Age: 18.0
Sex: M
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; 5 patients were administered the vaccine after it suffered a temperature excursion; No adverse event; 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 (5 patients were administered the vaccine after it suffered a temperature excursion) and NO ADVERSE EVENT (No adverse event) in an 18-year-old male patient who received mRNA-1273 (Spikevax) 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 (5 patients were administered the vaccine after it suffered a temperature excursion) and NO ADVERSE EVENT (No adverse event). 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 (5 patients were administered the vaccine after it suffered a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) 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 (5 patients were administered the vaccine after it suffered a temperature excursion).    No concomitant medication was provided.  The 5 patients received vaccine that experienced excursion in the refrigerator. The refrigerator door was left open for 10 minutes.   The 2 Unpunctured and 1 punctured vial Lot number 060A22A and manufacturing expiry date 28 Aug 2022 and 1 Punctured vial Lot 013B22A and manufacturing expiry date 22 Nov 2022.  Maximum or minimum temperatures reached,  Max 49.3 degree F and Min 45.8F and  Excursion duration was 10 minutes.  The vial moved from freezer to refrigerator on 25 Jul 2022.  The unpunctured vial was still in the refrigerator and the punctured ones discarded. There was not a previous excursion and during visual inspection before vaccination it was normal. Before this there was no prior temperature excursion.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-627779 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2022: Live Follow up received contains significant Information include updated lot numbers and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-627779: