Age: 9.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fatigue, Off label use, Overdose, Pain in extremity, Product use issue
Clinical narrative: Additional vaccines administered on same date of the Pfizer suspect: flu shot; Additional vaccines administered on same date of the Pfizer suspect: flu shot; Received 2 ml instead of 0.2ml; Sore arm; Fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) from medical information team.  A 9-year-old female patient received BNT162b2 (BNT162B2), on 15Sep2022 at 14:00 as dose 1 (orange cap), 2 ml single (Lot number: FL8094, Expiration Date: 31Dec2022) at the age of 9 years intramuscular, in left deltoid for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 15Sep2022 as dose 2, single (Lot number: UJ878AA) intramuscular, in right deltoid for immunisation. The patient's relevant medical history included: "Streptococcal infection", start date: 01May2022, stop date: 11May2022, notes: Strep. There were no concomitant medications. Vaccination history included: Fluzone (Dose 1, Manufacturer: Sanofi). The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "Sore arm"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 15Sep2022 at 14:00, outcome "unknown" and all described as "Additional vaccines administered on same date of the Pfizer suspect: flu shot"; OVERDOSE (non-serious) with onset 15Sep2022 at 14:00, outcome "unknown", described as "Received 2 ml instead of 0.2ml". Therapeutic measures were not taken as a result of off label use, product use issue, overdose. Therapeutic measures were taken as a result of pain in extremity, fatigue. Additional information: Medical assistant calling in about the Pfizer Covid 19 Orange cap formulation (NDC number: 59267-1055-1). The vaccine was administered to a 9 year old female patient. She received 2 ml instead of 0.2ml. This was her first dose. Caller wants guidance on what to do next. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The event did not require a visit to emergency room or physician Office; No medical treatment required. The type of medication error was Administration/dosing. The stage of medication error (e.g., prescribing, dispensing, preparation, and administration) was Administration (10X the correct dose). Contributing factors to the medication error was Training. The medication error affected the patient with clinical consequences of Sore arm, fatigue. Treatment received was just Tylenol and Supportive care. The physician did not consider the Pfizer product had a causal effect to the adverse event.  The information on the batch/lot number for BNT162b2, has been requested and will be submitted if and when received.  Follow-up (16Sep2022 and 20Sep2022): This is a spontaneous follow-up report from a contactable Other HCP. Updated information included: suspect product information (date and time of vaccination, lot number, expiry date, NDC number, administration route, anatomical location), concomitant medication (flu shot), medical history (none), event details (no medical treatment required, no visit to emergency room or physician office), new event "Additional vaccines administered on same date of the Pfizer suspect: flu shot".  Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Dose number updated as '1' and LRN was updated.  Follow-up (04Oct2022): This is a spontaneous follow-up report from a contactable physician.  Updated information includes: Reporter #02 was updated as true reporter. New reporter was added, patient date of birth was added. Historical vaccine added for dose 1 of Fluzone, Medical History added, Vaccine start time was updated, information of Co-suspect vaccine Fluzone. Event onset time was updated. New events sore arm and fatigue were added.