Age: 1.75
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered without diluent; administered without diluent; Dose 3rd Date: 10Jul2023, Dose 2nd Date: 04May2023; 101 fevers; fussiness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 21-month-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Jul2023 at 14:00 as dose 3 (maroon cap; booster), 0.2 ml single (Lot number: GY5673, Expiration Date: 26Jul2023) at the age of 21 months intramuscular, in right thigh for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1 (MAROON CAP) SINGLE, Time (24hr): 08:37 am, Anatomical site of injection: thigh, left, Route of Administration: Intramuscular, Batch/Lot number: FX5095), administration date: 06Apr2023, when the patient was 18-month-old, for COVID-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 2 (MAROON CAP) SINGLE, Time (24hr): 15:52, Anatomical site of injection: thigh, left, Route of Administration: Intramuscular, Batch/Lot number: GP4345), administration date: 04May2023, when the patient was 19-month-old, for COVID-19 immunization. The following information was reported: PYREXIA (medically significant) with onset 10Jul2023, outcome "recovered", described as "101 fevers"; IRRITABILITY (medically significant) with onset 10Jul2023, outcome "recovered", described as "fussiness"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 10Jul2023 at 14:00, outcome "unknown", described as "Dose 3rd Date: 10Jul2023, Dose 2nd Date: 04May2023"; OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 10Jul2023 at 14:00, outcome "unknown" and all described as "administered without diluent". The events "101 fevers" and "fussiness" required physician office visit. The patient underwent the following laboratory tests and procedures: Body height: 31 inches; Body temperature: 101 Fahrenheit; Weight: 24 lbs. Therapeutic measures were taken as a result of pyrexia, irritability.  Additional information: The reporter was asking for guidelines for Pfizer Covid-19 Vaccine that was administered without the diluent. The reporter was calling regarding the 6 months-5 years of age bivalent Pfizer Covid-19 vaccine. She stated the vaccine was administered to a 1 year and 9 month old female without diluent, and asked for our recommendations/guidelines. There were no lab tests within two weeks. Patient did not receive prior vaccine (4 weeks prior). NDC number of COVID 19 Bivalent Vaccine: 5926706091. Dose: Reporter stated, "0.2ml but it was not diluted." Manufacture date rather Feb2023. The patient provided information to the reporter regarding the reported adverse event with use of the product and the reporter considered the Pfizer product had a causal effect to the adverse event.  Follow-up (10Jul2023): This is a spontaneous follow-up report received from the same contactable Other HCP. This Other HCP reported for a patient that:  Updated information included: Primary reporter mailing address added. Patient (Initials, DOB, Age at vaccination, Race, Weight, Height) added. RMH none added. Suspect vaccine recoded and (Dose, Lot number, Route of administration, Expiry date and Anatomical location) added. Facility information added. Concomitant therapy captured as None.  Follow-up (31Jul2023): This is a spontaneous follow-up report received from same contactable other-HCP. This other-HCP reported in response to HCP letter sent that included: Updated information included: Reporter information, patient details (historical vaccination, lab data added), suspect product details (start date and stop date, dose number, anatomical location, vaccination facility and type added), event information (onset date added and Causality updated to 'Related' for events 'Overdose' and 'Product concentrate not diluted,  New events '101 fevers' 'fussiness' was added).; Sender's Comments: Based on the information provided in this case and considering a plausible drug-event temporal association, there is a reasonable possibility that the reported events of Pyrexia and Irritability are related to the suspect product BNT162b2 (COMIRNATY).,Linked Report(s) : US-PFIZER INC-PV202300133334 same patient/vaccine, different vaccine dose/event;