Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Overdose
Clinical narrative: A nurse administered the 1st dose of the Moderna Covid-19 vaccine to an 18-month-old patient at 0.5ml from the SDV for 6months-11years old./Amount was given 0.5 ml, not 0.25 ml; normal vaccine reactions; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (normal vaccine reactions) and OVERDOSE (A nurse administered the 1st dose of the Moderna Covid-19 vaccine to an 18-month-old patient at 0.5ml from the SDV for 6months-11years old./Amount was given 0.5 ml, not 0.25 ml) in an 18-month-old female patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch nos. AU5553B and AU5553B) for COVID-19 prophylaxis.     Concomitant products included SODIUM FLUORIDE from 22-Feb-2023 to an unknown date for Mineral supplementation, INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) from 20-Nov-2023 to an unknown date for an unknown indication.   On 01-Dec-2023 at 1:52 PM, the patient received first dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) .5 milliliter. On 29-Dec-2023 at 9:28 AM, received second dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) dosage was changed to .25 milliliter. On 01-Dec-2023 at 1:52 PM, the patient experienced OVERDOSE (A nurse administered the 1st dose of the Moderna Covid-19 vaccine to an 18-month-old patient at 0.5ml from the SDV for 6months-11years old./Amount was given 0.5 ml, not 0.25 ml). In December 2023, the patient experienced IMMUNISATION REACTION (normal vaccine reactions). On 01-Dec-2023, OVERDOSE (A nurse administered the 1st dose of the Moderna Covid-19 vaccine to an 18-month-old patient at 0.5ml from the SDV for 6months-11years old./Amount was given 0.5 ml, not 0.25 ml) had resolved. At the time of the report, IMMUNISATION REACTION (normal vaccine reactions) outcome was unknown.        For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient had no allergies to medications, food and other products. Patient had no acute illnesses at the time of vaccination and up to one month before and had no chronic or long-standing health conditions. The reporter stated that there was nowhere in the packaging that stated there was an overfill and it was actually 0.5ml that was in the vial which was way too much. It was all over that it was a single dose vial. The patient received 0.5 ml of the moderna covid-19 vaccine for 6 month-11 years. Since it was a single dose vial, it was thought that they got the whole dose. Patient had not experienced any adverse symptoms aside from normal vaccine reactions. The parents brought her back for the second dose without any complications. No treatment medications were reported.  Rationale for no investigation: In the (Privacy), the pediatric Single Dose Vial (SDV) are filled to the same volume as for adults SDV. However, the final volume for administration varies between the population groups, with pediatrics receiving 0.25ml and adults receiving 0.5ml. In both cases, the final volume of the vial will have a slight overfill. In pediatrics, as only 0.25mL from the total volume is drawn for administration, it is expected to have roughly half the vial content remaining in the vial after drawing. As instructed in the Fact Sheet for Moderna covid-19 vaccine (2023-2024 formula), for individuals 6 months through 11 years of age, section 2 "Dosage and Administration", the vial is to be discarded after single use. (https://assets.modernatx.com/m/2cbca14044aa8fa5/original/FPI-0718_Moderna-COVID-19-Vaccine-2023-2024-Formula-Fact-Sheet-for-Vaccine-Providers-6m-11y-.pdf). Additionally, the Medical Information call center has updated their FAQs for inquiries around the remaining volume in the SDV after drawing the dose. No additional investigation is recommended at this time.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2024: Significant follow-up received which contain, reporter details, patient details, concomitant medications, suspect product details, event (Immunisation reaction) added, onset time, outcome of the event (Overdose) and narrative updated.