Age: 74.0
Sex: M
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 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021 at 1:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 1:40 PM, 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's age was reported as 70.10 years for dose administered on 27-Feb-2021 and 70.17 years for dose administered on 27-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 27-Feb-2021. On 27-Feb-2021, same batch number vial was administered which underwent temperature excursion with temperature of 33 degrees Fahrenheit at 09:00 am, 35 degrees Fahrenheit from 11:00 am till 02:00 pm, 34 degrees Fahrenheit from 03:00 pm till 04:00 pm and 35 degrees Fahrenheit at 05:00 pm.  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.  Batch Number 019B21A, vials sent to clinic were 20. Vial moved to fridge on 23-Mar-2021 and beyond use date for these vials was reported as 22-Apr-2021. Vial was moved to clinic on 27-Mar-2021. On 27-Mar-2021, same batch number vial was administered which underwent temperature excursion with temperature of 35 degrees Fahrenheit at 08:00 am and 09:00 am.  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.