Received Feb 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | LP1776 | IM / LL |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | LP1776 | OT |
fever; Pfizer COVID-19 vaccine for 12 years and plus administered to a child that was 1-year-old; Pfizer COVID-19 vaccine for 12 years and plus administered to a child that was 1-year-old; This is a spontaneous report and received from Other HCPs from medical information team, Program ID:. A 12-month-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Jan2025 as dose 2, single (Lot number: LP1776, Expiration Date: 25Feb2025) at the age of 12 months intramuscular, in left leg for covid-19 immunisation, Device Lot Number: LP1776, Device Expiration Date: 26Apr2025. The patient's relevant medical history included: "Developmental delay", start date: 16Jul2024 (unspecified if ongoing); "Motor delay", start date: 17Jul2024 (unspecified if ongoing); "Autism", start date: 19Nov2024 (unspecified if ongoing). Concomitant medication(s) included: FLUZONE [INFLUENZA VACCINE] taken for immunisation, on 13Jan2025 as dose 2, single. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 13Jan2025, outcome "unknown" and all described as "Pfizer COVID-19 vaccine for 12 years and plus administered to a child that was 1-year-old"; PYREXIA (non-serious) with onset 14Jan2025, outcome "recovered", described as "fever". The event "fever" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of overdose, product administered to patient of inappropriate age, pyrexia. Additional Information: A medical assistant calling for recommendations for two immunizations of Pfizer COVID-19 vaccine for 12 years and plus (NDC Number: 0069-2432-10) that were given, one administered to a child that was 1-year-old. The wrong one was pulled. They wanted to know what to expect or what to do. Further, the patient had a CBC drawn in a leg on 13Jan2025. The patient got the flu shot (NDC Number: 4928142450) too. The patient did not take any other medications within 2 weeks prior to event onset and the patient did not receive any other vaccines within 4 weeks prior to the administration of the suspect vaccine. Inadvertent human error reported. The patient did not experience any adverse events as a consequence of the error. No emergency room visit required. Follow-up (13Jan2025): This is a spontaneous follow-up report received from a healthcare professional from medical information team, Program ID:. Updated Information: reporter information, suspect product information, medical history information, concomitant product, patient information, and course of events. Follow-up (10Feb2025): This is a spontaneous follow-up report received from a healthcare professional from medical information team, Program ID:. Updated Information: reporter details (clinical supervisor), suspect product information, medical history information, concomitant product, patient information, and reaction data ("Fever" added as additional adverse event).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500007753 Same reporter, drug, and event; different patient;
Medical History/Concurrent Conditions: Autism; Developmental delay; Motor developmental delay
FLUZONE [INFLUENZA VACCINE]
Test Date: 20250113; Test Name: CBC; Result Unstructured Data: Test Result:Unknown results