Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product preparation error
Clinical narrative: accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 months to 5 years that was previously reconstituted with 1.3 mL of normal saline; No adverse event; On 06-APR-2023 a colleague accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 months to 5 years that was previously reconstituted with 1.3 mL of normal saline; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT PREPARATION ERROR (accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 months to 5 years that was previously reconstituted with 1.3 mL of normal saline), POOR QUALITY PRODUCT ADMINISTERED (On 06-APR-2023 a colleague accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 months to 5 years that was previously reconstituted with 1.3 mL of normal saline) and NO ADVERSE EVENT (No adverse event) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (On 06-APR-2023 a colleague accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 months to 5 years that was previously reconstituted with 1.3 mL of normal saline). On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 months to 5 years that was previously reconstituted with 1.3 mL of normal saline) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT PREPARATION ERROR (accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 months to 5 years that was previously reconstituted with 1.3 mL of normal saline), POOR QUALITY PRODUCT ADMINISTERED (On 06-APR-2023 a colleague accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 months to 5 years that was previously reconstituted with 1.3 mL of normal saline) 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 PREPARATION ERROR (accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 months to 5 years that was previously reconstituted with 1.3 mL of normal saline) and POOR QUALITY PRODUCT ADMINISTERED (On 06-APR-2023 a colleague accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 months to 5 years that was previously reconstituted with 1.3 mL of normal saline).    Patient's relevant medical history/conditions, allergy, concomitant diseases and risk factor were not known. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.