Age: 47.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Off label use, Product use issue, Scan myocardial perfusion
Clinical narrative: A. Fib; diastolic BP is abnormally high; other vaccine same date product=Flu Shot; other vaccine same date product=Flu Shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 04Oct2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "degenerative disc disease" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: METHOCARBAMOL; BUSPIRONE; PERCOCET [OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE; PARACETAMOL]; OMEPRAZOLE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 04Oct2022, outcome "unknown" and all described as "other vaccine same date product=Flu Shot"; ATRIAL FIBRILLATION (medically significant) with onset 12Oct2022, outcome "not recovered", described as "A. Fib"; BLOOD PRESSURE INCREASED (medically significant) with onset 12Oct2022, outcome "not recovered", described as "diastolic BP is abnormally high". The events "a. fib" and "diastolic bp is abnormally high" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure diastolic: (12Oct2022) abnormally high (110+); Electrocardiogram: (15Sep2022) normal sinus rhythm; (11Oct2022) A. Fib; prelabs: (11Oct2022) A. Fib; Scan myocardial perfusion: (unspecified date) Unknown results. Therapeutic measures were taken as a result of atrial fibrillation, blood pressure increased. Clinical Course: It was reported that other vaccine in four weeks: No. If covid prior vaccination: Yes. If covid tested post vaccination: No. Known allergies: No. On 15Sep2022 at a local ER patient had an EKG with a normal sinus rhythm (I have never had anything but a normal sinus rhythm). On 04Oct2022, patient received the Bivalent Covid-19 booster shot. One week later on 11Oct2022 patient was having prelabs and EKG for an upcoming surgery. They checked 3 times and patient was in A. Fib. Since that time every EKG has shown me in A. Fib. Also, now my diastolic BP was abnormally high (110+), and patient was put on BP medications. Patient had never had any cardiac issue in my life and now am scheduled for a cardioeversion and was told to expect to need a cardio ablation in the future. Patient also been put on blood thinners to prep for the cardioeversion.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.