Age: 82.0
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 an 82-year-old male 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 2:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 1:53 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 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). 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 82.03 years for dose administered on 03-Mar-2021 and 82.11 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 at 10:00 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 traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).