Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated from vials stored in freezer no DDL temp monitoring/ the dose affected was third dose) and PRODUCT STORAGE ERROR (patient vaccinated from vials stored in freezer no DDL temp monitoring) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 047C21A and 006C21A) for COVID-19 prophylaxis. No known allergy. On 04-May-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Jun-2021 at 4:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 21-Feb-2022 at 3:45 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 21-Feb-2022 at 3:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated from vials stored in freezer no DDL temp monitoring/ the dose affected was third dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient vaccinated from vials stored in freezer no DDL temp monitoring). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated from vials stored in freezer no DDL temp monitoring/ the dose affected was third dose) and PRODUCT STORAGE ERROR (patient vaccinated from vials stored in freezer no DDL temp monitoring) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information were given. Reporter stated the pharmacy hasn't been using a data digital logger to monitor the freezer temperatures that the Moderna COVID-19 vaccine stored in. It was reported that to their knowledge, there were no temperature excursion and the temperatures of the freezer remained consistently within range. They keep a written temperature log. It was reported that there was no current and previous temperature excursion. The storage condition at the time was frozen storage. The lot numbers supposedly affected were 022J21A, 083J21A, and 059M21A. Maximum or minimum temperatures were not recorded but only morning and evening temperatures were recorded. The excursion in question was from 8 Feb 2022 to 20 May 2022 and affected only 6 patients within that time frame. The vials were moved to the refrigerator to be thawed for vaccinations on 8 Feb 2022, 21 Feb 2022, 31 Mar 2022, 2 May 2022, and 20 May 2022. There were no excursion with first two doses because it was store in an approved refrigerator with DDL. The dose affected was third dose and patient did not experienced an adverse reaction to vaccine. No treatment information were given. This case was linked to US-MODERNATX, INC.-MOD-2022-592093 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2022: significant follow up received contains medical history added, dosage information and Narrative updated. New event of poor quality vaccine administered was added based on initial and follow up information. Sender's Comments: US-MODERNATX, INC.-MOD-2022-592093: master case.