Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | LP1776 | — |
The Comirnaty vaccine for ages 12 and above was inadvertently administered to an 11-year-old; The Comirnaty vaccine for ages 12 and above was inadvertently administered to an 11-year-old; fever that lasted for 30 minutes; This is a spontaneous report received from a Nurse from medical information team. An 11-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Feb2025 as dose number unknown, single (Lot number: LP1776, Expiration Date: 26Apr2025) at the age of 11 years for covid-19 immunisation. The patient didn't receive BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA)). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 08Feb2025, outcome "unknown" and all described as "The Comirnaty vaccine for ages 12 and above was inadvertently administered to an 11-year-old"; PYREXIA (non-serious) with onset 2025, outcome "recovered" (2025), described as "fever that lasted for 30 minutes". Additional information: Inadvertent administration of higher than the recommended dose of 10 mcg in 5 through 11 years of age. The reporter stated the mother of the patient or the parent of the patient reported that after the injection the patient experienced fever that lasted for 30 minutes.