Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product administered to patient of inappropriate age, Product preparation issue, Pyrexia
Clinical narrative: know other than you know the fever; Administered Pfizer COVID19 vaccine, orange cap to a 2-year-old female/dose of 5.7 mcg instead of 3 mcg; Administered Pfizer COVID19 vaccine, orange cap to a 2-year-old female/two and half year old; followed the directions for dilution for the maroon cap and diluted the orange cap with 2.2mL of sterile 0.9% sodium chloride; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team.  A 2-year-old female patient received BNT162b2 (BNT162B2), on 14Nov2022 as dose 1 (orange cap), single (Batch/Lot number: unknown) at the age of 2 years for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious) with onset 14Nov2022, outcome "unknown", described as "Administered Pfizer COVID19 vaccine, orange cap to a 2-year-old female/dose of 5.7 mcg instead of 3 mcg"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 14Nov2022, outcome "unknown", described as "Administered Pfizer COVID19 vaccine, orange cap to a 2-year-old female/two and half year old"; PRODUCT PREPARATION ISSUE (non-serious) with onset 14Nov2022, outcome "unknown", described as "followed the directions for dilution for the maroon cap and diluted the orange cap with 2.2mL of sterile 0.9% sodium chloride"; PYREXIA (non-serious), outcome "unknown", described as "know other than you know the fever". Additional information: The patient was 3 feet tall and 0.81 inches. Physician stated that the nurse inadvertently administered the Pfizer COVID-10 (monovalent) orange cap vaccine instead of the maroon cap to a 2-and-a-half-year-old patient as her first dose. The nurse instantly grabbed the orange vial instead of the maroon cap and diluted it with 2.2 ml of normal saline. The patient was clinically doing okay. Upon follow up (16Nov2022), physician stated, "So, we have a two and half year old who inadvertently the nurse used the orange bottle that was recommended for the 5-year-old to 11-year-old through. She inadvertently grab the wrong bottle and she diluted it with the 2.2 ml of the same in which she would have diluted the six month to 4 year old dose normally but she just grab the wrong bottle, and so by reporter calculation, reporter believe that 2 years old got the dose of 5.7 mcg instead of 3 mcg and reporter just wanted to check if there was any particular adverse event that we know other than you know the fever (Further clarifications unknown if patient is experiencing fever or not), or watch for and also if there is any guidance when the next dose should be like that".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up(16Nov2022): This is a spontaneous follow-up report received from a contactable physician. This physician reported for a patient that: Updated information included: Reporter details updated, patient detail updated, suspect vaccine details updated, additional information updated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (16Nov2022): This is a spontaneous follow-up report received from a contactable physician. Updated information included: Event fever added. Event verbatim and clinical course updated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.