 12:11 PM, 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.   The age of patient was provided as 42.32 for 27-Feb-2021 vaccination. The age of patient was provided as 42.40 for 27-Mar-2021 vaccination.  Concomitant medication was not provided.  On 27-Feb-2021, Excursion time was 9 AM, 11AM, 12AM, 1PM, 2PM, 3PM, 4PM, 5PM, with temperature as 33, 35, 35, 35, 35, 35,34, 34 and 35 respectively. Total doses given for the day was 199 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9AM vaccine was moved to fridge on 24-Feb-2021 and 9 AM. 20 Vial was moved to clinic on 27-feb-2021 vials were sent to clinic. Vaccine BUD date was 26-mar-2021 for 9 AM respectively. On 27-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35.  On 27-Mar-2021, Excursion time was 9 AM, 10 AM with temperature as 35 and 35 respectively. Total doses given for the day was 195 for 9AM vials. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 23-Mar-2021. Vial was moved to clinic on 27-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. On 27-Mar-2021, no hourly temperature recordings available.  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 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 temperature data logger registered 34 or 35 degree F.  Treatment information was not reported.