Age: 3.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLUX
Symptoms: Fatigue, Irritability, Off label use, Overdose, Product preparation error
Clinical narrative: The child received 10 doses.; administered the full vial, undiluted; Off label use; Product use for unapproved combination; had soreness at her right arm injection site; a little fatigued and cranky; a little fatigued and cranky; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 3-year-old female patient received BNT162b2 (BNT162B2), on 30Sep2022 at 11:00 as dose 2 (maroon cap), single (Lot number: FT9142, Expiration Date: 01Nov2022) at the age of 3 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 30Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1 (MAROON CAP), SINGLE, NCD: 59267-0078-1, lot: FT9142, Pfizer), administration date: 01Sep2022, when the patient was 3-year-old, for Covid-19 Immunization. The following information was reported: IRRITABILITY (non-serious), FATIGUE (non-serious) all with onset 30Sep2022, outcome "recovered" (02Oct2022) and all described as "a little fatigued and cranky"; VACCINATION SITE PAIN (non-serious) with onset 30Sep2022, outcome "recovered" (02Oct2022), described as "had soreness at her right arm injection site"; OFF LABEL USE (non-serious) with onset 30Sep2022 at 11:00, outcome "unknown"; PRODUCT USE ISSUE (non-serious) with onset 30Sep2022 at 11:00, outcome "unknown", described as "Product use for unapproved combination"; OVERDOSE (non-serious) with onset 30Sep2022 at 11:00, outcome "unknown", described as "The child received 10 doses."; PRODUCT PREPARATION ERROR (non-serious) with onset 30Sep2022 at 11:00, outcome "unknown", described as "administered the full vial, undiluted".  Additional Information: Warm transfer from (name) Pfizer Medical Information INT-#. Reporting an incident with one of their patients. It was a 3-year-old girl patient. She has received the COVID vaccine from Pfizer -maroon cap. The nurse administered the full vial, undiluted. The child received 10 doses. The child is fine. The caller confirmed the details provided by the transferring agent. This happened during the immunizations clinic.This occurred about 11 am this morning  30Sep2022. Seriousness: it is serious to have a med error like this, but the baby is fine. She was fine during the 15-minute observation. It is not disabling at this time. They are expecting an increased systemic response. She also received the flu shot today. This was her second dose of the COVID vaccine. She didn't have any medications listed on her consent form .Patient's Medical History (including any illness at time of vaccination):   Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity:  no. Relevant Tests: List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI): no. Caller is an Manager with (city name) (state name) health department. One of her nurses administered 1 full vial of undiluted Pfizer BioNtech Covid vaccine maroon cap to a 3yo girl. Child waited customary 15min post vaccine dose and was fine. Error was noticed later when they were counting the doses. Child received 10 doses of the undiluted product. Event occurred today. Wants to know the procedure to follow post administration. On 03Oct2022, according to the call recording, the reporter stated that a 3-year-old female patient was administered the contents of a full undiluted vial, which contains 10 doses; so, 1 child received 10 doses. Upon follow up on 17Oct2022, it was reported that the phone out 3:15pm. Phone answered by reporter who provided an update. She spoke to the parents who said the patient had soreness at her right arm injection site and was a little fatigued and cranky that Friday. By Sunday she was back to her normal self and running around playing and was fine now.  Follow-up (03Oct2022): This is a spontaneous follow-up report received in response to the mail trail sent confirming that 1 child received 10 doses. Updated information includes: additional clinical details.  Follow-up attempts are completed. No further information is expected.  Follow-up (17Oct2022): This is a spontaneous follow-up report from a contactable Other HCP. This Other HCP reported in response to HCP letter sent via telephonic follow-up activity. Updated information included: New events (Product use for unapproved combination, Off label use vaccination site pain, irritability, and fatigue) and Additional information added.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The event of Overdose is assessed as related to suspect drug BNT162b2