Age: 69.0
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 6-decade-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A, 019B21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 10:41 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 10:51 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Nov-2021 at 12:56 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 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.   Age of patient was reported as 68.91 for dose administered on 02-MAR-2021, 68.98 for dose administered on 30-MAR-2021 and 69.58 for dose administered on 03-NOV-2021  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion 02-MAR-2021 with temperature 27 degrees Fahrenheit at 09:00 AM, 29 degrees Fahrenheit at 10.00 AM, 32 degrees Fahrenheit at 11.00 AM, 33 degrees Fahrenheit at 12.00 PM, 35 degrees Fahrenheit at 2.00 PM and 36 degrees Fahrenheit at 3.00 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 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-2022 and beyond use date for the vial was reported as 22-APR -2021. Product moved to clinic on 30-MAR-2021  Batch number 035C21A underwent temperature excursion on 03-NOV-2021 with temperature 35 degrees at 10:00 AM. This vial was moved to fridge on 05-OCT-2021 and beyond use date for the vial was reported as 05-NOV-2021. Product moved to clinic on 03-NOV-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 brand traceable temperature monitor at every hour.  No treatment medications were reported.