Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 52-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 02-Mar-2021 at 1:33 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 1:27 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 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.     Concomitant products were not provided.  On 30-Mar-2021, three vials were moved to clinic of batch number 019B21A. On 23-Mar-2021, the vaccines of same batch were moved to fridge, sent to clinic on 30-Mar-2021 and proposed beyond use date was 22-Apr-2021 for batch number 019B21A.  For batch number: 019B21A On 30-Mar-2021, at 09:00 A.M., the temperature recorded was 33 Fahrenheit that has been reached by the vial.  On 02-Mar-2021, 16 vials were moved to clinic of batch number 014M20A. On 24-Feb-2021, the vaccines of same batch were moved to fridge and proposed beyond use date was 26-Mar-2021 for batch number 014M20A. Vaccine got moved to clinic on 03-Mar-2021.  For batch number: 014M20A, on 02-Mar-2021, at 09:00 A.M., the temperature recorded was 27 Fahrenheit, at 10:00 A.M., the temperature recorded was 29 Fahrenheit, at 11:00 A.M. the temperature recorded was 32 Fahrenheit, at 12:00 P.M. the temperature recorded was 33 Fahrenheit and 2:00 P.M., the temperature recorded was 35 Fahrenheit, and at 3:00 P.M., the temperature recorded was 36 Fahrenheit.  The vials were only punctured right before administration and both the doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 Fahrenheit.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.