Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis, Overdose, Pyrexia
Clinical narrative: Patient was given the 6-11 year old vaccine, however, patient was given (drawn up) the entire contents of the vial which came out to 0.5 ml.; Tactive Low Grade Fever; Dermatitis; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Tactive Low Grade Fever), DERMATITIS (Dermatitis) and OVERDOSE (Patient was given the 6-11 year old vaccine, however, patient was given (drawn up) the entire contents of the vial which came out to 0.5 ml.) in a 9-month-old male patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch nos. AU5559B and AU5556B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Presumed COVID due to exposure) on 21-Aug-2023. Concurrent medical conditions included Positional plagiocephaly (No recent changes in condition status.) since 28-Mar-2023.   On 06-Dec-2023 at 9:39 AM, the patient received first dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) .25 milliliter. On 09-Jan-2024 at 9:41 AM, received second dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) dosage was changed to .5 milliliter. On 06-Dec-2023, the patient experienced DERMATITIS (Dermatitis). On 09-Jan-2024, the patient experienced PYREXIA (Tactive Low Grade Fever). On 09-Jan-2024 at 9:41 AM, the patient experienced OVERDOSE (Patient was given the 6-11 year old vaccine, however, patient was given (drawn up) the entire contents of the vial which came out to 0.5 ml.). On 09-Jan-2024, PYREXIA (Tactive Low Grade Fever) had resolved. At the time of the report, DERMATITIS (Dermatitis) and OVERDOSE (Patient was given the 6-11 year old vaccine, however, patient 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 PYREXIA (Tactive Low Grade Fever) to be related. No further causality assessments were provided for DERMATITIS (Dermatitis) and OVERDOSE (Patient was given the 6-11 year old vaccine, however, patient was given (drawn up) the entire contents of the vial which came out to 0.5 ml.).    This case contains information for the 1st of 16 patients described by the reporter.  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. Concomitant medication was not provided. 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. Patient was taken to daycare the same day after his vaccine. He developed a tactive low-grade fever in the afternoon of 09-Jan-2024. The patient had similar low-grade fever with other vaccines in past.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-760910, US-MODERNATX, INC.-MOD-2024-760911, US-MODERNATX, INC.-MOD-2024-760915, US-MODERNATX, INC.-MOD-2024-760918, US-MODERNATX, INC.-MOD-2024-760919, US-MODERNATX, INC.-MOD-2024-760920, US-MODERNATX, INC.-MOD-2024-760921, US-MODERNATX, INC.-MOD-2024-760922, US-MODERNATX, INC.-MOD-2024-760926, US-MODERNATX, INC.-MOD-2024-760936, US-MODERNATX, INC.-MOD-2024-760942, US-MODERNATX, INC.-MOD-2024-760948, US-MODERNATX, INC.-MOD-2024-760956, US-MODERNATX, INC.-MOD-2024-760961, US-MODERNATX, INC.-MOD-2024-760962 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2024: Follow-up received and added reporters, added patient details, added relevant medical history, updated suspect details, added dosage regimen to suspect, added onset date of event Overdose, added new events of Dermatitis, Low grade fever and updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-760911:Patient 3 out of 16 US-MODERNATX, INC.-MOD-2024-760922:Patient 9 of 16 US-MODERNATX, INC.-MOD-2024-760919:Patient 6 out of 16 US-MODERNATX, INC.-MOD-2024-760915:Patient 4 out of 16 US-MODERNATX, INC.-MOD-2024-760918:Patient 5 out of 16 US-MODERNATX, INC.-MOD-2024-760921:Patient 8 out of 16 US-MODERNATX, INC.-MOD-2024-760920:Patient 7 out of 16 US-MODERNATX, INC.-MOD-2024-760910:Patient 2 out of 16 US-MODERNATX, INC.-MOD-2024-760926:Patient 10 of 16 US-MODERNATX, INC.-MOD-2024-760942:Patient 12 of 16 US-MODERNATX, INC.-MOD-2024-760936:Patient 11 of 16 US-MODERNATX, INC.-MOD-2024-760962:Patient 16 out of 16 US-MODERNATX, INC.-MOD-2024-760956:Patient 14 out of 16 US-MODERNATX, INC.-MOD-2024-760961:Patient 15 out of 16 US-MODERNATX, INC.-MOD-2024-760948:Patient 13 out of 16