Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: second excursion details requested:lot#011H22A 12/29/2022- excursion time:90minutes/12/30/2022: excursion:140 minutes; No adverse event; second excursion details requested:lot#011H22A 12/29/2022 -excursion time:90minutes/12/30/2022: excursion:140 minutes; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (second excursion details requested:lot#011H22A 12/29/2022 -excursion time:90minutes/12/30/2022: excursion:140 minutes), PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested:lot#011H22A 12/29/2022- excursion time:90minutes/12/30/2022: excursion:140 minutes) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2022, 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 29-Dec-2022,  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 (second excursion details requested:lot#011H22A 12/29/2022 -excursion time:90minutes/12/30/2022: excursion:140 minutes). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested:lot#011H22A 12/29/2022- excursion time:90minutes/12/30/2022: excursion:140 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (second excursion details requested:lot#011H22A 12/29/2022 -excursion time:90minutes/12/30/2022: excursion:140 minutes), PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested:lot#011H22A 12/29/2022- excursion time:90minutes/12/30/2022: excursion:140 minutes) 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 (second excursion details requested:lot#011H22A 12/29/2022 -excursion time:90minutes/12/30/2022: excursion:140 minutes) and PRODUCT TEMPERATURE EXCURSION ISSUE (second excursion details requested:lot#011H22A 12/29/2022- excursion time:90minutes/12/30/2022: excursion:140 minutes).    No concomitant medications were reported.  It was reported that vaccine received and stored at 36f to 46f in refrigeration on 05-Dec-2022.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-694885, US-MODERNATX, INC.-MOD-2023-694859 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2023: Non-significant follow-up appended On 05-Jan-2023: Live significant FU (Patient information added); Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694885:Same reporter US-MODERNATX, INC.-MOD-2023-694859:Same reporter