Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 3:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 3:17 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's age was reported as 66.07 years for dose administered on 03-Mar-2021 and 66.15 years for dose administered on 31-Mar-2021.   No concomitant medications were reported.  Batch Number 014M20A, vials sent to clinic were 20. Vial moved to fridge on 24-Feb-2021 and beyond use date for these vials was reported as 26-Mar-2021. Vial was moved to clinic on 03-Mar-2021. On 03-Mar-2021, same batch number vial was administered which underwent temperature excursion with temperature of 51 degrees Fahrenheit at 09:00 am, 34 degrees Fahrenheit from 10:00 am and 35 degrees Fahrenheit at 01:00 pm.  On 03-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.  Batch Number 030B21A, vials sent to clinic were 14. Vial moved to fridge on 30-Mar-2021 and beyond use date for these vials was reported as 29-Apr-2021. Vial was moved to clinic on 31-Mar-2021. On 31-Mar-2021, same batch number vial was administered which underwent temperature excursion with temperature of 32 degrees Fahrenheit at 08:00 am and 09:00 am.  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.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of 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. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).