Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 36-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 28-Feb-2021 at 3:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 3:01 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 (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) 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 36.35 for dose administered on 28-Feb-2021 and 36.43 for dose administered on 28-Mar-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature of 33 degrees Fahrenheit at 09:00 AM, 35 degrees Fahrenheit from 11:00 AM to 02:00 PM, 34 degrees Fahrenheit from 03:00 PM to 04:00 PM, 35 degrees Fahrenheit at 05:00 PM and underwent temperature excursion on 28-Feb-2021 with temperature of 27 degrees Fahrenheit on 09:00 AM and 26 degrees Fahrenheit on 01:00 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 27-Feb-2021.   Batch number 019B21A underwent the temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 9:00 AM to 10:00 AM and underwent temperature excursion on28-Mar-2021 with temperature of 35 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-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 traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).