Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypertension, Malaise, Palpitations, Pericardial effusion
Clinical narrative: pericardial effusions; Increased palpitations; Increase in psoriasis spots; High blood pressure; Felt like a ton of bricks were in her body/Body felt so heavy; Not feeling well, exhausted; Not feeling well, exhausted; Shortness of breath; Chest pain; pericarditis; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Batch/Lot number: unknown) at the age of 45  as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Diagnosed since she was a teenager, Had for 30 years or more; "Psoriasis" (unspecified if ongoing); "Palpitations" (unspecified if ongoing); "allergies" (unspecified if ongoing). Concomitant medication(s) included: COLCHICINE. The following information was reported: PERICARDITIS (medically significant) with onset 2021, outcome "recovered", described as "pericarditis"; PERICARDIAL EFFUSION (medically significant), outcome "unknown", described as "pericardial effusions"; MALAISE (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "recovered" and all described as "Not feeling well, exhausted"; DYSPNOEA (non-serious) with onset 2021, outcome "recovered", described as "Shortness of breath"; CHEST PAIN (non-serious) with onset 2021, outcome "recovered", described as "Chest pain"; PALPITATIONS (non-serious), outcome "recovered", described as "Increased palpitations"; PSORIASIS (non-serious), outcome "not recovered", described as "Increase in psoriasis spots"; HYPERTENSION (non-serious), outcome "recovering", described as "High blood pressure"; DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Felt like a ton of bricks were in her body/Body felt so heavy". The patient underwent the following laboratory tests and procedures: angiogram: (unspecified date) unknown, notes: Had the CTA last month; blood pressure abnormal: (unspecified date) 180/100; (unspecified date) 130-140, notes: blood pressure ranges from 130-140s / mid-upper 80-90s; cardiac stress test: (25Jun2021) unknown; echocardiogram: (25Jun2021) unknown, notes: trivial pericardial effusions adjacent to right ventricle; (01Oct2021) unknown, notes: Pericardial effusion is minimal at this time; electrocardiogram: (17Jun2021) unknown. Therapeutic measures were taken as a result of pericarditis, malaise, fatigue, chest pain. The patient took COVID Vaccine to stop the spread. Caller believes date of COVID vaccine was 17May2021, but it may be sooner than that. She confirms the dose was given in May2021. Patient doctor doesn't want to put her on anything to decrease her immune system now. Was not on Amlodipine prior to COVID vaccine. Did not have high blood pressure before COVID vaccine. Time the vaccination was given early morning between 9 to 10 AM.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case provided, the causal association between the event pericarditis, pericardial effusion and the suspect drug BNT162B2 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.