Age: 67.0
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 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A, 030B21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 3:44 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 3:18 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Oct-2021 at 9:46 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In 2021, 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.28 for dose administered on 03-MAR-2021, 67.36 for dose administered on 31 -MAR-2021 and 67.93 for dose administered on 27-OCT-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion 03-MAR-2021 with temperature 51 degrees Fahrenheit at 09:00 AM, 34 degrees Fahrenheit at 10:00 AM and 35 degrees Fahrenheit at 1:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-MAR-2021. Batch number 030B21A underwent temperature excursion on 31 -MAR-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 30-MAR-2022 and beyond use date for the vial was reported as 29-APR -2021. Product moved to clinic on 31-MAR-2021.  Batch number 035C21A underwent temperature excursion on 27-OCT-2021 with temperature 29 degrees Fahrenheit at 09:00 AM and 32 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 29-SEP-2021 and 05-OCT-2021 and beyond use date for the vial was reported as 29-OCT-2021 and 04-NOV-2021. Product moved to clinic on 27-OCT-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 traceable temperature monitor at every hour.  No treatment medications were reported.