Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022; No adverse event; 3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022) 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 (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (3 Adult patients received primary Monovalent doses from  red cap vial  that experienced excursion in the refrigerator on 03-OCT-2022).    Concomitant medications were not reported.   The patient received Monovalent primary dose.  The excursion occurred in the refrigerator on 03-Oct-2022 and involved 1 unpunctured red cap vial and 3 unpunctured Bivalent Booster vials.Temperature was reported as Minimum 1.76 Celsius and Maximum 1.97Celsius. Temperature excursion duration was reported as 1 Hour and 40 Minutes. On 03-Oct-2022 it was reported that 11 adult patients had received booster doses from the Bivalent vials on 03-Oct-2022  and 05-Oct-2022.                              No treatment information was provided by the reporter.  This case contains information for one of three adult patients who received primary monovalent doses described by the reporter.