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. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 10:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 10:02 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.   The age of patient was provided as 42.61 and 42.69.  Concomitant medication of the patient was not reported.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature of 33 degrees Fahrenheit at 09:00 AM, 35 degrees Fahrenheit at 11:00 AM, 35 degrees Fahrenheit at 12:00 PM, 35 degrees Fahrenheit at 01:00 PM, 35 degrees Fahrenheit at 02:00 PM, 34 degrees Fahrenheit at 03:00 PM, 34 degrees Fahrenheit at 04:00 PM and 35 degrees Fahrenheit at 05:00 PM. These vials were moved to fridge on 24-Feb-2021 and beyond use date for the vials was reported as 26-Mar-2021. The vaccines moved to clinic on 27-Feb-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature of 35 degrees Fahrenheit at 09:00 AM and 35 degrees Fahrenheit at 10:00 AM. These vials were moved to fridge on 23-Mar-2021 and beyond use date for the vials was reported as 22-Apr-2021. The vaccines moved to clinic on 27-Mar-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).