Age: 55.0
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 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 1:32 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 1:14 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.   No concomitant medication was reported.  Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature 32 to 35 degrees Fahrenheit at 09 AM to 03 PM. Total 162 doses were given for the day. Vials were not frozen. This vial was moved to fridge on 09-Feb-2021 and BUD date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021. 30 vials were sent to clinic.  Batch number 003B21A underwent temperature excursion on 21-Mar-2021 with temperature 34 degrees Fahrenheit at 09 AM, 32 degrees Fahrenheit at 10 AM and 34 degrees Fahrenheit at 11 AM. Total 94 doses were given for the day. Vials were not frozen. This vial was moved to fridge on 16-Mar-2021 and BUD date for the vial was reported as 15-Apr-2021. Product moved to clinic on 21-Mar-2021. 10 vials were sent to clinic.  For batch no. 003B21A, on 21-Mar-2021, the vial was stored in cooler 1, the temperature at 09 am was 34, at 10 am was 32 and at 11 am was 34.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).