Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received vaccine that underwent one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at temperature excursion; No adverse event; Patient received vaccine that underwent one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine that underwent one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine that underwent one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine that underwent one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine that underwent one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine that underwent one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine that underwent one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at temperature 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 POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine that underwent one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine that underwent one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at temperature excursion).    The patient had a weight of 25 (unit not specified). The patient had Moderna administration location on LQ (unspecified). No concomitant medications were reported. It was reported that the medical assistant had called Moderna and reported that the Moderna COVID-19 vaccine experienced one temperature excursion. Some vaccine was stored in the freezer and other vials in the refrigerator. The excursions were picked up by state review of the temperature data logger two weeks later after the excursion. The excursion occurred on 07-Aug-2022 whose storage condition at the time of the excursion was frozen storage with a minus 3.2 degrees Celsius for an excursion duration of 3 hours and 33 minutes and the vials were stored at freezer now. The visual inspection had not occurred changed in vaccine and no vaccine was refrozen. Some vials have been used on patients punctured and discarded within 12 hours. The five vials were in the freezer and two were in the refrigerator. An office practice was to take one vial from the freezer and to place the vial in the refrigerator when there was a vaccination appointment, so some vaccine underwent the excursion in the freezer and the rest of the vaccine excursion happened in the refrigerator. The patient had a positive 14 degrees Celsius temperature excursion with a duration of 3 hours and 5 minutes when the vial was moved from freezer to refrigerator on 08-Aug-2022 and maintained at room temperature then administered and discarded. The proposed desired use by date was 18-Aug-2022 and one vial was impacted. The vial was not punctured until used for a patient and then discarded. The patient side effects were none. No treatment medications were reported.