Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021 at 9:49 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:44 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (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. On 27-Feb-2021 Age of patient was reported as 25.75 and on 27-Mar-2021 Age of patient was reported as 25.83. No concomitant medications were reported. On 27-Feb-2021 at 09:00 A.M., the temperature recorded was 33 degree Fahrenheit, at 11:00 A.M., the temperature recorded was 35 degree Fahrenheit, At 12:00 P.M., the temperature recorded was 35 degree Fahrenheit, at 01:00 P.M., the temperature recorded was 35 degree Fahrenheit, at 02:00 P.M., the temperature recorded was 35 degree Fahrenheit, at 03:00 P.M., the temperature recorded was 34 degree Fahrenheit, at 04:00 P.M., the temperature recorded was 34 degree Fahrenheit, at 05:00 P.M., the temperature recorded was 35 degree Fahrenheit and respectively the vial was moved to the fridge 24-Feb-2021 and beyond use date was 26-Mar-2021 Product moved to clinic on 27-Feb-2021. On 27-Mar-2021 at 09:00 A.M., the temperature recorded was 35 degree Fahrenheit and on 10:00 A.M., the temperature recorded was 35 degree Fahrenheit and vial was initially moved to the fridge on 23-Mar-2021 and beyond use date was 22-Apr-2021.Product moved to clinic on 27-Mar-2021. Vial was stored on cooler 1, on 27-Feb-2021, Excursion duration At 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35. 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 Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported.