Received Feb 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 5 | LP1776 | IM / RL |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | LP1776 | OT / RA |
fever; gave COMIRNATY COVID vaccine to a 1 and 3 year old; gave COMIRNATY COVID vaccine to a 1 and 3 year old; This is a spontaneous report and received from Other HCPs from medical information team, Program ID:. A 3-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Jan2025 as dose 1, single (Lot number: LP1776, Expiration Date: 25Feb2025) at the age of 3 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Autism", start date: 19Nov2024 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 immunisation. 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 "gave COMIRNATY COVID vaccine to a 1 and 3 year old"; PYREXIA (non-serious) with onset 15Jan2025, outcome "recovered", described as "fever". The event "fever" required physician office visit. Therapeutic measures were not taken as a result of pyrexia, overdose, product administered to patient of inappropriate age. Additional information: The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient was not taking any other medications within 2 weeks prior to the event onset. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. It was reported that the medication error occurred when the product was prepared, dispensed and administered to the patient. Misunderstanding of instructions by the individual administering the medication was a factor considered to be responsible for the medication error. Follow-up (13Jan2025): This is a spontaneous follow-up report received from an Other HCP from medical information team, Program ID:. Updated information: reporter details updated. Follow-up (10Feb2025): This is a spontaneous follow-up report received from an Other HCP. Updated information: relevant medical history, historical vaccine details, suspect vaccine details (lot number, expiration date, vaccination date, route of vaccination, anatomical location), vaccine facility information, new event (fever).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500007655 Same reporter/drug/event, different patient;
Medical History/Concurrent Conditions: Autism