Age: 1.67
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Insomnia, Overdose
Clinical narrative: Difficulty with his sleep routines which started prior to the vaccine error but might be worse since then; 16 children were given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.; This spontaneous case was reported by an other health care professional and describes the occurrence of INSOMNIA (Difficulty with his sleep routines which started prior to the vaccine error but might be worse since then) and OVERDOSE (16 children were given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.) in a 20-month-old male patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. AU5556B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for an unknown indication.    The patient's past medical history included Infant premature (Preterm 34 weeks) on XX-May-2022. Concurrent medical conditions included Difficulty sleeping.   On 09-Feb-2024, the patient received dose of INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) (Intramuscular use) 1 dosage form. On 09-Feb-2024 at 9:30 AM, the patient received first dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) .5 milliliter. On 09-Feb-2024 at 9:30 AM, the patient experienced OVERDOSE (16 children were given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.). On an unknown date, the patient experienced INSOMNIA (Difficulty with his sleep routines which started prior to the vaccine error but might be worse since then). At the time of the report, INSOMNIA (Difficulty with his sleep routines which started prior to the vaccine error but might be worse since then) and OVERDOSE (16 children were given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.) outcome was unknown.        For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use), the reporter considered INSOMNIA (Difficulty with his sleep routines which started prior to the vaccine error but might be worse since then) to be not related. No further causality assessment was provided for OVERDOSE (16 children were given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.).    The patient did not have any allergies. It was unknown if he was tested positive for COVID-19.  No concomitant medications were reported.  Per reporter, between 01-Jan-2024 and 15-Feb-2024, 16 children were given the 6 to 11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml.  No treatment information was provided. This case contains information for the 12th of 16 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-760906 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2024: Significant follow-up received: Reporter added, patient's details added and medical history added, dosage regimen updated, co-suspect added, event start date and time added, event insomnia added, event no adverse event removed, inarrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-760906:Patient 12 of 16