Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursions 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 excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 11:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 10:41 AM, 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 (Doses administered after more than 1 temperature excursions 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 excursions 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 excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursions 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.   Patient age was reported age 71.43 during 02-Mar-2021 administration and 71.50 during 30-Mar-2021 administration.  No concomitant medication was reported by reporter.  Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27, 29, 32, 33, 35 and 36 degrees Fahrenheit at 09:00 AM, 10:00 AM, 11:00 AM, 12:00 PM, 02:00 PM and 03:00 PM respectively. This vial was moved to fridge on 24-Feb-2021 and BUD date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021.  Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and BUD date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021.  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.  After administration, the vials were returned to the freezer/refrigerator, or maintained at room temperature.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).