Age: 1.92
Sex: U
Vaccine: COVID19, FLU3
Symptoms: Immunisation reaction, Overdose, Product administered at inappropriate site, Product preparation issue, Product use issue
Clinical narrative: increased likelihood of Reactogenicity; Runny nose; She accidentally mixed the vial with 1.3 ml of diluent instead of 2.2 ml and realized this after she had administered 5 doses; She accidentally mixed the vial with 1.3 ml of diluent instead of 2.2 ml and realized this after she had administered 5 doses; FluZone Sanofi Date: 07Oct2022; Anatomical Site of injection: left thigh; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 24-month-old patient received BNT162b2 (BNT162B2), on 07Oct2022 as dose 1 (maroon cap), single (Lot number: FT9142, Expiration Date: 31Dec2022) at the age of 23 months intramuscular, in left thigh for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 07Oct2022 as dose 4, single (Lot number: UT7682NA) intramuscular, in right thigh for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Fluzone [influenza vaccine] (Dose-1), for Immunization; Fluzone [influenza vaccine] (Dose-2), for Immunization; Fluzone [influenza vaccine] (Dose-3), for Immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 07Oct2022, outcome "unknown", described as "Anatomical Site of injection: left thigh"; PRODUCT USE ISSUE (non-serious) with onset 07Oct2022, outcome "unknown", described as "FluZone Sanofi Date: 07Oct2022"; PRODUCT PREPARATION ISSUE (non-serious), OVERDOSE (non-serious) all with onset 07Oct2022, outcome "unknown" and all described as "She accidentally mixed the vial with 1.3 ml of diluent instead of 2.2 ml and realized this after she had administered 5 doses"; RHINORRHOEA (non-serious) with onset 11Oct2022, outcome "recovered", described as "Runny nose"; IMMUNISATION REACTION (non-serious), outcome "unknown", described as "increased likelihood of Reactogenicity". Therapeutic measures were not taken as a result of rhinorrhoea.  Additional information: The nurse reported a vaccination error involving the Pfizer COVID-19 vaccine maroon cap for 6 months to under 5 years. She was running a COVID clinic today for little ones and she had consulted the COVID vaccine prep and administration summaries from the CDC website and she had gotten confused about the diluent amount and accidentally mixed the vial with 1.3 ml of diluent instead of 2.2 ml and realized this after she had administered 5 doses and could not draw anymore, up to 5 kids were administered with the vaccine; she stated that it was the last vaccine for 2 of the patients. On 11Oct2022, the patient developed a runny nose, after receiving 1st dose of 6 month less than 5 years covid vaccine has otherwise been behaving at baseline. Mother contacted by patients PCP not field of vaccine error, aware VAERS report was submitted and of increased like hood of reactogenicity.  Follow-up (10Oct2022): This is a spontaneous follow-up report received in response to the mail trail. Updated information: reporter's information.  Follow-up (13Oct2022): Follow-up attempts are completed. No further information is expected.  Follow-up (06Dec2022): This is a spontaneous follow-up report received from a contactable Nurse. This Nurse reported in response to HCP letter which included that: Updated information included: The address minor updated and alternate suffix added for slide#1 reporter. Relevant medical history added. Historical vaccine added. Reported Indication updated. Suspect drug dosage regimen (Patient Route of Administration, Anatomical Location) updated. Vaccine Administered at Facility updated. Co-suspect drug added. New events (Runny nose", "Drug use for unapproved combination", "Reactogenicity event) added.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201212961 same reporter, drug, and event; different patient;