Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Stress
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [22Apr2022], this case now contains serious adverse reaction(s). A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 74 years intramuscular, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing) Note: being monitored for potential need of pacemaker; "cancer survivor" (unspecified if ongoing); "known allergies: Statins and Sulfa" (unspecified if ongoing). Additional medical history unknown. The patient took concomitant medications. Past drug history included: Statins, reaction(s): "known allergies: Statins". Vaccination history included: BNT162b2 (Previous dose product: COVID 19, brand: Pfizer, lot number: EL3249, administrator route: Intramuscular, administration date: 16Jan2021, dose number: 1, vaccine location: Left arm), administration date: 16Jan2021, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (Previous dose product: COVID 19, brand: Pfizer, lot number: EM9810, administrator route: Intramuscular, administration date: 08Feb2021, dose number: 2, vaccine location: Left arm), administration date: 08Feb2021, when the patient was 73-year-old, for COVID-19 immunization. The following information was reported: HYPERTENSION (medically significant) with onset 18Apr2022 at 21:00, outcome "recovering", described as "High Blood Pressure"; STRESS (non-serious) with onset 2022, outcome "unknown", described as "unnecessary stress". The event "high blood pressure" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (18Apr2022) 194/99, notes: had high blood pressure of 194 /99; Blood test: (18Apr2022) Normal, notes: numbers showed no sign of heart attack or stroke; (19Apr2022) Normal, notes: numbers showed no sign of heart attack or stroke; Electrocardiogram: (18Apr2022) Good, notes: EKG showed patients normal results; Heart rate: (18Apr2022) strong heart beat, notes: She had a strong heart beat that she could feel; intensity: (18Apr2022) 7/10 intensity, notes: She had a throbbing headache at the base of the neck and stated it was a 7/10 intensity. Therapeutic measures were taken as a result of hypertension. Clinical Course: Adverse event: The patient had high blood pressure of 194 /99. She had a strong heart beat that she could feel. When walking she felt her chest was being weighed down. She had a throbbing headache at the base of the neck and stated it was a 7/10 intensity. She was taken to the Local Emergency Room to be seen by a doctor due to the symptoms. The event began at 9: 00 pm on 18Apr2022, Ae resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. If patient recovered: Unknown, If treatment ae: Yes Medication to lower blood pressure. Through the follow up it was determined cause of high blood pressure was due to change in medication, and current life events causing unnecessary stress. Medication changes have been made and an additional follow up with (name withheld) physician is scheduled for 27Apr2022. No other vaccines were received within 4 weeks prior to the COVID vaccine. Prior and vaccination, patient was not diagnosed with COVID-19. No specific relevant test for Thromboembolic Events with Thrombocytopenia. Seriousness Criteria: Important Medical Event. Physician added additional blood pressure medication. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Most recent dose details were Dose 4, Pfizer vaccine, Lot number: FK9994, Administrator route: Intramuscular Administration date: 19Apr2022, Administration time: 09:15 AM, location Left arm. Patient was treated for the High Blood pressure at the ER on 18Apr2022 into the morning of 19Apr2022. Through the follow up it was determined cause of high blood pressure was due to change in medication, and current life events causing unnecessary stress. Follow-up (22Apr2022): This is a spontaneous follow-up report from a contactable consumer. This consumer reported in response to Non HCP letter sent that included: Updated information included: Patient details (address, city, state and postal code added). Lab test added. Event (High Blood pressure added). No follow-up attempts are possible. No further information is expected.