Age: 83.0
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 04-May-2023 for 50 minutes. Maximum temperature reached was 10.5-degree Fahrenheit. A second excursion happened a couple hours later for 15 minute; No advese 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 POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-May-2023 for 50 minutes. Maximum temperature reached was 10.5-degree Fahrenheit. A second excursion happened a couple hours later for 15 minute) and NO ADVERSE EVENT (No advese event) in an 83-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 or conditions, allergy, concomitant diseases and risk factor were unknown.     On 05-Jun-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 05-Jun-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 04-May-2023 for 50 minutes. Maximum temperature reached was 10.5-degree Fahrenheit. A second excursion happened a couple hours later for 15 minute) and NO ADVERSE EVENT (No advese event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-May-2023 for 50 minutes. Maximum temperature reached was 10.5-degree Fahrenheit. A second excursion happened a couple hours later for 15 minute) and NO ADVERSE EVENT (No advese 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 advese event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened) and PRODUCT TEMPERATURE EXCURSION ISSUE (10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04-May-2023 for 50 minutes. Maximum temperature reached was 10.5-degree Fahrenheit. A second excursion happened a couple hours later for 15 minute).    Patient did received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case contains information about patient 11th out of 13 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-728417 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728417:Master case (Patient 1)