Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Overdose, Pain in extremity, Pyrexia
Clinical narrative: 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.; Painful arm; Fever to 101; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Painful arm), PYREXIA (Fever to 101) 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 5-year-old female patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. AU5556B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (Dose 1, 0.25 ml, lot/batch:AS1416B, site of administration: left deltoid at 11:37 AM.) on 25-Jul-2022, Moderna (Dose 2, 0.25 ml, lot/batch: AS1416B and site of administration: left deltoid at 12:26 PM.) on 26-Aug-2022. Past adverse reactions to the above products included No adverse event with Moderna and Moderna. Concurrent medical conditions included Seasonal allergy since 10-Jun-2022 and Astigmatism since 24-Jan-2020.    On 26-Jan-2024 at 3:02 PM, the patient received third dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (unknown route) .5 milliliter. On 26-Jan-2024, the patient experienced PAIN IN EXTREMITY (Painful arm) and PYREXIA (Fever to 101). On 26-Jan-2024 at 3:02 PM, 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 28-Jan-2024, PAIN IN EXTREMITY (Painful arm) and PYREXIA (Fever to 101) had resolved. At the time of the report, 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.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2024, Body temperature: 101.     For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Unknown), the reporter considered PAIN IN EXTREMITY (Painful arm) and PYREXIA (Fever to 101) to be 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.).    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 allergies to medications, food and other products. The patient never been diagnosed with/tested positive for COVID-19. No acute illnesses at the time of vaccination and up to one month before.  No Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken by patient at time of vaccination and/or at the time of the adverse event. No other potential causes were reported. The patient did not seek any medical care for the cause of the event. The patient did not experience a similar event in the past.   No treatment information was provided.   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 information received: Reporter, Patient's details (DOB, initials, gender, medical history) and new events (Painful arm and fever) were added. Narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-760906:Patient 5 out of 16