Age: 2.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Gait disturbance, Pain in extremity, Product administered to patient of inappropriate age, Product temperature excursion issue
Clinical narrative: Administration error: vaccine administered after vial experienced an excursion; Patient was limping a lot; She felt extremely tired and sleepy; Patient was complaining because her leg hurt so bad; She felt extremely tired and sleepy; 3rd dose administered to a 3 year old patient and she was not immunocompromised; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GAIT DISTURBANCE (Patient was limping a lot), SOMNOLENCE (She felt extremely tired and sleepy), PAIN IN EXTREMITY (Patient was complaining because her leg hurt so bad), FATIGUE (She felt extremely tired and sleepy) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3rd dose administered to a 3 year old patient and she was not immunocompromised) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AS1416B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Patient had no allergies reported. No history relating to mentioned AE and there were no acute and chronic illnesses at the time of vaccination.  The patient's past medical history included COVID-19 (Was Hospitalized for 3 days and was sick for almost 2 weeks) in August 2021.   On 28-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2022, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced GAIT DISTURBANCE (Patient was limping a lot), SOMNOLENCE (She felt extremely tired and sleepy), PAIN IN EXTREMITY (Patient was complaining because her leg hurt so bad), FATIGUE (She felt extremely tired and sleepy) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3rd dose administered to a 3 year old patient and she was not immunocompromised). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Administration error: vaccine administered after vial experienced an excursion). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (Patient was limping a lot), SOMNOLENCE (She felt extremely tired and sleepy) and FATIGUE (She felt extremely tired and sleepy) had not resolved, PAIN IN EXTREMITY (Patient was complaining because her leg hurt so bad) was resolving and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3rd dose administered to a 3 year old patient and she was not immunocompromised) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administration error: vaccine administered after vial experienced an excursion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: (Positive) had COVID-19.         No concomitant medications were reported. The patient received a 3rd dose of the Moderna COVID-19 vaccine but she was only 3 years old and she was not immunocompromised. After the 3rd dose patient was complaining because her leg hurt so bad and she was limping a lot, she felt extremely tired and sleepy. Symptoms were still ongoing. The patient treated pain with Motrin. Patient was not under any concomitant or regular medication. Vaccines were given in the leg. It was reported that the symptoms were still going on. AE did not caused patient to seek medical care. Patient had not experienced a similar events in the past to this extent.    This case was linked to MOD-2022-661337, MOD-2022-661338 (Patient Link).