Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Monovalent vaccine that incurred a temperature excursion on 26-SEP-2022 the temperature reached minus 14.8 degrees Celsius for 5 minutes.; Patients received the Moderna Covid-19 vaccine after it had undergone a temperature excursion; Monovalent vaccine stored in freezer and temperature reached minus 14.8 degrees Celsius for 5 minutes; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent vaccine that incurred a temperature excursion on 26-SEP-2022 the temperature reached minus 14.8 degrees Celsius for 5 minutes.), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid-19 vaccine after it had undergone a temperature excursion), PRODUCT STORAGE ERROR (Monovalent vaccine stored in freezer and temperature reached minus 14.8 degrees Celsius for 5 minutes) and NO ADVERSE EVENT (No Adverse Event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent vaccine that incurred a temperature excursion on 26-SEP-2022 the temperature reached minus 14.8 degrees Celsius for 5 minutes.), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid-19 vaccine after it had undergone a temperature excursion), PRODUCT STORAGE ERROR (Monovalent vaccine stored in freezer and temperature reached minus 14.8 degrees Celsius for 5 minutes) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Monovalent vaccine that incurred a temperature excursion on 26-SEP-2022 the temperature reached minus 14.8 degrees Celsius for 5 minutes.), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid-19 vaccine after it had undergone a temperature excursion), PRODUCT STORAGE ERROR (Monovalent vaccine stored in freezer and temperature reached minus 14.8 degrees Celsius for 5 minutes) 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 (Monovalent vaccine that incurred a temperature excursion on 26-SEP-2022 the temperature reached minus 14.8 degrees Celsius for 5 minutes.), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid-19 vaccine after it had undergone a temperature excursion) and PRODUCT STORAGE ERROR (Monovalent vaccine stored in freezer and temperature reached minus 14.8 degrees Celsius for 5 minutes).    It was reported that patient was pediatric patient. It was reported that temperature excursion occur on 26-SEP-2022. No concomitant information was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2022: Significant follow-up received contains patient identifiers added and report type updated from invalid to spontaneous.