Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Gave the vaccine to 11 months old child that should have been meant for an 11 years old child; Blue cap given to a person who was supposed to receive the yellow cap; Gave the vaccine to 11 months old child that should have been meant for an 11 years old child; Blue cap given to a person who was supposed to receive the yellow cap; Low grade fever; This is a spontaneous report received from contactable reporter(s) (Pharmacist), Program ID.  An 11-month-old female patient received bnt162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), on 20Nov2023 at 16:30 as dose number unknown, 0.3 ml single (Lot number: HE2391, Expiration Date: 30Apr2024) at the age of 11 months, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Nov2023, outcome "unknown", described as "Low grade fever"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 20Nov2023 at 16:30, outcome "unknown" and all described as "Gave the vaccine to 11 months old child that should have been meant for an 11 years old child; Blue cap given to a person who was supposed to receive the yellow cap".  Additional information: Transferring agent stated, "I have a pharmacist on phone, and she had an incident regarding COVID pediatric vaccine and they gave the vaccine to 11 months old child that should have been meant for an 11 year old child. The vaccine was meant for 11-year-old child, and they give it to the wrong age person." When paraphrased the concern, reporter stated, "Yes, it was a Blue cap given to a person who was supposed to receive the yellow cap."  First time calling regarding this concern, reporter stated, "No, I have not. I have not called before, and it is yesterday, and we called, and it was closed. So, I am just calling up to see first time and see what to tell the mama of the child who received the vaccine." Product details: When probed if the vaccination card is handy, reporter stated, "Vaccination card no, I have just the, they just showed the Pharmacy one time and it was one dose that they gave. I do not have record of the previous doses or other. Correct, I do not have the vaccination card." Date of Vaccination: Reporter stated, "November 20, 2023, yesterday." When probed to clarify the name of vaccine, reporter stated, "Yes, it is the Pfizer BioNTech COVID vaccine the blue cap." Previous immunization with Pfizer Vaccine: reporter stated, "No it was not. It was the only vaccine that they received at this Pharmacy." Any vaccine administered on same date: Reporter stated, "No." As of 27Nov2023, Reporter on the line who initially stated she was calling about the Covid Vaccine yellow cap, 6 months to 5 year. Pfizer BioNtech, 2023-2024 formula. There was a case where the wrong dose was given to patient. She called few days ago and reported this information. Reporter clarified the wrong dose as the patient was 11 months old and they got the blue cap of the Pfizer Covid Vaccine 5 to 12 years old instead of the yellow cap. They are reaching back out now to see what to tell the patient's mom to expect. Informed the patient's mom probably more side effects since it was a higher dose, but following up to see if anything else to be concerned with. There was no other Vaccine administered on the same day with the Pfizer vaccine. NDC number of BioNTech COVID-19 Vaccine: 59267-4331-2.  Follow up (27Nov2023): This is a spontaneous follow up report received from a contactable Pharmacist.  Updated information included:  clinical course.  Follow up (27Nov2023): This is a spontaneous follow up report received from a contactable Pharmacist. Updated information included:  Product data (expiration date and Anatomical Location updated); Reaction data (new event Low grade fever).