Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Concussion, Echocardiogram, Electrocardiogram ambulatory, Head injury, Heart rate
Clinical narrative: Passed out cold; Hit her head; Concussion/ concussion symptoms of headache and dizziness; Irregular heart beat rate, some irregularities; This is a spontaneous report received from contactable reporter (a nurse, although she is not currently working as a nurse). The reporter is the parent (patient's mother).  A 15 year-old female patient received BNT162b2, administered in arm left, administration date 21Aug2021 (Lot number: FC3182) at the age of 14 years as dose 2, single and administered in arm left, administration date 31Jul2021 (Lot number: FA7484) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. The patient had no family medical history relevant to adverse events. There were no concomitant medications. No additional vaccines was administered on same date of the pfizer suspect. No other vaccinations were used within four weeks prior to the first administration date of the suspect vaccines. Adverse events following prior vaccinations was none. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 14Nov2021, outcome "recovered with sequelae" (15Nov2021), described as "Passed out cold"; HEAD INJURY (medically significant) with onset 14Nov2021, outcome "recovered" (Nov2021), described as "Hit her head"; CONCUSSION (medically significant) with onset 14Nov2021, outcome "recovered" (Nov2021), described as "Concussion/ concussion symptoms of headache and dizziness"; HEART RATE IRREGULAR (medically significant) with onset 14Nov2021, outcome "recovered" (15Nov2021), described as "Irregular heart beat rate, some irregularities". The events "passed out cold", "hit her head", "concussion/ concussion symptoms of headache and dizziness" and "irregular heart beat rate, some irregularities" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: echocardiogram: (18Nov2021) normal, notes: Patient does not have congenital thing. Everything was fine with her valves; electrocardiogram ambulatory: (18Nov2021) normal, notes: For 48 hours starting 18Nov2021 through 20Nov2021. Patient's rhythm was back to normal sinus rhythm; heart rate: (14Nov2021) irregular. Clinical course: The patient passed out, completely passed out cold for about 2 minutes and hit her head. She had a concussion, irregular heart beat rate, some irregularities. At the time the patient passed out cold mother was talking to the patient. They were down in the basement, had just gone down there because she needed more drawer space; so mother was clearing out a dresser and handed the patient some stuff. While patient was standing there with mother in the basement patient quit talking, and mother looked at the patient and thought "oh my God"; the patient's eyes were wide open and then the patient went down hard, complete loss of consciousness for about 2 minutes; when patient passed out cold patient hit her head on a wooden crate. Patient has never done that before, has never had any health issues. She had eaten, she was doing fine, she was healthy, she was a wrestler before COVID and all this stuff, events just happened out of the blue. Patient was seen in the emergency room on 14Nov2021 related to these events. She was not admitted to the hospital, was under observation; patient didn't even get a room, they had her in the triage room. The emergency room staff did not tell them that day that the patient had an irregular heart beat rate, some irregularities; when they went to the primary doctor's office for follow-up after these events that is when they were told that she had irregular heart beat rate, some irregularities, did not have a normal sinus rhythm on 14Nov2021; Because of that they wanted to make sure everything was fine with her valves so they performed an echocardiogram on 18Nov2021 and had patient wear a holter monitor for 48 hours starting 18Nov2021 through 20Nov2021. The echocardiogram was done just to rule out if she had a congenital thing which she does not; and the holter monitor just to make sure her rhythm was back to normal sinus rhythm which it was. Echocardiogram and holter monitor results were normal, she had normal sinus rhythm and everything was fine with her valves. By 15Nov2021 patient was fine although she still had a headache and dizziness; Headache was still ongoing on 17Nov2021; but mother reported patient recovered completely from the events of hit her head, concussion and concussion symptoms of headache and dizziness within a week or so of onset. She has not had any further events, after these. The case was serious. Causality of all events mother reported as unknown, there's a possibility but she is not sure. Mother reported that she does not know if these events are related to BNT162b2, but events have never happened before; and events did not occur right after she got BNT162b2 doses. During the patient's follow-up appointment at the primary doctor's office the patient saw the Physician Assistant and he did not think events were related to BNT162b2. The Physician Assistant said everything looked normal with the testing they did for patient.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events LOSS OF CONSCIOUSNESS, HEAD INJURY, CONCUSSION, HEART RATE IRREGULAR cannot be excluded  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