Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Overdose, 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; Fever; Body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever), MYALGIA (Body aches) 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 7-year-old male patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. AU5554B) for COVID-19 prophylaxis.     It was unknown that the patient ever been diagnosed with or tasted positive for covid-19.  The patient's past medical history included Cardiac murmur on 16-Apr-2021. Concurrent medical conditions included Nocturnal enuresis since 23-Jan-2024.    On 13-Feb-2024 at 3:59 AM, the patient received first dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) .5 milliliter. On 15-Feb-2024, the patient experienced PYREXIA (Fever) and MYALGIA (Body aches). On an unknown date, 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 16-Feb-2024, PYREXIA (Fever) and MYALGIA (Body aches) 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 15-Feb-2024, Body temperature: 42 degree Celsius.     The action taken with mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use), the reporter considered PYREXIA (Fever) and MYALGIA (Body aches) 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).    This case contains information for the 15th of 16 patients described by the reporter.  No concomitant medication was reported.  It was reported that 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.  There were 5 different lots involved, AU5556 with expiry date 08-Jun-2024, AU5554 with expiry date 06-Jun-2024, AU5558 with expiry date 15-Jun-2024, AU5551 with expiry date 30-May-2024 and AU5555 with expiry date 07-Jun-2024.  The event did not cause patient to seek medical care. It was unknown that there were other potential causes. The patient did not experience similar events in the past. The patient had severe body aches that limited mobility and 2 days. patient mother stated that he had a full recovery and felt back to normal on day 3 after vaccine.  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 received: Patient's demographics information, dose number, start date, route of administration, location of injection for suspect product, events (fever, body aches), lab data, medical history has been added and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-760906:Patient 15 out of 16