Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Laboratory test abnormal, Ocular discomfort, Pericarditis, Pyrexia
Clinical narrative: recent diagnosed with pericarditis; feeling hot and weird; I took his temp 103Ax, BP 165/120; I took his temp 103Ax, BP 165/120; blood pressure has been in the 130-140s; droopy eyes; weird; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 15-year-old male patient received BNT162b2 (BNT162B2), on 02Jul2021 at 17:00 as dose 2, single (Lot number: ER8736) at the age of 15 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: BNT162b2 (Prev dose lot number: Pfizer EW01765, prev dose administration time: 05:00 PM , prev dose dose number: 1, prev dose vaccine location: Left arm), administration date: 11Jun2021, when the patient was 15-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), LABORATORY TEST ABNORMAL (non-serious) all with onset 03Jul2021, outcome "recovered" and all described as "I took his temp 103Ax, BP 165/120"; BLOOD PRESSURE INCREASED (non-serious) with onset 03Jul2021, outcome "recovered", described as "blood pressure has been in the 130-140s"; OCULAR DISCOMFORT (non-serious) with onset 03Jul2021, outcome "recovered", described as "droopy eyes"; FEELING HOT (non-serious) with onset 03Jul2021, outcome "recovered", described as "feeling hot and weird"; FEELING ABNORMAL (non-serious) with onset 03Jul2021, outcome "recovered", described as "weird"; PERICARDITIS (medically significant), outcome "unknown", described as "recent diagnosed with pericarditis". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 165/120, notes: I took his temp 103Ax, BP 165/120; 130-140, notes: My son(s) systolic blood pressure has been in the 130-140s; 116, notes: prior to covid vaccine systolic bp was 116; Body temperature: 103, notes: took his temp 103Ax, BP 165/120; Heart rate: Normal, notes: HR normal range; Vital signs measurement: decreased to normal less than 30 minutes, notes: Vital sign decreased to normal less than 30 minutes. Therapeutic measures were taken as a result of feeling hot, pyrexia, laboratory test abnormal, blood pressure increased, ocular discomfort, feeling abnormal.  Clinical  information: Facility type vaccine was pharmacy or Drug Store. If other vaccine in four weeks was no. Other medications in two weeks was Albuterol MDI. Approximately 16 hours post 2nd vaccine my son complaint of feeling hot and weird, droopy eyes, I took his temp 103Ax, BP 165/120, HR normal range. I immediately applied an ice pack to the back of his neck and gave Tylenol. Vital sign decreased to normal less than 30 minutes. For 3 days this happened. My sons systolic. blood pressure has been in the 130-140s; prior to covid vaccine systolic bp was 116. Adverse event start date was 03Jul2021.  If patient recovered was recovered. If treatment ae was Yes. Ae treatment was home treatment, monitoring, Tylenol and ice pack. If covid prior vaccination was yes. If covid tested post vaccination was No. Other medical history was Asthma, recent diagnosed with pericarditis; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Pericarditis  which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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.