Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No Adverse Event; A total of 13 doses were administered after the excursion happened; HCP stated 10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minutes. Maximum temperature reached was 10.5°F; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated 10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minutes. Maximum temperature reached was 10.5°F), POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened) and NO ADVERSE EVENT (No Adverse Event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     Patient relevant medical history/conditions, allergy, concomitant diseases and risk factor was unknown.     On 15-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 04-May-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated 10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minutes. Maximum temperature reached was 10.5°F). On 15-May-2023,  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 (A total of 13 doses were administered after the excursion happened). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated 10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minutes. Maximum temperature reached was 10.5°F), POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated 10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minutes. Maximum temperature reached was 10.5°F) and POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened).    No concomitant medication was reported.  HCP stated 10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minutes. Maximum temperature reached was 10.5°F. A second excursion happened a couple hours later during 15 minutes and maximum temperature reached was 9.3°F. No treatment information was reported.      Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728417: