Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product preparation error, Product storage error
Clinical narrative: Vaccine that had been re-frozen and thawed a second time was administered; Placed in freezer instead of refrigerator upon arrival to clinic site/Vaccine that had been re-frozen and thawed a second time was administered/-5 F was the minimum temperature reached; No adverse event; Vaccine that had been re-frozen and thawed a second time was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine that had been re-frozen and thawed a second time was administered), PRODUCT PREPARATION ERROR (Vaccine that had been re-frozen and thawed a second time was administered), PRODUCT STORAGE ERROR (Placed in freezer instead of refrigerator upon arrival to clinic site/Vaccine that had been re-frozen and thawed a second time was administered/-5 F was the minimum temperature reached) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 052B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 11-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine that had been re-frozen and thawed a second time was administered). On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (Vaccine that had been re-frozen and thawed a second time was administered), PRODUCT STORAGE ERROR (Placed in freezer instead of refrigerator upon arrival to clinic site/Vaccine that had been re-frozen and thawed a second time was administered/-5 F was the minimum temperature reached) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine that had been re-frozen and thawed a second time was administered), PRODUCT PREPARATION ERROR (Vaccine that had been re-frozen and thawed a second time was administered), PRODUCT STORAGE ERROR (Placed in freezer instead of refrigerator upon arrival to clinic site/Vaccine that had been re-frozen and thawed a second time was administered/-5 F was the minimum temperature reached) 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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine that had been re-frozen and thawed a second time was administered), PRODUCT PREPARATION ERROR (Vaccine that had been re-frozen and thawed a second time was administered) and PRODUCT STORAGE ERROR (Placed in freezer instead of refrigerator upon arrival to clinic site/Vaccine that had been re-frozen and thawed a second time was administered/-5 F was the minimum temperature reached).    Concomitant product use was not provided by the reporter.  Vaccine that had been re-frozen and thawed a second time was administered.  It was reported that -5 F was the minimum temperature reached. Was in freezer for approximately 6 hours on 10-Aug-2022.  The vial was thawed from freezer for administration and was re-frozen.  Number of vial included was 1 vial.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2022: Live follow-up information received included updated reporter contact information and dose details.