Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood pressure fluctuation, Emotional distress, Head discomfort, Hypertension
Clinical narrative: blood pressure was high; I check it in my house and went up to 151/77/increased to upwards of 130 to 140 and as high as 170/Elevated blood pressure; light pressure in my left side of my forehead; for 4 days fluctuate between 140 thru 173; sick; Pain; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Aug2023 as dose 5 (booster), single (Lot number: GK0923) at the age of 75 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (ongoing); "COPD" (ongoing); "arthritis" (ongoing); "Contract the COVID in the first year of the pandemic" (unspecified if ongoing). Concomitant medication(s) included: L-THYROXINE; METFORMIN; LISINOPRIL; GLYXAMBI; EZETIMIBE; FENOFIBRATE; BREO ELLIPTA; PRESERVISION AREDS 2; FISH OIL; VIT D3; VIT C; VIT B12; GARLIC (DEODORIZED); MAGNESIUM GLYCINATE; ECHINACEA ANGUSTIFOLIA; ASHWAGANDHA; GINSENG [PANAX GINSENG]; ZINC; CHIA SEED; FLAXSEED; TURMERIC [CURCUMA LONGA RHIZOME]; B COMPLEX [VITAMIN B COMPLEX]. The patient also took other concomitant therapy. Past drug history included: Statins, reaction(s): "Drug allergy: Statins"; Steroids, reaction(s): "Drug allergy: Steroids". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EW0196, Anatomical location: shoulder, Route of administration: Intramuscular, Time: Morning), administration date: 20Jul2021, when the patient was 73-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Batch/lot number: FA7485, Anatomical location: shoulder, Route of administration: Intramuscular, Time: Morning), administration date: 10Aug2021, when the patient was 73-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot number: FK9729, Anatomical location: shoulder, Route of administration: Intramuscular, Time: Morning), administration date: 01Feb2022, when the patient was 74-year-old, for COVID-19 immunisation; BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Batch/lot number: GJ6739, Anatomical location: shoulder, Route of administration: Intramuscular, Time: Morning), administration date: 05Dec2022, when the patient was 75-year-old, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 2023, outcome "unknown"; BLOOD PRESSURE INCREASED (medically significant) with onset 2023, outcome "not recovered", described as "blood pressure was high; I check it in my house and went up to 151/77/increased to upwards of 130 to 140 and as high as 170/Elevated blood pressure"; BLOOD PRESSURE FLUCTUATION (medically significant) with onset 2023, outcome "unknown", described as "for 4 days fluctuate between 140 thru 173"; HEAD DISCOMFORT (medically significant) with onset 2023, outcome "not recovered", described as "light pressure in my left side of my forehead"; ILLNESS (non-serious) with onset 2023, outcome "unknown", described as "sick". The events "blood pressure was high; i check it in my house and went up to 151/77/increased to upwards of 130 to 140 and as high as 170/elevated blood pressure", "light pressure in my left side of my forehead" and "for 4 days fluctuate between 140 thru 173" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood glucose: Normal blood sugar since this booster was 107-120; Blood pressure measurement: high; 151/77 mmHg; For 4 days fluctuate between 140 thru 173, notes: weeks ago; 144 mmHg; 145 the max; 110 to 120; 130 to 140; high as 170; 120 to 125 /70 to 80, notes: Systolic pressure 120 to 125 mm Hg, and Diastolic in the range of 70 to 80; elevated; Heart rate: 60; from 60-70. Therapeutic measures were not taken as a result of blood pressure increased, head discomfort, blood pressure fluctuation. Clinical course: After 2 weeks of the 4th booster patient went for follow up at doctor's office and they noticed that blood pressure was high. After that day she felt a light pressure in left side of her forehead and she checked it in her house and went up to 151/77, for 4 days fluctuate between 140 thru 173. weeks ago she went to see her cardiologist and he noticed that the BP was 144, she explained to him that this was happening since her last booster, he told her there was nothing he could do about it. Her normal blood sugar since this booster was 107-120, only if she was sick or with pain the BP went 145 the max. It was reported that, it was not an incorrect medication. It was an unexpected and troubling, persistent increase to unsafe levels of blood pressure. Patient reported that, For her entire life, including just before the 4th Covid booster was given, her blood pressure was and had been measured at 110-120 over 60 and heart rate was 60. After the 4th Covid booster her blood pressure has increased to upwards of 130 to 140 and as high as 170 over 30, 40 or 50 and heart rate from 60-70. After no symptoms, i.e medical symptom, she reported her high blood pressure reading to Pfizer, on line. Since then, she has been monitored. She wanted to know why, for no apparent reason after vaccination, her blood pressure had risen. This was very upsetting for her. The patient also received concomitant medications: SBO probiotics, Collagen Peptides, Quercetin Dihydrate with Bromelian. Covid test post vaccination was provided as yes (result for same was not provided). Patient received the survey again. She had sent this back twice already. She wished to clarify what appeared to be a misunderstanding: She never reported to Pfizer that a wrong vaccine was administered. Yet the survey appeared to indicate this, and many of the questions in the survey seem designed to determine such. She reported an adverse reaction to the last covid booster she received. This adverse reaction was very specifically Elevated blood pressure. She had had her vital signs checked on average, every 90 days for many years, and was consistently found to have blood pressure in the range of Systolic pressure 120 to 125 mm Hg, and Diastolic in the range of 70 to 80 throughout that period of time. Within two weeks after the vaccine was administered, her regular PCP noted that her blood pressure was elevated. As this was NOT normal for her, she made an appointment with a cardiologist. On her initial visit the blood pressure was elevated also. It was after that time reached out to Pfizer as the vaccine was the only medically significant event she had experienced prior to that time. She did contract COVID in the first year of the pandemic and afterwards her blood pressure was and remained normal, until she was administered the 4th booster. She wanted them to note that her blood pressure was normal after all of the previous injections, and only after the 4th was it elevated. She had blood pressure readings ranging from normal, to less than normal, to significantly elevated since Aug2023, when was administered the 4th COVID booster. In other words, her problems with blood pressure appeared only after she was administered the vaccine. She had already submitted the information regarding the booster, as well as doctors names, etc. Otherwise as nothing had changed except that she still had high blood pressure, she would not fill out any more surveys based on being administered an incorrect vaccine. She suggested if they were willing to state in writing that based on the information provided previously, she was administered the wrong vaccine she would certainly cooperate with that. The patient stated, she would really like to know what might have caused her blood pressure to rise in such a fashion.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.  Follow-up (31Jan2024): This is a spontaneous follow-up report received from the same Consumer. This Consumer (Patient) reported in response to Non-HCP letter sent which included, Updated information: reporter added, relevant medical history, lab details, event details and clinical course.  Batch/lot number is not provided, and it cannot be obtained.  Follow-up (21Feb2024): This is a spontaneous follow-up report received from consumer. Updated information included: Lab data, Relevant medical history added; Suspect details, Event (Blood pressure increased) details, Clinical course updated; Co-suspect product and Event (Wrong product administered) removed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400025619 Same reporter/Vaccine, different patient/event;