Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses 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 (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 65-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 1:31 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 1:46 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 (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses 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 Route), the reporter did not provide any causality assessments.   The patient's age at vaccination provided on 03-Mar-2021 at 01:31 PM was reported as 65.64. The patient's age at vaccination provided on 31-Mar-2021 at 01:46 PM was reported as 65.72.  Concomitant products were not provided.  On 03-Mar-2021, Temperature Excursion at 9 AM, 10 AM and 1 PM, the temperature was 51, 34 and 35 degrees Fahrenheit respectively. 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 03-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 31-Mar-2021, Temperature Excursion at 9 AM, the temperature was 32 degrees Fahrenheit, Condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic on respective dates. Vaccine BUD date was 29-Apr-2021.  Vial was stored in cooler 1, on 03-Mar-2021, Excursion duration at 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM: 35, 2 PM : 36, 3 PM: 36 and 4 PM: 36. Vial was stored in cooler 1, on 31-Mar-2021, Excursion duration at 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 24, 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 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 F.  Treatment medications were not reported.