Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: spiked a fever over the weekend after receiving that large dose; Comirnaty for 12 year and above was inadvertently given instead of the Pfizer BioNTech for 6 months to 4 years to their 2-year-old female patient/inadvertently administered the adult dose; Comirnaty for 12 year and above was inadvertently given instead of the Pfizer BioNTech for 6 months to 4 years to their 2-year-old female patient/inadvertently administered the adult dose; This is a spontaneous report received from a Nurse from medical information team.  A 2-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Oct2024 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 2 years intramuscular, in left thigh for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (medically significant), OVERDOSE (medically significant) all with onset 04Oct2024, outcome "recovered" and all described as "Comirnaty for 12 year and above was inadvertently given instead of the Pfizer BioNTech for 6 months to 4 years to their 2-year-old female patient/inadvertently administered the adult dose"; PYREXIA (medically significant) with onset 05Oct2024, outcome "recovered" (Oct2024), described as "spiked a fever over the weekend after receiving that large dose". Clinical course: The reporter dialed in to inquire for recommendations because the Comirnaty for 12 year and above was inadvertently given instead of the Pfizer BioNTech for 6 months to 4 years to their 2-year-old female patient. Also, the caller stated that the given product was Comirnaty 2024-2025 formula but the intended product and what should have been given to the patient was the Biontech covid-19 vaccine 2024-2025 formulation for ages 6 months to less than 5 years old. In the immediate action she needs to notify the patient that the incorrect dose was given and advise on if there is anything to be aware of. She is calling to ask about what to advise when she calls to inform on the patient. On 10Oct2024, it was reported that the patient was inadvertently administered the adult dose for the Comirnaty vaccine for age 12 plus and the patient is age 2 years old.  The vaccine was administered on Friday 04Oct2024. Caller stated she has the insert in front of her and it is for the Comirnaty vaccine for age 12 plus that this patient received. The reporter considered the event as medically significant. They have followed this patient closely and the patient is a baby, and the baby spiked a fever over the weekend after receiving that large dose and she does not know if any anti-pyretic was needed. The fever began on 05Oct2024 and did resolve and the caller does not know the date it resolved but did check with the patient's mom on Tuesday 080ct202 who said the baby was doing well. The caller is curious now that this was reported to the company and patient of course are there any other steps to report this missed medication error. The patient should have received lot LN6739 instead.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.  Follow-up (10Oct2024): This is a spontaneous follow-up report received from same nurse: Updated information: patient details (initials, date of birth, height, age at vaccination, weight, race), suspect drug data (dosing regimen, therapy date, anatomical; location), reaction data (event added) clinical course. Case upgraded as serious.; Sender's Comments: Based on known drug safety profile, and plausible temporal association the event pyrexia is assessed as related to the suspect drug BNT162B2 OMICRON (KP.2) but consider also possible contributory effects from the overdose of the suspect drug the patient was given. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.