Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine has been administered to patients post excursion.; Moderna COVID-19 vaccine has been administered to patients post excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine has been administered to patients post excursion.), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine has been administered to patients post excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine has been administered to patients post excursion.), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine has been administered to patients post excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine has been administered to patients post excursion.), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine has been administered to patients post excursion.) 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 WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine has been administered to patients post excursion.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine has been administered to patients post excursion.).    No concomitant medications were reported.  It was reported that there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose.  No treatment medications were reported.  This case contains information for the 51th of 104 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791, US-MODERNATX, INC.-MOD-2022-680489 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case US-MODERNATX, INC.-MOD-2022-680489:Master Case