Age: 1.0
Sex: M
Vaccine: COVID19, HEPA, MMR, PNC15, VARCEL
Symptoms: Accidental overdose, Pyrexia, Wrong product administered
Clinical narrative: The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/was given 0.5 ml when it needed to be 0.25 ml; 12 month old administered with Spikevax 2023- 2024 formula instead of Moderna Covid-19 vaccine 2023-2024 formula; low-grade fever; This spontaneous case was reported by a medical assistant and describes the occurrence of PYREXIA (low-grade fever), ACCIDENTAL OVERDOSE (The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/was given 0.5 ml when it needed to be 0.25 ml) and WRONG PRODUCT ADMINISTERED (12 month old administered with Spikevax 2023- 2024 formula instead of Moderna Covid-19 vaccine 2023-2024 formula) in a 12-month-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3914B) for COVID-19 prophylaxis.    Co-suspect products included non-company products PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) for an unknown indication, MMR II for an unknown indication, VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for an unknown indication and HEPATITIS A VACCINE INACT (VAQTA) for an unknown indication.    The patient had no allergies to medications, food or other products. The patient was never diagnosed or tested positive with COVID-19. Patient had no acute or chronic long-standing health conditions at the time of vaccination.    On 19-Oct-2023, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter, fourth dose of PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) (Intramuscular use) 1 dosage form, first dose of MMR II (Subcutaneous use) 1 dosage form, first dose of VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) (Subcutaneous use) 1 dosage form and first dose of HEPATITIS A VACCINE INACT (VAQTA) (Intramuscular use) 1 dosage form. In October 2023, the patient experienced PYREXIA (low-grade fever). On 19-Oct-2023, the patient experienced ACCIDENTAL OVERDOSE (The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/was given 0.5 ml when it needed to be 0.25 ml) and WRONG PRODUCT ADMINISTERED (12 month old administered with Spikevax 2023- 2024 formula instead of Moderna Covid-19 vaccine 2023-2024 formula). In October 2023, PYREXIA (low-grade fever) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/was given 0.5 ml when it needed to be 0.25 ml) and WRONG PRODUCT ADMINISTERED (12 month old administered with Spikevax 2023- 2024 formula instead of Moderna Covid-19 vaccine 2023-2024 formula) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter considered ACCIDENTAL OVERDOSE (The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/was given 0.5 ml when it needed to be 0.25 ml) to be not related. No further causality assessments were provided for PYREXIA (low-grade fever) and WRONG PRODUCT ADMINISTERED (12 month old administered with Spikevax 2023- 2024 formula instead of Moderna Covid-19 vaccine 2023-2024 formula).    No relevant concomitant medications were reported.  Patient had low grade fever for 24 hours after vaccine administration.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747540 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747540:Master case (Patient 1)