Received Feb 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA4459 | OT / LL |
inadvertently gave a Pfizer 12 plus vaccine (the Comirnaty) to a two year old patient; Fever; fussy; diarrhea; possible confusion episode; fussy; inadvertently gave a Pfizer 12 plus vaccine (the Comirnaty) to a two year old patient; This is a spontaneous report received from a Nurse from medical information team. A 2-year-old female patient (unknown if pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 10Feb2026 at 15:45 as dose 1, 0.3 ml, single (Lot number: NA4459, Expiration Date: 29Jul2026) at the age of 2 years intramuscular, in left thigh for covid-19 immunisation. The patient's relevant medical history included: "snoring" (unspecified if ongoing). Concomitant medication(s) included: FLULAVAL, on 10Feb2026 as dose 4, single; VITAMIN D [VITAMIN D NOS]. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 10Feb2026 at 15:45, OVERDOSE (non-serious) and all described as "inadvertently gave a Pfizer 12 plus vaccine (the Comirnaty) to a two year old patient"; PYREXIA (non-serious) with onset 12Feb2026, described as "Fever"; DIARRHOEA (non-serious) with onset 12Feb2026, described as "diarrhea"; PAIN (non-serious), IRRITABILITY (non-serious) all with onset 12Feb2026 and all described as "fussy"; CONFUSIONAL STATE (non-serious) with onset 12Feb2026, described as "possible confusion episode". The event "inadvertently gave a pfizer 12 plus vaccine (the comirnaty) to a two year old patient" required physician office visit. Therapeutic measures were not taken as a result of pyrexia, pain, diarrhoea, confusional state, irritability. Additional information: NDC: 0069-2528-10. She is taking Vitamin D. looking at her history. Reporter do not see anything. She had a little bit of snoring marked on her face sheet for medical conditions. Reporter stated, she had not done anything in the last 2 weeks. They had actually not seen her since September 2025. On 19Feb2026, it was reported that the patient came back in 12Feb2026 for fevers, fussy, pain, and diarrhea. The patient was also with possible confusion, but it resolved. Follow-up (11Feb2026): This is a follow-up report received from a Nurse from medical information team. Updated information: relevant medical history, patient information, concomitant medications, dosage, route of administration, lot number and expiration date of suspect drug. Follow-up (19Feb2026): This is a follow-up report received from a Nurse from medical information team. Updated information: new events added, concomitant medication information updated, patient information updated. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.
Medical History/Concurrent Conditions: Snoring
VITAMIN D [VITAMIN D NOS]