Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: misleading/lack of information on the product packaging/leaflet and misunderstanding of instructions by the individual administering the medication; incorrect diluent and incorrect amount of the diluent was used/administered to patient; incorrect diluent and incorrect amount of the diluent was used/administered to patient; incorrect diluent and incorrect amount of the diluent was used/administered to patient; incorrect diluent and incorrect amount of the diluent was used/administered to patient; hand pain; This is a spontaneous report received from Nurses and Other HCPs from medical information team, Program ID.  A 2-year-old female patient received BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA)), on 13Sep2024 as dose 1, 0.3 ml single (Lot number: LN6739, Expiration Date: 31Jan2026) at the age of 2 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: HEPATITIS A VACCINE taken for immunisation, on 06Sep2024 as dose 2. Vaccination history included: Hepatitis a vaccine (DOSE 1), for immunization. The following information was reported: PRODUCT PREPARATION ISSUE (non-serious), OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 13Sep2024, outcome "unknown" and all described as "incorrect diluent and incorrect amount of the diluent was used/administered to patient"; PRODUCT PACKAGING CONFUSION (non-serious) with onset 13Sep2024, outcome "unknown", described as "misleading/lack of information on the product packaging/leaflet and misunderstanding of instructions by the individual administering the medication"; PAIN IN EXTREMITY (non-serious) with onset Sep2024, outcome "unknown", described as "hand pain". Therapeutic measures were not taken as a result of product preparation issue, overdose, product preparation error, poor quality product administered. Additional information: The nurse reported that they had an error last Friday (13Sep2024). The staff member diluted 0.7 ml sterile diluent into the pediatric dosage and then administered 0.3 cc to the patient. The staff member used a sterile water that comes with their Merck products. The staff member used 0.7ml of sterile diluent, and that was injected into the vial of Pfizer COVID-19 vaccine (BioNTech covid19 vaccine ages 6 months to 4 yrs old, 2024-2025 Formula). The staff member then withdrew 0.3 cc and administered it to the patient. The nurse reported the events as serious: Other medically important condition. The reporter asked what the next dosage is and what they need to do with the patient, or if there are any studies about it. An agent provided information that the product should be diluted/reconstituted with 0.9 sodium chloride, but the nurse reported that the product was inadvertently diluted with sterile water, and then it was given to the patient. Clarified upon transfer that it was the incorrect diluent but also the wrong quantity of diluent that was used during reconstitution. On 07Oct2024, it was reported that patient complained of hand pain on side/arm, vaccine was given for 2-3days. Furthermore, may had been normal response. The child was scheduled for second dose on 04Oct2024. Patient was not allergic to any previous vaccination, medications, food or other products. Patient did not receive any other vaccines on the same date as BNT162b2 omicron (kp.2). Events "incorrect diluent and incorrect amount of the diluent was used/administered to patient" did not require a visit to the Emergency room nor a Physician's office. Patient did not experienced any adverse event as a consequence of the overdose. The medication error occurred when the product was prepared, the reporter considered the following factors to be responsible for the medication error (vaccine delivered without diluent): misleading/lack of information on the product packaging/leaflet and misunderstanding of instructions by the individual administering the medication.  Follow-up (07Oct2024): This is a spontaneous follow up report received from Nurses and Other HCPs from medical information team, Program ID. Updated information: patient data (historical vaccine), product data (dose number and concomitant drug), event data (new events Hand pain and Product packaging confusion) and clinical course.