Age: 58.0
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 58-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 3:32 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:51 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Mar-2021 at 3:32 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). 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). 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.   The age of patient was provided as 58.77 at administration of 02-Mar-2021 and 58.85 at administration of 30-Mar-2021.  Concomitant products were not provided.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  On 02-Mar-2021, vial was stored on cooler 1, Excursion duration At 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 AM: 33, 1PM: 36, 2 PM : 35, 3 PM: 36, 4 PM: 37, 5PM: 37.  On 02-Mar-2021, at 09:00 A.M., the temperature recorded was 27 degree Fahrenheit, total doses given for the day was 177, at 10:00 A.M, the temperature recorded was 29 degree Fahrenheit , at 11:00 A.M., the temperature recorded was 32 degree Fahrenheit, at 12:00 P.M., the temperature recorded was 33 degree Fahrenheit, at 02:00 P.M., the temperature recorded was 35 degree Fahrenheit, at 03:00 P.M., the temperature recorded was 36 degree Fahrenheit and condition of vaccine prior to administration was not frozen, vial was initially moved to the fridge on 24-Feb-2021 and vial was moved to clinic on 02-Mar-2021,16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 30-Mar-2021, Excursion time was 09 AM, temperature were 33 respectively and total doses given for the day was 173, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021, 3 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).