Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes; patient were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion; No adverse reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes), POOR QUALITY PRODUCT ADMINISTERED (patient were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion) and NO ADVERSE EVENT (No adverse reaction) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013H22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes), POOR QUALITY PRODUCT ADMINISTERED (patient were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes), POOR QUALITY PRODUCT ADMINISTERED (patient were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes) and POOR QUALITY PRODUCT ADMINISTERED (patient were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion).    Concomitant medication of the patient was not reported.  Reporter reported that the refrigerator door was left open for ten minutes. Maximum and minimum temperatures reported were 49.3 degree Fahrenheit and 45.8 degree Fahrenheit respectively. There were 2 Unpunctured and1 punctured vial Lot number 060A22A and MFG Exp. Date: 28AUG2022 and 1 Punctured vial Lot number 013B22A and  MFG Exp. Date: 22NOV2022. Vials were moved from freezer to refrigerator on 25Jul2022. It was further reported that the unpunctured vial was still in the refrigerator and the punctured ones were discarded. The vials looked normal.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-627779 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2022: Live Follow Up received Lot number and Narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-627779: