Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 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.; No Adverse Event; Dose was administered after the excursion happened; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose was administered after the excursion happened), 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 NO ADVERSE EVENT (No Adverse Event) in a 71-year-old male 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 if patient had any relevant medical history, conditions, allergy, concomitant diseases or risk factor. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 22-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 22-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 (Dose was administered after the excursion happened). On an unknown date, 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.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose was administered after the excursion happened), 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 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 POOR QUALITY PRODUCT ADMINISTERED (Dose was administered after the excursion happened) and 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.).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. It was reported that the excursion occurred on 04-May-2023 for 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 other adverse events were reported. Treatment medications were not provided.     Reporter did not allow further contact