Age: 47.0
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 47-year-old male 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 2:18 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 2:25 PM, received 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 (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 reported as 47.08 on 02-Mar-2021 and 47.15 on 30-Mar-2021.  No concomitant and treatment medication reported.  Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27 degrees Fahrenheit at 09:00 AM, 29 degrees at 10:00 AM, 32 degrees at 11:00 AM, 33 degrees at 12:00 PM, 35 degrees at 02:00 PM and 36 degrees at 03:00 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. On 02-Mar-2021, Liquid vaccine stored in the cooler experienced a temperature excursion to a minimum temperature of 27 Degree Fahrenheit and was out of range for 6 hours. Based on the information provided it was possible the vaccine would have started to refreeze and then thawed prior to administration. Batch number 014M20A vial was stored on cooler 1, on 27-Feb-2021, 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, 5 PM: 37. 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-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021.  On 30-Mar-2021, Liquid vaccine stored in the cooler experienced a temperature excursion to a minimum temperature of 33 degree Fahrenheit and was out of range for 1 hour. 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 traceable temperature monitor at every hour.   This case was linked to MOD-2022-566976 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2022: Live follow-up received contain significant information include new reporters details and narrative updated. On 23-May-2022: Live follow-up received contain Non significant information. On 23-May-2022: Live follow-up received contain significant information include suspect product expiration date updated. On 24-May-2022: Live follow-up received contain No new information.