Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Heart arrhythmia as well; pain in heart/chest area; feeling extreme fatigue; swelling; pain in heart/chest area; numbness in mouth; sweating; No fever but hard to have a full breath in; muscle pain; low fever; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Jan2022 09:00 (Lot number: FJ1614) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hepatitis B" (unspecified if ongoing). Concomitant medication(s) included: TENOFOVIR; VITAMIN D3; VITAMIN E [TOCOPHEROL]; VITAMIN B12 [CYANOCOBALAMIN]; ACETAMINOPHEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot Number: EL3248, Vaccine location: Right arm), administration date: 20Apr2021, when the patient was 36 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Lot Number: EL3248, Vaccine location: Arm Left), administration date: 30Mar2021, when the patient was 36 years old, for Covid-19 immunization. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other vaccine in four weeks. The following information was reported: IMMUNISATION (medically significant) with onset 10Jan2022 09:00, outcome "unknown", described as "Booster"; ARRHYTHMIA (medically significant) with onset 12Jan2022 08:00, outcome "not recovered", described as "Heart arrhythmia as well"; ANGINA PECTORIS (medically significant), CHEST PAIN (non-serious) all with onset 12Jan2022 08:00, outcome "not recovered" and all described as "pain in heart/chest area"; MYALGIA (non-serious) with onset 11Jan2022, outcome "not recovered", described as "muscle pain"; PYREXIA (non-serious) with onset 11Jan2022, outcome "not recovered", described as "low fever"; FATIGUE (non-serious) with onset 12Jan2022 08:00, outcome "not recovered", described as "feeling extreme fatigue"; SWELLING (non-serious) with onset 12Jan2022 08:00, outcome "not recovered", described as "swelling"; HYPOAESTHESIA ORAL (non-serious) with onset 12Jan2022 08:00, outcome "not recovered", described as "numbness in mouth"; HYPERHIDROSIS (non-serious) with onset 12Jan2022 08:00, outcome "not recovered", described as "sweating"; DYSPNOEA (non-serious) with onset 12Jan2022 08:00, outcome "not recovered", described as "No fever but hard to have a full breath in". Therapeutic measures were not taken as a result of arrhythmia, angina pectoris, myalgia, pyrexia, fatigue, swelling, chest pain, hypoaesthesia oral, hyperhidrosis, dyspnoea.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the events booster,   Arrhythmia,  Angina pectoris  and 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.