Age: 102.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 for 50 minutes. Maximum temperature reached was 10.5°F. A second excursion happened a couple hours later for 15 minutes, and maximum te; No adverse event; A total of 13 doses were administered after the excursion happened.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 for 50 minutes. Maximum temperature reached was 10.5°F. A second excursion happened a couple hours later for 15 minutes, and maximum tem), POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened.) and NO ADVERSE EVENT (No adverse event) in a 102-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.     It was unknown whether patient had relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 18-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-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 PRODUCT TEMPERATURE EXCURSION ISSUE (10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 for 50 minutes. Maximum temperature reached was 10.5°F. A second excursion happened a couple hours later for 15 minutes, and maximum tem) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 for 50 minutes. Maximum temperature reached was 10.5°F. A second excursion happened a couple hours later for 15 minutes, and maximum tem), 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)) (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 (10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 for 50 minutes. Maximum temperature reached was 10.5°F. A second excursion happened a couple hours later for 15 minutes, and maximum tem) and POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened.).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Dosage text for suspect product was reported as unknown.  10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04 MAY 2023 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. A total of 13 doses were administered after the excursion happened. This information was given for patient.  Concomitant medication not reported. Treatment medication not reported.   Reporter did not allow further contact