FluZone Sanofi Date: 07Oct22; Pneumonia; 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; Infiltrate on bronchiolitis; High WBC; High AST & ALT; High AST & ALT; RSV; Cough; Nasal congestion; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 3-year-old patient received BNT162b2 (BNT162B2), on 07Oct2022 as dose 1 (maroon cap), single (Lot number: FT9142, Expiration Date: 31Dec2022), in right thigh for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 07Oct2022 as dose 4, single (Lot number: UT7680MA) intramuscular, in left thigh. The patient's relevant medical history included: "Mom did not inform office staff patient developed hive", start date: 06Oct2022 (unspecified if ongoing), notes: Mom did not inform office staff patient developed hive on 06Oct2022.; "Cough", start date: 17Sep2022, stop date: 23Oct2022, notes: covid vaccine did not affect patient condition patient were improving, prior to receiving vaccine.; "Nasal congestion", start date: 17Sep2022, stop date: 23Oct2022, notes: covid vaccine did not affect patient condition patient were improving, prior to receiving vaccine.; "as patient(s) mom did not notify RN of rash which developed the night before patient received covid vaccine" (unspecified if ongoing), notes: developed the night before patient received covid vaccine. The patient's concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset 2022, outcome "recovered"; NASAL CONGESTION (non-serious) with onset 2022, outcome "recovered"; PRODUCT PREPARATION ISSUE (hospitalization, medically significant) with onset 07Oct2022, outcome "unknown", described as "She accidentally mixed the vial with 1.3 ml of diluent instead of 2.2 ml"; OVERDOSE (hospitalization, medically significant) with onset 07Oct2022, outcome "unknown", 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"; PNEUMONIA (hospitalization, medically significant) with onset 13Oct2022, outcome "not recovered"; RESPIRATORY SYNCYTIAL VIRUS INFECTION (non-serious) with onset 13Oct2022, outcome "not recovered", described as "RSV"; PRODUCT USE ISSUE (hospitalization, medically significant), outcome "unknown", described as "FluZone Sanofi Date: 07Oct22"; BRONCHIOLITIS (medically significant), outcome "unknown", described as "Infiltrate on bronchiolitis"; WHITE BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "High WBC"; ASPARTATE AMINOTRANSFERASE INCREASED (non-serious), ALANINE AMINOTRANSFERASE INCREASED (non-serious), outcome "unknown" and all described as "High AST & ALT". The patient underwent the following laboratory tests and procedures: AST/ALT ratio (0-35): (13Oct2022) 82 uL, notes: Result: High AST& ALT; (13Oct2022) 105 uL, notes: Result: High AST& ALT; Chest X-ray: (13Oct2022) Plus RSV & Pneumonia, notes: Comments: Infiltrate on bronchiolitis; Full blood count (5.0-17.0): (13Oct2022) 20.7, notes: Result: High WBC. Units: Thou/uL; Metabolic function test: (13Oct2022) 20.7, notes: Result: WNL. Units: Thou/uL. Therapeutic measures were taken as a result of pneumonia.  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 (1 is almost 2, 1 patient is 2, 1 patient is 3, 1 patient is 15 months and 1 patient is 6 months) were administered with the vaccine; she stated that it was the last vaccine for 2 of the patients. The nurse made this mistake and sent an email to VAERS but didn't know what she should advise the patient's parents and if they should be worried about anything. On 06Dec2022, it was reported that contributing factors to the medication error was not having appropriate vaccine preparation and administration summary form from CDC website infront of nurse when reconstituting vaccine/not being able to draw up all vaccine doses at one time before administering to patients/nurse fulfilling regular office responsibilities (i.e. rooming patients, taking recording vitals, administering routine vaccines, answering/triaging phone calls, etc.) as well as running covid vaccine clinic alone. covid vaccine did not affect patient(s) condition patient was known to be sick with cough & congestion, which were improving to RN(s) knowledge, prior to receiving vaccine. Patient likely had RSV for 4-5 weeks which progressed into pneumonia independently from vaccine effects, as patient(s) mom did not notify RN of rash which developed the night before patient received covid vaccine. RN would not have given vaccine if aware of rash the night before. The Pfizer product did not had a causal effect to the adverse event. Pertinent details: Mom did not inform office staff patient developed hive on 06Oct2022. Improved at well visit on 06Oct2022 was not on vaccine questionnaire; did not notify RN when asked if patient(s) illness had changed since apt before receiving vaccine. Treated with 1 dose of IV ceftriaxone (600mg), then home with PO amoxicillin, 400mg/5mL; 7.4mL PO q 12h x10 days for pneumonia. Patient hospitalization d/t pneumonia is unrelated to patient receiving covid vaccine.  Follow-up (10Oct2022): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Additional information: reporter phone number.  Follow-up (06Dec2022): This is a spontaneous follow-up report from a contactable nurse. This nurse reported in response to HCP follow-up letter sent that included: Updated information included: Primary reporter suffix added. Primary reporter alternative phone number added. Age at vaccination added. Dose number added. Dose description updated. Route of administration added. Co-suspect added. Co-suspect (vaccination date, lot number, route of administration, dose number, dose description, anatomical location) added. Vaccine administered at private facility added. Other medical history added. Lab tests added. New events added. Event outcomes added.; Sender's Comments: Based on the available information in the case, the causal association between the event Pneumonia, Vaccine overdose, Inappropriate dilution of medication, Drug use for unapproved combination   and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201212961 same reporter/drug/event, different patient;