Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: One of the medical assistants reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time; No adverse event; One of the medical assistants reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (One of the medical assistants reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time), POOR QUALITY PRODUCT ADMINISTERED (One of the medical assistants reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    In February 2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (One of the medical assistants reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (One of the medical assistants reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (One of the medical assistants reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time), POOR QUALITY PRODUCT ADMINISTERED (One of the medical assistants reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (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 (One of the medical assistants reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time) and POOR QUALITY PRODUCT ADMINISTERED (One of the medical assistants reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time).    No concomitant medication were reported.  It was reported that one of the medical assistants reported excursion on 14-Feb-2023. Maximum temperature was -1.8 C. At time of excursion vaccine was in freezer. Excursion duration was unknown for each day, starting on 01-Feb-2023 and continued until 14-Feb-2023. Reporter said they were unable to access and print off the data logger.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712044, US-MODERNATX, INC.-MOD-2023-711958, US-MODERNATX, INC.-MOD-2023-711977, US-MODERNATX, INC.-MOD-2023-712046, US-MODERNATX, INC.-MOD-2023-712062 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Feb-2023: Follow up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712044: US-MODERNATX, INC.-MOD-2023-711958: US-MODERNATX, INC.-MOD-2023-711977: US-MODERNATX, INC.-MOD-2023-712046: US-MODERNATX, INC.-MOD-2023-712062: