Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Hyperventilation, Off label use, Product use issue, Syncope
Clinical narrative: slumped over to the left and hit the side of his head; syncopal/near-syncopal episode; BP was 98/42; Flulaval quadrivalent given on 11Oct2022; Flulaval quadrivalent given on 11Oct2022; he felt "really weird" and that it was like he "was in a dream"; crying; Hyperventilating; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 9-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2022 as dose 3 (orange cap; booster), 0.2 ml single (Lot number: FT1551, Expiration Date: 30Nov2022) at the age of 9 years intramuscular for covid-19 immunisation; influenza vaccine inactive split 4v (FLULAVAL QUADRIVALENT), on 11Oct2022 as dose number unknown, single (Lot number: 9249L, Expiration Date: 30Jun2023) intramuscular for immunisation. The patient's relevant medical history included: "Nervous" (unspecified if ongoing). The patient concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunization.  The following information was reported: BLOOD PRESSURE DIASTOLIC DECREASED (medically significant) with onset 11Oct2022, outcome "recovering", described as "BP was 98/42"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 11Oct2022, outcome "unknown" and all described as "Flulaval quadrivalent given on 11Oct2022"; HYPERVENTILATION (non-serious) with onset 11Oct2022, outcome "unknown", described as "Hyperventilating"; CRYING (non-serious) with onset 11Oct2022, outcome "unknown"; FEELING ABNORMAL (non-serious) with onset 11Oct2022, outcome "unknown", described as "he felt "really weird" and that it was like he "was in a dream"; FALL (medically significant) with onset 11Oct2022, outcome "unknown", described as "slumped over to the left and hit the side of his head"; SYNCOPE (medically significant) with onset 11Oct2022, outcome "unknown", described as "syncopal/near-syncopal episode". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 120/90, notes: BP initially was 120/90 shortly; 98/42, notes: BP was 98/42; Heart rate: 88, notes: Heart rate 88.  The clinical course of the events was reported as follows: Pfizer COVID-19 mRNA L, NP-S PF 5-11 Y peds use for COVID-19 under Emergency use Authorization (EUA): Pfizer COVID-19 mRNA LNP-S PF (Pfizer 0.2ml 5-11 Y Peds-orange cap) (name withheld) was in the office yesterday afternoon, 11Oct2022, for his COVID booster and influenza Vaccine. He has tolerated all vaccines well in the past. Nurse noted that he was a little nervous prior to getting the vaccines but the administration of the vaccines was unremarkable. The patient, sister, and dad were sent to the waiting room to wait 15minutes. I was in my office and heard commotion and hollering for help in the waiting room. When I arrived, the patient was sitting on the floor with some other helpers around him, and he was crying. He apparently had been sitting near dad when he slumped over to the left and hit the side of his head on the chair next to him. He quickly came to, dad reports that he was out for less than a second, and then started crying and hyperventilating. (Name withheld) reported that he felt really weird and that it was like he was in a dream. Several nurses, MAs, and staff members were present and helping with getting him laying down, applying a cool cloth and fan, and taking vitals, BP initially was 120/90 shortly after the syncopal/near-syncopal episode, Heart rate 88, regular. After resting for 15 minutes and calming down, BP was 98/42, Patient remained in the waiting room with family and was able to leave without further incident after staying for another 15 minutes. He reported feeling fine at that time. The chart note was placed in the Immunization Record from 11Oct2022.  No Follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events  BLOOD PRESSURE DIASTOLIC DECREASED, Syncope and Fall.  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.