Age: 10.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Nasal congestion, Off label use, Overdose, Pain, Product administered to patient of inappropriate age
Clinical narrative: fever; body aches; congestion; He got the flu shot today as well; He got the flu shot today as well; medical assistant reporting that a 10-year-old patient received the adult dose of Pfizer COVID vaccine bivalent for the booster dose.; medical assistant reporting that a 10-year-old patient received the adult dose of Pfizer COVID vaccine bivalent for the booster dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 10-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 4 (booster), single (Lot number: GH9697, Expiration Date: 30Jun2023) at the age of 10 years intramuscular, in left deltoid for covid-19 immunisation; influenza vaccine inact split 3v (FLULAVAL), on 31Oct2022 as dose number unknown, single (Lot number: 72KJ4, Expiration Date: 30Jun2023) for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1;  unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2;  unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3;  unknown manufacturer), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 31Oct2022, outcome "unknown" and all described as "He got the flu shot today as well"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 31Oct2022, outcome "unknown" and all described as "medical assistant reporting that a 10-year-old patient received the adult dose of Pfizer COVID vaccine bivalent for the booster dose."; PAIN (non-serious) with onset 01Nov2022, outcome "recovered", described as "body aches"; NASAL CONGESTION (non-serious) with onset 01Nov2022, outcome "recovered", described as "congestion"; PYREXIA (non-serious) with onset 01Nov2022, outcome "recovered", described as "fever". Therapeutic measures were not taken as a result of pyrexia, pain, nasal congestion.  Additional information: Caller was a medical assistant reported that a 10-year-old patient received the adult dose of Pfizer COVID vaccine bivalent for the booster dose. The caller wanted to know if it was safe for the patient. This report was not related to study or program. Other conditions and investigations reported as no. The patient received the adult dose bivalent formulation that was intended for the patient booster dose. The patient did not receive any treatment. Reporter stated, the patient got the vaccine here in the office, doctor's office. Any prior vaccination (within 4 weeks) reporter stated, he got the flu shot today as well. The patient did not received any other vaccine prior, no medical history and no relevant test performed. There was no hospitalization and no specific relevant test for thromboembolic events with thrombocytopenia.  Follow-up attempts are completed. No further information is expected.  Follow up (23Nov2022): This is a spontaneous follow-up report from a contactable consumer. This consumer reported in response to Non Hcp follow-up letter sent which Included that: Updated information included: Patient information (last name, Address, city, state and postal code) added. Historical vaccine (dose 01, 02 and 03). Vaccination Information (dose number, dose description, Route of administration, Anatomical Location) added. Vaccine Administered at Facility captured. New events (Fever, body aches, congestion). Concomitant Therapy.