Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Body temperature, Body temperature abnormal, Chest discomfort
Clinical narrative: She is in remission from Systemic Jia for 1 year 7 months; Migraines; Stomach pains; Vomiting; Flushed skin; Temperature fluctuations from 99.4 to 95.0 quickly with migraines; Shivering; Chest discomfort and racing heart; Chest discomfort and racing heart; Felt out of breath; Extreme Leg pain from high thighs to ankles lasted 24 hours with moderate for the next 5-7 days.; Diagnosed with PEG allergy; Fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 10-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 10:00 (Lot number: Fh8028) at the age of 10 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Systemic Jia" (unspecified if ongoing), notes: Systemic Jia; "Macrophage Activation Syndrome" (unspecified if ongoing), notes: Macrophage Activation Syndrome both in remission; "Known allergy: Nsaids" (unspecified if ongoing), notes: Known allergy: Nsaids; "Known allergy: Possible wheat allergy" (unspecified if ongoing), notes: Known allergy: Possible wheat allergy; "Known allergy: adhesives" (unspecified if ongoing), notes: Known allergy: adhesives; "Known allergy: contrast" (unspecified if ongoing), notes: Known allergy: contrast. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The patient received Zyrtec as pre-treatment for possible reactions within two weeks of vaccination. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fl0007, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 07Nov2021, when the patient was 10 years old, for COVID-19 immunization, reaction(s): "Vomiting", "flushed cheeks", "Fatigue", "Migraines". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was neither diagnosed with COVID-19 Prior to vaccination, nor been tested for COVID-19 Since the vaccination. The following information was reported: STILL'S DISEASE (medically significant) with onset 2021, outcome "recovering", described as "She is in remission from Systemic Jia for 1 year 7 months". Now 4 months out things have been started to spread out. MIGRAINE (non-serious) with onset 2021, outcome "not recovered", described as "Migraines"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "not recovered", described as "Stomach pains"; VOMITING (non-serious) with onset 2021, outcome "recovering", described as "Vomiting/Extreme vomiting"; FLUSHING (non-serious) with onset 2021, outcome "not recovered", described as "Flushed skin"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 2021, outcome "recovering", described as "Temperature fluctuations from 99.4 to 95.0 quickly with migraines"; CHILLS (non-serious) with onset 2021, outcome "recovering", described as "Shivering"; CHEST DISCOMFORT (non-serious), PALPITATIONS (non-serious) all with onset 2021, outcome "recovering" and all described as "Chest discomfort and racing heart"; DYSPNOEA (non-serious) with onset 2021, outcome "recovering", described as "Felt out of breath"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "Extreme Leg pain from high thighs to ankles lasted 24 hours with moderate for the next 5-7 days."; POLYMERS ALLERGY (non-serious) with onset 2021, outcome "recovering", described as "Diagnosed with PEG allergy"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Fatigue". The events "she is in remission from systemic jia for 1 year 7 months", "migraines", "stomach pains", "vomiting", "flushed skin", "temperature fluctuations from 99.4 to 95.0 quickly with migraines", "shivering", "chest discomfort and racing heart", "chest discomfort and racing heart", "felt out of breath", "extreme leg pain from high thighs to ankles lasted 24 hours with moderate for the next 5-7 days." and "diagnosed with peg allergy" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) slight fluctuations, notes: Bloodwork done 3 times and only very slight fluctuations; body temperature: (08Nov2021) 99.4 to 95.0, notes: temperature fluctuations; echocardiogram: (unspecified date) unknown result; heart rate: (08Nov2021) racing, notes: racing heart; magnetic resonance imaging: (unspecified date) unknown result. Therapeutic measures were not taken as a result of still's disease, migraine, abdominal pain upper, vomiting, flushing, body temperature abnormal, chills, chest discomfort, palpitations, dyspnoea, pain in extremity, polymers allergy, fatigue.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events due to temporal relationship. 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.