Age: 5.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Overdose, Peripheral swelling, Pyrexia, Tenderness, Wrong product administered
Clinical narrative: leg on left was more swollen and tender; leg on left was more swollen and tender; fever; Patient received the incorrect formulation of vaccine. he was meant to have received MCV 6mos-11yr formulation but, instead received Spikevax for 12yr and older; Patient received the incorrect formulation of vaccine. he was meant to have received MCV 6mos-11yr formulation but, instead received Spikevax for 12yr and older; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (leg on left was more swollen and tender), TENDERNESS (leg on left was more swollen and tender), PYREXIA (fever), WRONG PRODUCT ADMINISTERED (Patient received the incorrect formulation of vaccine. he was meant to have received MCV 6mos-11yr formulation but, instead received Spikevax for 12yr and older) and OVERDOSE (Patient received the incorrect formulation of vaccine. he was meant to have received MCV 6mos-11yr formulation but, instead received Spikevax for 12yr and older) in a 5-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. B0005) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 21-Sep-2024, the patient received fourth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter and dose of INFLUENZA VACCINE (Intramuscular use) 1 dosage form. On 21-Sep-2024, the patient experienced PERIPHERAL SWELLING (leg on left was more swollen and tender), TENDERNESS (leg on left was more swollen and tender), PYREXIA (fever), WRONG PRODUCT ADMINISTERED (Patient received the incorrect formulation of vaccine. he was meant to have received MCV 6mos-11yr formulation but, instead received Spikevax for 12yr and older) and OVERDOSE (Patient received the incorrect formulation of vaccine. he was meant to have received MCV 6mos-11yr formulation but, instead received Spikevax for 12yr and older). On 22-Sep-2024, PERIPHERAL SWELLING (leg on left was more swollen and tender), TENDERNESS (leg on left was more swollen and tender) and PYREXIA (fever) had resolved. At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the incorrect formulation of vaccine. he was meant to have received MCV 6mos-11yr formulation but, instead received Spikevax for 12yr and older) and OVERDOSE (Patient received the incorrect formulation of vaccine. he was meant to have received MCV 6mos-11yr formulation but, instead received Spikevax for 12yr and older) outcome was unknown.      For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient had fever which resolved the next morning. The other factors that could had led to adverse event was reported as the patient received influenza vaccine on the same day of SPIKEVAX 2024-2025 PFS vaccination. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2024: Significant follow-up received. Added co-suspect influenza vaccine. Updated reporter details. Added reporter, patient height, weight, race and ethnic group. Added route of administration and anatomical location of the suspect product. Added new event peripheral swelling, tenderness and fever. Updated narrative.