Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Ischaemia, Ventricular extrasystoles
Clinical narrative: ventricular premature complex on their EKG; abnormal T wave with ischemia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; LOSARTAN taken for hypertension; OMEPRAZOLE. Past drug history included: Lisinopril, reaction(s): "high blood pressure". Vaccination history included: coviD-19 vaccine (Dose Number: 01, Dose: Unknown, Site: Unknown, Batch/Lot number: Unknown, Pharmaceutical form (Dosage form): Injection, Manufacturer: Unknown), administration date: 26Mar2021, for COVID-19 protection, reaction(s): "the patient's EKG showed ventricular premature complex and had a abnormal EKG"; coviD-19 vaccine (Dose Number: 02, Manufacturer: Unknown), administration date: 13Jan2022, for COVID-19 Immunization; coviD-19 vaccine (Dose Number: 03, Manufacturer: Unknown), administration date: 16Apr2022, for COVID-19 Immunization. The following information was reported: ISCHAEMIA (medically significant) with onset 07Feb2023, outcome "not recovered", described as "abnormal T wave with ischemia"; VENTRICULAR EXTRASYSTOLES (medically significant), outcome "not recovered", described as "ventricular premature complex on their EKG". The patient underwent the following laboratory tests and procedures: Electrocardiogram: (unspecified date) ventricular premature complex, notes: Result: ventricular premature complex; Unit: Not Provided; (unspecified date) ventricular premature complex, notes: the patient's EKG showed ventricular premature complex; (unspecified date) abnormal, notes: had a abnormal EKG; (unspecified date) Normal, notes: All previous EKG's prior to the first Covid-19 vaccine were normal; (07Feb2023) abnormal T wave with ischemia, notes: Result: abnormal T wave with ischemia; Unit: Not Provided.  Clinical course: Other Conditions were Unknown. Patient was on Lisinopril and was switched Losartan at a unknown date. The reporter indicated that the doctor switched the patient to Losartan because of their high blood pressure which was new. The switch had to do with the patients high blood pressure. No NDC, Lot, or expiration date was provided for the Lisinopril. Caller has no details to provide for the Losartan, Simvastatin, and Omeprazole for the report. Call received from a Pfizer Education Rep calling about the COVID-19 Bivalent Vaccine, unknown cap color. The COVID-19 Bivalent Vaccine was given at Withheld 6 weeks ago and was given to a 65-year-old male. The patient did not bring in their vaccine card and they were not sure what specific cap color for the medication, but clarified that it was the Pfizer COVID-19 bivalent vaccine. The patient originally had a COVID-19 vaccine on 26Mar2021, unknown manufacturer. They had another COVID-19 vaccine on 13Jan2022, Unknown manufacturer. The patient had a 3rd COVID-19 vaccine on 16Apr2022, unknown manufacturer. The most recent COVID-19 Vaccine was the Pfizer COVID-19 Bivalent Vaccine and was given 6 weeks ago, exact date unknown, it was not recorded by the doctors office as the patient did not have their vaccination card with them when they went to the doctors office. The patient had a total of 4 vaccines. After the first COVID-19 vaccine on 26Mar2021, the patients EKG showed ventricular premature complex and had an abnormal EKG. This was after the first dose, not the most recent Pfizer COVID -19 Bivalent Vaccine. After the most recent dose of the Pfizer COVID-19 Bivalent Vaccine, the patients EKG showed an abnormal T wave with ischemia and the patient was referred to a cardiologist. All previous EKGs prior to the first COVID-19 vaccine were normal. The last booster warranted a referral to a cardiologist. abnormal T wave with ischemia outcome: Patient was referred to a cardiologist. Pfizer COVID-19 Bivalent Vaccine Lot Number: The reporter did not provide the Lot and expiry information to the caller. COVID-19 Vaccine Lot Number: The reporter did not provide the Lot and expiry information to the caller.  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.