Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Wrong product administered
Clinical narrative: Patients' leg, at vaccination site, was reddened and hard to the touch; Patients' leg, at vaccination site, was reddened and hard to the touch/hard swollen at inj site; Patient has had a fever; Patient is not walking; A 2 year old female patient came in and received Spikevax 2023-2024 formula (12y/o+); Patient took 0.5 ml vaccine; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of GAIT DISTURBANCE (Patient is not walking), WRONG PRODUCT ADMINISTERED (A 2 year old female patient came in and received Spikevax 2023-2024 formula (12y/o+)), OVERDOSE (Patient took 0.5 ml vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 2-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 2001526) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Respiratory Panel/Nasopharyngeal swab) on 05-Jan-2022. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1 and At 09:30AM with batch no: HH3252 at a dose of 0.3ml to Left Vastus Lateralis.) on 10-Jan-2024. Past adverse reactions to the above products included No adverse effect with Pfizer.    On 07-Feb-2024 at 10:00 AM, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 07-Feb-2024, the patient experienced GAIT DISTURBANCE (Patient is not walking), WRONG PRODUCT ADMINISTERED (A 2 year old female patient came in and received Spikevax 2023-2024 formula (12y/o+)), OVERDOSE (Patient took 0.5 ml vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). On 07-Feb-2024 at 10:00 AM, the patient experienced VACCINATION SITE ERYTHEMA (Patients' leg, at vaccination site, was reddened and hard to the touch), VACCINATION SITE SWELLING (Patients' leg, at vaccination site, was reddened and hard to the touch/hard swollen at inj site) and PYREXIA (Patient has had a fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Feb-2024, GAIT DISTURBANCE (Patient is not walking), VACCINATION SITE ERYTHEMA (Patients' leg, at vaccination site, was reddened and hard to the touch), VACCINATION SITE SWELLING (Patients' leg, at vaccination site, was reddened and hard to the touch/hard swollen at inj site) and PYREXIA (Patient has had a fever) had resolved. At the time of the report, WRONG PRODUCT ADMINISTERED (A 2 year old female patient came in and received Spikevax 2023-2024 formula (12y/o+)), OVERDOSE (Patient took 0.5 ml vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered VACCINATION SITE SWELLING (Patients' leg, at vaccination site, was reddened and hard to the touch/hard swollen at inj site) and PYREXIA (Patient has had a fever) to be not related. No further causality assessments were provided for GAIT DISTURBANCE (Patient is not walking), WRONG PRODUCT ADMINISTERED (A 2 year old female patient came in and received Spikevax 2023-2024 formula (12y/o+)), OVERDOSE (Patient took 0.5 ml vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and VACCINATION SITE ERYTHEMA (Patients' leg, at vaccination site, was reddened and hard to the touch).    Concomitant medication was not provided. Patient's parents were notified when she was in the clinic that she received incorrect dose. The patient and her parents waited 30 minutes in the clinic post-vaccination. Patient initially did not have any signs or symptoms before leaving the clinic. Patient returned the next day on 08-Feb-2024. Patient had a fever and was not walking, leg at vaccination site was reddened and hard to the touch. Parents were advised to give Tylenol, plenty of fluids, and to go to ER if fever worsens. Parents opted to treat at home. Patient was followed up the next day with parents and they reported that the patient was doing well, no fever, and was walking on her leg again.  The expiry date was reported as 31-Mar-2024.   Most recent FOLLOW-UP information incorporated above includes: On 05-Mar-2024: Follow-up received and added patient details, relevant medical history, added new events of pyrexia, gait disturbance, vaccination site erythema, vaccination site swelling, vaccine overdose, interchange of vaccine products, revaccination with different COVID-19 vaccine and updated narrative.