Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Gait inability, Illness, Product label confusion, Pyrexia
Clinical narrative: Explained the confusion around the bottle labelling; Was given 0.5 ml when they needed 0.25 ml; After vaccine dad informed that she was very sick could not walk for 3 days and fever for 3 days but now doing better; After vaccine dad informed that she was very sick could not walk for 3 days and fever for 3 days but now doing better; After vaccine dad informed that she was very sick could not walk for 3 days and fever for 3 days but now doing better; This spontaneous case was reported by a medical assistant and describes the occurrence of ILLNESS (After vaccine dad informed that she was very sick could not walk for 3 days and fever for 3 days but now doing better), GAIT INABILITY (After vaccine dad informed that she was very sick could not walk for 3 days and fever for 3 days but now doing better), PYREXIA (After vaccine dad informed that she was very sick could not walk for 3 days and fever for 3 days but now doing better), PRODUCT LABEL CONFUSION (Explained the confusion around the bottle labelling) and ACCIDENTAL OVERDOSE (Was given 0.5 ml when they needed 0.25 ml) in a 7-year-old female patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. 031322) for COVID-19 prophylaxis.     Concomitant products included QUADRACEL, HEPATITIS B VACCINE RHBSAG (YEAST) (RECOMBIVAX), INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) and HEPATITIS A VACCINE INACT (VAQTA) for an unknown indication.    On 24-Oct-2023, the patient received first dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) .5 milliliter. In October 2023, the patient experienced ILLNESS (After vaccine dad informed that she was very sick could not walk for 3 days and fever for 3 days but now doing better), GAIT INABILITY (After vaccine dad informed that she was very sick could not walk for 3 days and fever for 3 days but now doing better) and PYREXIA (After vaccine dad informed that she was very sick could not walk for 3 days and fever for 3 days but now doing better). On 24-Oct-2023, the patient experienced ACCIDENTAL OVERDOSE (Was given 0.5 ml when they needed 0.25 ml). On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (Explained the confusion around the bottle labelling). In October 2023, ILLNESS (After vaccine dad informed that she was very sick could not walk for 3 days and fever for 3 days but now doing better), GAIT INABILITY (After vaccine dad informed that she was very sick could not walk for 3 days and fever for 3 days but now doing better) and PYREXIA (After vaccine dad informed that she was very sick could not walk for 3 days and fever for 3 days but now doing better) had resolved. At the time of the report, PRODUCT LABEL CONFUSION (Explained the confusion around the bottle labelling) and ACCIDENTAL OVERDOSE (Was given 0.5 ml when they needed 0.25 ml) outcome was unknown.        For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use), the reporter considered PRODUCT LABEL CONFUSION (Explained the confusion around the bottle labelling) and ACCIDENTAL OVERDOSE (Was given 0.5 ml when they needed 0.25 ml) to be not related. No further causality assessments were provided for ILLNESS (After vaccine dad informed that she was very sick could not walk for 3 days and fever for 3 days but now doing better), GAIT INABILITY (After vaccine dad informed that she was very sick could not walk for 3 days and fever for 3 days but now doing better) and PYREXIA (After vaccine dad informed that she was very sick could not walk for 3 days and fever for 3 days but now doing better).    Concomitant medication use information was not provided by reporter.  Patient had no allergies.  It was unknown if patient ever been diagnosed with/tested positive for COVID-19.  The patient did not have any acute illnesses at the time of vaccination and up to one month before.  The patient did not have any chronic or long-standing health conditions.  Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination and/or at the time of adverse event was unknown.  Event did not even cause the patient to seek medical care. Patient did not have any other potential causes. Patient did not experience a similar event in the past.  Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-747540 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747540:Master case