Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified/undergone several temperature excursions; No Adverse Event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No Adverse Event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown whether patient has diagnosed/tested positive for COVID-19.     On 19-Sep-2022 at 12:19 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Sep-2022 at 12:19 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions).    On an unknown date, patient had received dose 1, dose 2, dose 3 of Moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses. Patient had received on deltoid body site for dose 4. The volume of vaccine patient received was 0.5 with an unknown unit.  No concomitant medication was provided.  It was reported that refrigeration excursions identified, state vaccine was housed in these units.  Manufactures were notified and the state department and made aware of the situation. The vials were Stored in refrigerator at the time of the excursion. There were 2 unbroken cartons and 20 vials. Two different lot numbers AS1412B and 057A22A were reported. The vials moved from freezer to refrigerator on 7-SEP-2022. The clinic which the reported was working had a similar issue with vaccines stored in the freezer. Vaccines stored in the refrigerator that underwent several temperature excursions on August 2022.  It was reported that no adverse reactions were reported to reporter's knowledge for any patients.  Treatment medication was not provided by the reporter.