Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: Irritability postvaccinal, Overdose, Product preparation error, Pyrexia
Clinical narrative: Fever; gave today an undiluted dose of the Pfizer 6 months to 4 years of age to a 1 year old child; gave today an undiluted dose of the Pfizer 6 months to 4 years of age to a 1 year old child; fussy behavior; This is a spontaneous report received from a Nurse from medical information team.  A 15-month-old female patient received BNT162b2 (BNT162B2), on 09Nov2022 at 13:42 as dose 2 (maroon cap), 0.2 ml single (Lot number: FT9142, Expiration Date: 30Jun2023) at the age of 15 months intramuscular, in left thigh for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: pfizer tris sucrose (dose 1, administered intramuscularly in the right thigh, Lot number: FT9142), administration date: 14Oct2022, when the patient was 14-month-old, for COVID-19 immunisation. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 09Nov2022 at 10:00, outcome "unknown" and all described as "gave today an undiluted dose of the Pfizer 6 months to 4 years of age to a 1 year old child"; PYREXIA (non-serious) with onset 11Nov2022, outcome "recovered" (11Nov2022), described as "Fever"; IRRITABILITY POSTVACCINAL (non-serious) with onset Nov2022, outcome "recovered" (Nov2022), described as "fussy behavior". Therapeutic measures were taken as a result of pyrexia, irritability postvaccinal.  The reporter considered "fever" and "fussy behavior" not related to BNT162b2.  Additional information: Dose/dosage form: Maroon cap, original (Monovalent) 6 months to 4 years-3 mcg/dose, dilute before use. Reporter enquired about an undiluted dose of the Pfizer 6 months to 4 years of age given a 0.2 ml dose; that was undiluted to a 1 year old child. They just wanted to know if there were things that they needed to watch out for and what should they tell the family. Reporter stated, believed this was extended to 6 months to 5 years (thought) that was undiluted. As of 23Jan2024, the reporting nurse (RN) stated that they had just started at the vaccine clinic as a new hire on 15Oct2022. RN had never drawn up a pediatric vaccine on their own before, however they had watched it done (had previously watched pediatric vaccine being prepared with instruction on how to dilute). RN went to draw up the vaccine by themselves and did not dilute the vaccine. RN had gathered all the supplies including the diluent, however they were feeling rushed to prepare the vaccine and was unsupervised. Having had no physical experience vaccinating or preparing vaccines, RN did not properly dilute the vaccine. RN did draw up the proper amount per recommendations, 0.2 mL, and the vaccine was administered intramuscularly by another RN. This dose was given to the patient. The mistake was not caught until later in the evening when accounting for doses to waste. The parents were called, a health history was obtained, a VAERS report was filed through the CDC, and the manufacturer was contacted. The doctor gave his contact information to the family for follow-up and recommended dosing the child with paracetamol (TYLENOL) and ibuprofen for the next 24 hours per package directions and to watch for fevers. The parents were asked to follow up with symptoms. The parents did not report any side effects other than subjective fever and fussy behavior for one day (24 hours). It was also reported that no treatment was used.   Follow-up attempts are completed.  Follow-up (23Jan2024): This is a spontaneous follow-up report received from a Nurse. Updated information included: patient details, vaccination facility details, historical vaccine details, suspect drug details, new events (fever, irritability postvaccinal), clinical course.  Follow-up attempts are completed.; Sender's Comments: Based on the given information, the Company confirms that the events pyrexia and irritability postvaccinal are unrelated to the suspected drug BNT162B2 and most likely due to an intercurrent medical condition.